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Froio de Araujo Dias, Gabriela, Vinicius da Eira Silva, Vitor de Salles Painelli, Craig Sale, Guilherme Giannini Artioli, Bruno Gualano, and Bryan Saunders. "(In)Consistencies in Responses to Sodium Bicarbonate Supplementation: A Randomised, Repeated Measures, Counterbalanced and Double-Blind Study." PLOS ONE 10, no. 11 (November 17, 2015): e0143086. http://dx.doi.org/10.1371/journal.pone.0143086.
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HANCOX, M. "The cattle TB crisis – a radical rethink." Journal of Agricultural Science 144, no. 2 (March 6, 2006): 187. http://dx.doi.org/10.1017/s0021859606005910.
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Cattle tuberculosis in Great Britain is out of control, rising at some 18% a year, but there is great confusion as to why cattle control measures are not working (Hancox 2004a). Culling over 10000 badgers so far in the Krebs Randomised Badger Culling Trial has had no effect, despite repeated calls for mass culls by farmers and vets (Hancox 2004b). Badgers are blamed for this crisis because it is claimed cattle-to-cattle transmission is unimportant, and badgers with TB are found after repeat breakdowns in herds supposedly free of TB after negative tests.
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Harnett, Joanna, Stephen P. Myers, and Margaret Rolfe. "Probiotics and the Microbiome in Celiac Disease: A Randomised Controlled Trial." Evidence-Based Complementary and Alternative Medicine 2016 (2016): 1–16. http://dx.doi.org/10.1155/2016/9048574.
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Background. There is limited research investigating the composition of the gastrointestinal microbiota in individuals with celiac disease (CoeD) reporting only partial symptom improvement despite adherence to a strict gluten-free diet (GFD). The aim of this research was to determine if the gastrointestinal microbiota could be altered by probiotic bacteria and provide a potential new therapy for this subgroup.Methods. A multicentre RCT was conducted between January and August 2011 in Australia. Participants included 45 people with CoeD reporting only partial symptom improvement despite adherence to a strict GFD for a minimum of 12 months. Participants took 5 g of VSL#™probiotic formulation (n=23) or 5 g placebo (n=22) orally twice daily for 12 weeks. The main outcome measured was the efficacy of the probiotic formula in altering faecal microbiota counts between baseline and week 12. Safety was determined by safety blood and monitoring adverse events.Results. SPSS™multivariate repeated measures analysis (95th confidence level) revealed no statistically significant changes between the groups in the faecal microbiota counts or blood safety measures over the course of the study.Conclusion. The probiotic formula when taken orally over the 12-week period did not significantly alter the microbiota measured in this population. The trial was registered with Australian and New Zealand Clinical Trials RegisterACTRN12610000630011.
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Bonnin, C. M., C. Torrent, C. Arango, B. L. Amann, B. Solé, A. González-Pinto, J. M. Crespo, et al. "Functional remediation in bipolar disorder: 1-year follow-up of neurocognitive and functional outcome." British Journal of Psychiatry 208, no. 1 (January 2016): 87–93. http://dx.doi.org/10.1192/bjp.bp.114.162123.
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BackgroundFew randomised clinical trials have examined the efficacy of an intervention aimed at improving psychosocial functioning in bipolar disorder.AimsTo examine changes in psychosocial functioning in a group that has been enrolled in a functional remediation programme 1 year after baseline.MethodThis was a multicentre, randomised, rater-masked clinical trial comparing three patient groups: functional remediation, psychoeducation and treatment as usual over 1-year follow-up. The primary outcome was change in psychosocial functioning measured by means of the Functioning Assessment Short Test (FAST). Group×time effects for overall psychosocial functioning were examined using repeated-measures ANOVA (trial registration NCT01370668).ResultsThere was a significant group×time interaction for overall psychosocial functioning, favouring patients in the functional remediation group (F = 3.071, d.f. = 2, P = 0.049).ConclusionsImprovement in psychosocial functioning is maintained after 1-year follow-up in patients with bipolar disorder receiving functional remediation.
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Nolan, Hugh, John D. O'Connor, Orna A. Donoghue, George M. Savva, Neil O'Leary, and Rose-Anne Kenny. "Factors Affecting Reliability of Grip Strength Measurements in Middle Aged and Older Adults." HRB Open Research 3 (June 3, 2020): 32. http://dx.doi.org/10.12688/hrbopenres.13064.1.
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Background: Grip strength is a well-established marker of frailty and a good predictor of mortality that has been measured in a diverse range of samples including many population studies. The reliability of grip strength measurement in longitudinal studies is not well understood. Methods: Participants (n=130) completed a baseline and repeat health assessment in the Irish Longitudinal Study on Ageing. Grip strength was assessed using dominant and non-dominant hands (two trials on each). Repeat assessments were conducted 1-4 months later and participants were randomised into groups so that 50% changed time (morning or afternoon assessment) and 50% changed assessor between assessments. Intra-class correlation (ICC) and minimum detectable change (MDC95) were calculated and the effects of repeat assessment, time of day and assessor were determined. Results: Aggregated measures had little variation by repeat assessment or time of day; however, there was a significant effect of assessor (up to 2 kg depending on the measure used). Reliability between assessments was good (ICC>0.9) while MDC95 ranged from 5.59–7.96 kg. Non-aggregated measures alone, taken on the non-dominant hand were susceptible to repeat assessment, time of day, assessor and repeated measures within-assessment effects whereas the dominant hand was only affected by assessor. Conclusions: Mean and maximum grip strength had a higher ICC and lower MDC95 than measures on the dominant or non-dominant hands alone. The MDC95 is less than 8 kg regardless of the specific measure reported. However, changing assessor further increases variability, highlighting the need for comprehensive assessor training and avoiding changes within studies where possible.
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Rainey-Smith, Stephanie R., Belinda M. Brown, Hamid R. Sohrabi, Tejal Shah, Kathryn G. Goozee, Veer B. Gupta, and Ralph N. Martins. "Curcumin and cognition: a randomised, placebo-controlled, double-blind study of community-dwelling older adults." British Journal of Nutrition 115, no. 12 (April 22, 2016): 2106–13. http://dx.doi.org/10.1017/s0007114516001203.
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AbstractCurcumin therapy in animals has produced positive cognitive and behavioural outcomes; results of human trials, however, have been inconsistent. In this study, we report the results of a 12-month, randomised, placebo-controlled, double-blind study that investigated the ability of a curcumin formulation to prevent cognitive decline in a population of community-dwelling older adults. Individuals (n 96) ingested either placebo or 1500 mg/d BiocurcumaxTM for 12 months. A battery of clinical and cognitive measures was administered at baseline and at the 6-month and 12-month follow-up assessments. A significant time×treatment group interaction was observed for the Montreal Cognitive Assessment (repeated-measures analysis; time×treatment; F=3·85, P<0·05). Subsequent analysis revealed that this association was driven by a decline in function of the placebo group at 6 months that was not observed in the curcumin treatment group. No differences were observed between the groups for all other clinical and cognitive measures. Our findings suggest that further longitudinal assessment is required to investigate changes in cognitive outcome measures, ideally in conjunction with biological markers of neurodegeneration.
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Best, Russ, Peter S. Maulder, and Nicolas Berger. "Perceptual and Physiological Responses to Carbohydrate and Menthol Mouth-Swilling Solutions: A Repeated Measures Cross-Over Preliminary Trial." Beverages 7, no. 1 (February 1, 2021): 9. http://dx.doi.org/10.3390/beverages7010009.
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Carbohydrate and menthol mouth-swilling have been used to enhance exercise performance in the heat. However, these strategies differ in mechanism and subjective experience. Participants (n = 12) sat for 60 min in hot conditions (35 °C; 15 ± 2%) following a 15 min control period, during which the participants undertook three 15 min testing blocks. A randomised swill (carbohydrate; menthol; water) was administered per testing block (one swill every three minutes within each block). Heart rate, tympanic temperature, thermal comfort, thermal sensation and thirst were recorded every three minutes. Data were analysed by ANOVA, with carbohydrate intake controlled for via ANCOVA. Small elevations in heart rate were observed after carbohydrate (ES: 0.22 ± 90% CI: −0.09–0.52) and water swilling (0.26; −0.04–0.54). Menthol showed small improvements in thermal comfort relative to carbohydrate (−0.33; −0.63–0.03) and water (−0.40; from −0.70 to −0.10), and induced moderate reductions in thermal sensation (−0.71; from −1.01 to −0.40 and −0.66; from −0.97 to −0.35, respectively). Menthol reduced thirst by a small to moderate extent. These effects persisted when controlling for dietary carbohydrate intake. Carbohydrate and water may elevate heart rate, whereas menthol elicits small improvements in thermal comfort, moderately improves thermal sensation and may mitigate thirst; these effects persist when dietary carbohydrate intake is controlled for.
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Pettilä, Ville, Pekka Leinonen, Antti Markkola, Vilho Hiilesmaa, and Risto Kaaja. "Postpartum Bone Mineral Density in Women Treated for Thromboprophylaxis with Unfractionated Heparin or LMW Heparin." Thrombosis and Haemostasis 87, no. 02 (2002): 182–86. http://dx.doi.org/10.1055/s-0037-1612970.
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SummaryVenous thromboembolism remains an important cause of maternal mortality. In a randomised open study, 44 pregnant women with confirmed previous or current thromboembolism were randomised to receive either low-molecular-weight heparin, dalteparin (N = 21) once daily subcutaneously or unfractionated sodium heparin (UF heparin, N = 23) twice daily subcutaneously for thromboprophylaxis during pregnancy and puerperium. Bone mineral density (BMD) in the lumbosacral spine was measured with dual X-ray absorptiometry (DEXA) 1, 6, 16, 52 weeks and, if possible, 3 years after delivery. BMD values were also compared with those of healthy, delivered women (N =19).Mean BMD of the lumbar spine was significantly lower in the unfractionated heparin group compared with the dalteparin and with the control groups (repeated measures ANOVA p = 0.02). BMD in the dalteparin group did not differ from BMD of healthy delivered women. Multiple logistic regression analysis revealed that therapy was the only independent factor influencing BMD at weeks 16 and 52. Therefore we recommend use of dalteparin instead of UF heparin for long-term thromboprophylaxis during and after pregnancy.
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Berk, Michael, Rothanthi Daglas, Orwa Dandash, Murat Yücel, Lisa Henry, Karen Hallam, Craig Macneil, et al. "Quetiapinev.lithium in the maintenance phase following a first episode of mania: Randomised controlled trial." British Journal of Psychiatry 210, no. 6 (June 2017): 413–21. http://dx.doi.org/10.1192/bjp.bp.116.186833.
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BackgroundLithium and quetiapine are considered standard maintenance agents for bipolar disorder yet it is unclear how their efficacy compares with each other.AimsTo investigate the differential effect of lithium and quetiapine on symptoms of depression, mania, general functioning, global illness severity and quality of life in patients with recently stabilised first-episode mania.MethodMaintenance trial of patients with first-episode mania stabilised on a combination of lithium and quetiapine, subsequently randomised to lithium or quetiapine monotherapy (up to 800 mg/day) and followed up for 1 year. (Trial registration: Australian and New Zealand Clinical Trials Registry – ACTRN12607000639426.)ResultsIn total, 61 individuals were randomised. Within mixed-model repeated measures analyses, significant omnibus treatment × visit interactions were observed for measures of overall psychopathology, psychotic symptoms and functioning. Planned andpost hoccomparisons further demonstrated the superiority of lithium treatment over quetiapine.ConclusionsIn people with first-episode mania treated with a combination of lithium and quetiapine, continuation treatment with lithium rather than quetiapine is superior in terms of mean levels of symptoms during a 1-year evolution.
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Best, Russ, Dani Temm, Holly Hucker, and Kerin McDonald. "Repeated Menthol Mouth Swilling Affects Neither Strength nor Power Performance." Sports 8, no. 6 (June 17, 2020): 90. http://dx.doi.org/10.3390/sports8060090.
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This study aimed to assess the effects of repeated menthol mouth swilling upon strength and power performance. Nineteen (10 male) participants completed familiarisation and experimental trials of repeated menthol mouth swilling (0.1% concentration) or control (no swill) in a randomised crossover design. Participants performed an isometric mid-thigh pull (IMTP; peak and mean force; N), vertical jump (peak; cm) and six second sprint (peak and mean power; W) under each condition. Participants completed three efforts per exercise task interspersed with three-minute recoveries. Mean best values were analysed via a two-way mixed repeated measures ANOVA, and differences reported as effect sizes ± 95% confidence intervals, with accompanying descriptors and p values. Differences in peak IMTP values were unclear between familiarisation and experimental trials, and between menthol and control conditions. Mean IMTP force differed between familiarisation and control (0.51; −0.15 to 1.14; p = 0.001) and familiarisation and menthol conditions (0.50; −0.15 to 1.14; p = 0.002) by a small degree, but were unclear between control and menthol conditions. Unclear differences were also noted on vertical jump performance compared to familiarisation and between experimental conditions, with repeated six second peak and average power performance also showing unclear effects across all comparisons. We conclude that repeated menthol mouth swilling does not improve strength or power performance.
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Ahlberg, Mats Steinholtz, Hans-Olov Adami, Kerri Beckmann, Helena Bertilsson, Ola Bratt, Declan Cahill, Lars Egevad, et al. "PCASTt/SPCG-17—a randomised trial of active surveillance in prostate cancer: rationale and design." BMJ Open 9, no. 8 (August 2019): e027860. http://dx.doi.org/10.1136/bmjopen-2018-027860.
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IntroductionOvertreatment of localised prostate cancer is substantial despite increased use of active surveillance. No randomised trials help define how to monitor patients or when to initiate treatment with curative intent.Methods and analysisA randomised, multicentre, intervention trial designed to evaluate the safety of an MRI-based active surveillance protocol, with standardised triggers for repeated biopsies and radical treatment. The aim is to reduce overtreatment of prostate cancer. 2000 men will be randomly allocated to either surveillance according to current practice or to standardised triggers at centres in Sweden, Norway, Finland and the UK. Men diagnosed in the past 12 months with prostate cancer, ≤T2a, prostate-specific antigen (PSA) <15 ng/mL, PSA density ≤0.2 ng/mL/cc, any International Society of Urological Pathology (ISUP) grade 1 are eligible. Men with ISUP grade 2 in <30% of cores on systematic biopsy and <10 mm cancer in one core on systematic or targeted biopsy are also eligible. Men diagnosed on systematic biopsy should have an MRI and targeted biopsies against Prostate Imaging and Reporting Data System V.2 3–5 lesions before inclusion. Identical follow-up in the two study arms: biannual PSA testing, yearly clinical examination and MRI every second year. In the experimental arm, standardised triggers based on MRI and PSA density elicit repeated biopsies. MRI and histopathological progression trigger radical treatment. Primary outcome measure is progression-free survival. Secondary outcome measures are cumulative incidence of metastatic disease, treatments with curative intent, pT3-4 at radical prostatectomy, switch to watchful waiting, prostate cancer mortality and quality of life. Inclusion started in October 2016 and in October 2018; 275 patients have been enrolled.Ethics and disseminationEthical approval was obtained in each participating country. Results for the primary and secondary outcome measures will be submitted for publication in peer-reviewed journals.Trial registration numberNCT02914873.
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Stanford, Gemma, Jane C. Davies, Omar Usmani, Winston Banya, Susan Charman, Mandy Jones, Nicholas J. Simmonds, and Diana Bilton. "Investigating outcome measures for assessing airway clearance techniques in adults with cystic fibrosis: protocol of a single-centre randomised controlled crossover trial." BMJ Open Respiratory Research 7, no. 1 (October 2020): e000694. http://dx.doi.org/10.1136/bmjresp-2020-000694.
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IntroductionAirway clearance techniques (ACTs) are a gold standard of cystic fibrosis management; however, the majority of research evidence for their efficacy is of low standard; often attributed to the lack of sensitivity from outcome measures (OMs) used historically. This randomised controlled trial (RCT) investigates these standard OMs (sputum weight, forced expiratory volume in 1 s) and new OMs (electrical impedance tomography (EIT), multiple breath washout (MBW) and impulse oscillometry (IOS)) to determine the most useful measures of ACT.Methods and analysisThis is a single-centre RCT with crossover design. Participants perform MBW, IOS and spirometry, and then are randomised to either rest or supervised ACT lasting 30–60 min. MBW, IOS and spirometry are repeated immediately afterwards. EIT and sputum are collected during rest/ACT. On a separate day, the OMs are performed with the other intervention. Primary endpoint is difference in change in OMs before and after ACT/rest. Sample size was calculated with 80% power and significance of 5% for each OM (target n=64).Ethics and disseminationEthics approval was gained from the London–Chelsea Research Ethics Committee (reference 16/LO/0995, project ID 154635). Dissemination will involve scientific conference presentation and publication in a peer-reviewed journal.Trial registration numbersISRCTN11220163 and NCT02721498.
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Banerjee, Gourav, Michelle Briggs, and Mark I. Johnson. "The immediate effects of kinesiology taping on cutaneous blood flow in healthy humans under resting conditions: A randomised controlled repeated-measures laboratory study." PLOS ONE 15, no. 2 (February 21, 2020): e0229386. http://dx.doi.org/10.1371/journal.pone.0229386.
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de Faria, Stephanie Martins, Daiene de Morais Fabrício, Vitor Tumas, Paula Costa Castro, Moacir Antonelli Ponti, Jaime EC Hallak, Antonio W. Zuardi, José Alexandre S. Crippa, and Marcos Hortes Nisihara Chagas. "Effects of acute cannabidiol administration on anxiety and tremors induced by a Simulated Public Speaking Test in patients with Parkinson’s disease." Journal of Psychopharmacology 34, no. 2 (January 7, 2020): 189–96. http://dx.doi.org/10.1177/0269881119895536.
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Background: Cannabidiol (CBD) is one of the main components of Cannabis sativa and has anxiolytic properties, but no study has been conducted to evaluate the effects of CBD on anxiety signs and symptoms in patients with Parkinson’s disease (PD). This study aimed to evaluate the impacts of acute CBD administration at a dose of 300 mg on anxiety measures and tremors induced by a Simulated Public Speaking Test (SPST) in individuals with PD. Methods: A randomised, double-blinded, placebo-controlled, crossover clinical trial was conducted. A total of 24 individuals with PD were included and underwent two experimental sessions within a 15-day interval. After taking CBD or a placebo, participants underwent the SPST. During the test, the following data were collected: heart rate, systemic blood pressure and tremor frequency and amplitude. In addition, the Visual Analog Mood Scales (VAMS) and Self-Statements during Public Speaking Scale were applied. Statistical analysis was performed by repeated-measures analysis of variance (ANOVA) while considering the drug, SPST phase and interactions between these variables. Results: There were statistically significant differences in the VAMS anxiety factor for the drug; CBD attenuated the anxiety experimentally induced by the SPST. Repeated-measures ANOVA showed significant differences in the drug for the variable related to tremor amplitude as recorded by the accelerometer. Conclusion: Acute CBD administration at a dose of 300 mg decreased anxiety in patients with PD, and there was also decreased tremor amplitude in an anxiogenic situation.
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Geraghty, Adam W. A., Lisa Roberts, Jonathan Hill, Nadine E. Foster, Lucy Yardley, Elaine Hay, Beth Stuart, et al. "Supporting self-management of low back pain with an internet intervention in primary care: a protocol for a randomised controlled trial of clinical and cost-effectiveness (SupportBack 2)." BMJ Open 10, no. 8 (August 2020): e040543. http://dx.doi.org/10.1136/bmjopen-2020-040543.
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IntroductionSelf-management and remaining physically active are first-line recommendations for the care of patients with low back pain (LBP). With a lifetime prevalence of up to 85%, novel approaches to support behavioural self-management are needed. Internet interventions may provide accessible support for self-management of LBP in primary care. The aim of this randomised controlled trial is to determine the clinical and cost-effectiveness of the ‘SupportBack’ internet intervention, with or without physiotherapist telephone support in reducing LBP-related disability in primary care patients.Methods and analysisA three-parallel arm, multicentre randomised controlled trial will compare three arms: (1) usual primary care for LBP; (2) usual primary care for LBP and an internet intervention; (3) usual primary care for LBP and an internet intervention with additional physiotherapist telephone support. Patients with current LBP and no indicators of serious spinal pathology are identified and invited via general practice list searches and mailouts or opportunistic recruitment following LBP consultations. Participants undergo a secondary screen for possible serious spinal pathology and are then asked to complete baseline measures online after which they are randomised to an intervention arm. Follow-ups occur at 6 weeks, 3, 6 and 12 months. The primary outcome is physical function (using the Roland and Morris Disability Questionnaire) over 12 months (repeated measures design). Secondary outcomes include pain intensity, troublesome days in pain over the last month, pain self-efficacy, catastrophising, kinesophobia, health-related quality of life and cost-related measures for a full health economic analysis. A full mixed-methods process evaluation will be conducted.Ethics and disseminationThis trial has been approved by a National Health Service Research Ethics Committee (REC Ref: 18/SC/0388). Results will be disseminated through peer-reviewed journals, conferences, communication with practices and patient groups. Patient representatives will support the implementation of our full dissemination strategy.Trial registration numberISRCTN14736486.
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Uehara, Denise L., Christy M. Nishita, Tammy Tom, and Landry Fukunaga. "The Influence of Individualised Supports on the Self-Efficacy of Employed Diabetics in Hawai'i: Findings from a Mixed Method Study." Journal of Pacific Rim Psychology 5, no. 2 (December 2011): 65–74. http://dx.doi.org/10.1017/s1834490900000593.
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Self-management is a key component of diabetes care and enhancing patient self-efficacy is an important factor. Typical diabetes education programs include strategies to increase self-efficacy, but little information exists about the effectiveness of such programs within Asian and Pacific populations. The Hawai'i Demonstration to Maintain Independence and Employment was a federally funded, community-based randomised trial in which treatment group participants received individualised life coaching and pharmacist counselling over a 12-month period. The study measured changes in diabetes self-efficacy among treatment and control group participants using repeated measures analysis of covariance. Focus group findings provided a comprehensive picture of participants' perception of their experiences in the trial and more specifically the individualised intervention. There was a significant effect of the intervention on diabetes self-efficacy at the p < .01 level [F(1, 187) = 10.40, p = .002]. These findings demonstrate the efficacy of individually tailored approaches to diabetes self-management within a diverse, employed sample.
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Holbert, Maleea Denise, Roy M. Kimble, Mark Chatfield, and Bronwyn R. Griffin. "Effectiveness of a hydrogel dressing as an analgesic adjunct to first aid for the treatment of acute paediatric burn injuries: a prospective randomised controlled trial." BMJ Open 11, no. 1 (January 2021): e039981. http://dx.doi.org/10.1136/bmjopen-2020-039981.
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ObjectiveTo compare the effectiveness of two acute burn dressings, Burnaid hydrogel dressing and plasticised polyvinylchloride film, on reducing acute pain scores in paediatric burn patients following appropriate first aid.DesignSingle-centre, superiority, two-arm, parallel-group, prospective randomised controlled trial.Participants and settingPaediatric patients (aged ≤16) presenting to the Emergency Department at the Queensland Children’s Hospital, Brisbane, Australia, with an acute thermal burn were approached for participation in the trial from September 2017–September 2018.InterventionsPatients were randomised to receive either (1) Burnaid hydrogel dressing (intervention) or (2) plasticised polyvinylchloride film (Control) as an acute burn dressing.Primary and secondary outcomesObservational pain scores from nursing staff assessed 5 min post application of the randomised dressing, measured using the Face Legs Activity Cry and Consolability Scale was the primary outcome. Repeated measures of pain, stress and re-epithelialisation were also collected at follow-up dressing changes until 95% wound re-epithelialisation occurred.ResultsSeventy-two children were recruited and randomised (n=37 intervention; n=35 control). No significant between-group differences in nursing (mean difference: −0.1, 95% CI −0.7 to 0.5, p=0.72) or caregiver (MD: 1, 95% CI −8 to 11, p=0.78) observational pain scores were identified. Moreover, no significant differences in child self-report pain (MD: 0.3, 95% CI −1.7 to 2.2, p=0.78), heart rate (MD: −3, 95% CI −11 to 5, p=0.41), temperature (MD: 0.6, 95% CI −0.13 to 0.24, p=0.53), stress (geometric mean ratio: 1.53, 95% CI 0.93 to 2.53, p=0.10), or re-epithelialisation rates (MD: −1, 95% CI −3 to 1, p=0.26) were identified between the two groups.ConclusionsA clear benefit of Burnaid hydrogel dressing as an analgesic adjunct to first aid for the treatment of acute paediatric burns was not identified in this investigation.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12617001274369).
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Donoghue, Orna A., George M. Savva, Axel Börsch-Supan, and Rose Anne Kenny. "Reliability, measurement error and minimum detectable change in mobility measures: a cohort study of community-dwelling adults aged 50 years and over in Ireland." BMJ Open 9, no. 11 (November 2019): e030475. http://dx.doi.org/10.1136/bmjopen-2019-030475.
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ObjectiveTo estimate the effects of repeat assessments, rater and time of day on mobility measures and to estimate their variation between and within participants in a population-based sample of Irish adults aged ≥50 years.DesignTest–retest study in a population representative sample.SettingAcademic health assessment centre of The Irish Longitudinal Study on Ageing (TILDA).Participants128 community-dwelling adults from the Survey for Health, Ageing and Retirement in Europe (SHARE) Ireland study who agreed to take part in the SHARE-Ireland/TILDA collaboration.InterventionsNot applicable.Outcome measuresParticipants performed timed up-and-go (TUG), repeated chair stands (RCS) and walking speed tests administered by one of two raters. Repeat assessments were conducted 1–4 months later. Participants were randomised with respect to a change in time (morning, afternoon) and whether the rater was changed between assessments. Within and between-participant variance for each measure was estimated using mixed-effects models. Intraclass correlation (ICC), SE of measurement and minimum detectable change (MDC) were reported.ResultsAverage performance did not vary between baseline and repeat assessments in any test, except RCS. The rater significantly affected performance on all tests except one, but time of day did not. Reliability varied from ICC=0.66 (RCS) to ICC=0.88 (usual gait speed). MDC was 2.08 s for TUG, 4.52 s for RCS and ranged from 19.49 to 34.73 cm/s for walking speed tests. There was no evidence for lower reliability of gait parameters with increasing time between assessments.ConclusionsReliability varied for each test when measurements are obtained over 1–4 months with most variation due to rater effects. Usual and motor dual task gait speed demonstrated highest reliability.
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Ma, Jun, Peg Strub, Nan Lv, Lan Xiao, Carlos A. Camargo, A. Sonia Buist, Philip W. Lavori, Sandra R. Wilson, Kari C. Nadeau, and Lisa G. Rosas. "Pilot randomised trial of a healthy eating behavioural intervention in uncontrolled asthma." European Respiratory Journal 47, no. 1 (October 22, 2015): 122–32. http://dx.doi.org/10.1183/13993003.00591-2015.
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Rigorous research on the benefit of healthy eating patterns for asthma control is lacking.We randomised 90 adults with objectively confirmed uncontrolled asthma and a low-quality diet (Dietary Approaches to Stop Hypertension (DASH) scores <6 out of 9) to a 6-month DASH behavioural intervention (n=46) or usual-care control (n=44). Intention-to-treat analyses used repeated-measures mixed models.Participants were middle-aged, 67% female and multiethnic. Compared with controls, intervention participants improved on DASH scores (mean change (95% CI) 0.6 (0, 1.1) versus −0.3 (−0.8, 0.2); difference 0.8 (0.2, 1.5)) and the primary outcome, Asthma Control Questionnaire scores (−0.2 (−0.5, 0) versus 0 (−0.3, 0.3); difference −0.2 (−0.5, 0.1)) at 6 months. The mean group differences in changes in Mini Asthma Quality of Life Questionnaire overall and subdomain scores consistently favoured the intervention over the control group: overall 0.4 (95% CI 0, 0.8), symptoms 0.5 (0, 0.9), environment 0.4 (−0.1, 1.0), emotions 0.4 (−0.2, 0.9) and activities 0.3 (0, 0.7). These differences were modest, but potentially clinical significant.The DASH behavioural intervention improved diet quality with promising clinical benefits for better asthma control and functional status among adults with uncontrolled asthma. A full-scale efficacy trial is warranted.
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MacPherson, Hugh, Helen Tilbrook, Deborah Agbedjro, Hannah Buckley, Catherine Hewitt, and Chris Frost. "Acupuncture for Irritable Bowel Syndrome: 2-Year Follow-Up of a Randomised Controlled Trial." Acupuncture in Medicine 35, no. 1 (February 2017): 17–23. http://dx.doi.org/10.1136/acupmed-2015-010854.
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Background A recent randomised controlled trial (RCT) of acupuncture as a treatment for irritable bowel syndrome (IBS) demonstrated sustained benefits over a period of 12 months post-randomisation. Aim To extend the trial follow-up to evaluate the effects of acupuncture at 24 months post-randomisation. Methods Patients in primary care with ongoing IBS were recruited to a two-arm pragmatic RCT of acupuncture for IBS. Participants were randomised to the offer of up to 10 weekly sessions of acupuncture plus usual care (n=116 patients) or to continue with usual care alone (n=117). The primary outcome was the self-reported IBS symptom severity score (IBS SSS) measured at 24 months post-randomisation. Analysis was by intention-to-treat using an unstructured multivariate linear model incorporating all repeated measures. Results The overall response rate was 61%. The adjusted difference in mean IBS SSS at 24 months was −18.28 (95% CI −40.95 to 4.40) in favour of the acupuncture arm. Differences at earlier time points estimated from the multivariate model were: −27.27 (−47.69 to −6.86) at 3 months; −23.69 (−45.17 to −2.21) at 6 months; −24.09 (−45.59 to −2.59) at 9 months; and −23.06 (−44.52 to −1.59) at 12 months. Conclusions There were no statistically significant differences between the acupuncture and usual care groups in IBS SSS at 24 months post-randomisation, and the point estimate for the mean difference was approximately 80% of the size of the statistically significant results seen at 6, 9 and 12 months. Trial registration number ISRCTN08827905.
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Amsberg, Susanne, Ingrid Wijk, Fredrik Livheim, Eva Toft, Unn-Britt Johansson, and Therese Anderbro. "Acceptance and commitment therapy (ACT) for adult type 1 diabetes management: study protocol for a randomised controlled trial." BMJ Open 8, no. 11 (November 2018): e022234. http://dx.doi.org/10.1136/bmjopen-2018-022234.
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IntroductionIntegrating diabetes self-management into daily life involves a range of complex challenges for affected individuals. Environmental, social, behavioural and emotional psychological factors influence the lives of those with diabetes. The aim of this study is to evaluate the impact of a stress management group intervention based on acceptance and commitment therapy (ACT) among adults living with poorly controlled type 1 diabetes.Methods and analysisThis study will use a randomised controlled trial design evaluating treatment as usual (TAU) and ACT versus TAU. The stress management group intervention will be based on ACT and comprises a programme divided into seven 2-hour sessions conducted over 14 weeks. A total of 70 patients who meet inclusion criteria will be recruited over a 2-year period with follow-up after 1, 2 and 5 years.The primary outcome measure will be HbA1c. The secondary outcome measures will be the Depression Anxiety Stress Scales, the Swedish version of the Hypoglycemia Fear Survey, the Swedish version of the Problem Areas in Diabetes Scale, The Summary of Self-Care Activities, Acceptance Action Diabetes Questionnaire, Swedish Acceptance and Action Questionnaire and the Manchester Short Assessment of Quality of Life. The questionnaires will be administered via the internet at baseline, after sessions 4 (study week 7) and 7 (study week 14), and 6, 12 and 24 months later, then finally after 5 years. HbA1cwill be measured at the same time points.Assessment of intervention effect will be performed through the analysis of covariance. An intention-to-treat approach will be used. Mixed-model repeated measures will be applied to explore effect of intervention across all time points.Ethics and disseminationThe study has received ethical approval (Dnr: 2016/14-31/1). The study findings will be disseminated through peer-reviewed publications, conferences and reports to key stakeholders.Trial registration numberNCT02914496; Pre-results.
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Banerjee, Gourav, Michelle Briggs, and Mark I. Johnson. "The effects of kinesiology taping on experimentally-induced thermal and mechanical pain in otherwise pain-free healthy humans: A randomised controlled repeated-measures laboratory study." PLOS ONE 14, no. 12 (December 10, 2019): e0226109. http://dx.doi.org/10.1371/journal.pone.0226109.
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Koike, S., S. Yamaguchi, Y. Ojio, K. Ohta, T. Shimada, K. Watanabe, G. Thornicroft, and S. Ando. "A randomised controlled trial of repeated filmed social contact on reducing mental illness-related stigma in young adults." Epidemiology and Psychiatric Sciences 27, no. 2 (December 19, 2016): 199–208. http://dx.doi.org/10.1017/s2045796016001050.
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Aims.Public stigma alters attitudes towards people with mental illness, and is a particular concern for young people since most mental health problems occur in adolescence and young adulthood. However, little is known about the long-term effects of repeated filmed social contact (FSC) on reducing mental health-related stigma among young adults in the general population, compared with self-instructional Internet search (INS) and control interventions.Methods.This study is a parallel-group randomised controlled trial over 12 months conducted in Tokyo, Japan. A total of 259 university students (male n = 150, mean age = 20.0 years, s.d. = 1.2) were recruited from 20 colleges and universities between November 2013 and July 2014, without being provided information about the mental health-related survey or trial. Participants were assigned to one of three groups before completion of the baseline survey (FSC/INS/control = 89/83/87). The FSC group received a computer-based 30-min social contact film with general mental health education and five follow-up web-based FSCs at 2-month intervals. The INS group undertook a 30-min search for mental health-related information with five follow-up web-based reminders for self-instructional searches at 2-month intervals. The control group played PC games and had no follow-up intervention. The main outcome measures were the future (intended behaviour) domain of the Reported and Intended Behaviour Scale at 12 months after the intervention. Analysis was conducted in September 2015.Results.At the 12-month follow-up, 218 participants completed the survey (84.1%, 75:70:73). The FSC group showed the greatest change at the 12-month follow-up (FSC: mean change 2.11 [95% CI 1.49, 2.73], INS: 1.04 [0.29, 1.80], control: 0.71 [0.09, 1.33]; FSC v. INS p = 0.037, FSC v. controls p = 0.004). No adverse events were reported during the follow-up period.Conclusions.FSC was more successful in reducing stigma at 12 months after intervention than INS or control interventions. FSC could be used to reduce stigma in educational lectures and anti-stigma campaigns targeted at young people.Study registration.This study is registered at UMIN-CTR (No. UMIN000012239).
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(Suei) Lin, Ssu-Yu, Ngaire Kerse, Christine McLean, and Simon Moyes. "Validation of quality of life and functional measures for older people for telephone administration." Journal of Primary Health Care 2, no. 1 (2010): 35. http://dx.doi.org/10.1071/hc10035.
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INTRODUCTION: Quality of life (QoL) and functional status are important aspects of health especially for older people. Efficient and valid ways of measuring older peoples health is of great importance. AIM: This project aims to establish the reliability of use of (1) a quality of life measure, the WHOQOL-BREF, and (2) a functional measure, the Nottingham Extended Activities of Daily Living scale (NEADL), for use over the telephone. METHODS: With ethical approval, patients over age 75 years (65 years if Maori) have been enrolled in the BRIGHT trial; a randomised controlled trial testing a practice-based screening initiative to prevent disability. Participants with possible disability, defined as being unable to get in and out of the car or take hot drinks from one room to another, completed a telephone interview including the two measures. Seventy participants repeated the two measures during a face-to-face interview within three months. RESULTS: Both WHOQOL-BREF and NEADL scores for the two forms of administration produced high Pearson correlation coefficients. There was good agreement for the WHOQOL-BREF as shown by the Bland-Altman graphs; however there was a tendency of a greater negative difference the greater the average score became (higher level of function) for the NEADL. DISCUSSION: This study shows that telephone interviews can generally provide a valid method to assess the quality of life and function in older people. KEYWORDS: Reliability; Quality of life; WHOQOL-BREF; functional status; NEADL; telephone administration
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Urichuk, Liana, Marianne Hrabok, Katherine Hay, Pamela Spurvey, Daniella Sosdjan, Michelle Knox, Allen Fu, et al. "Enhancing peer support experience for patients discharged from acute psychiatric care: protocol for a randomised controlled pilot trial." BMJ Open 8, no. 8 (August 2018): e022433. http://dx.doi.org/10.1136/bmjopen-2018-022433.
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IntroductionThis study will evaluate the effectiveness of an innovative peer support programme. The programme incorporates leadership training, mentorship, recognition and reward systems for peer support workers, and supportive/reminder text messaging for patients discharged from acute (hospital) care. We hypothesise that patients enrolled in the peer support system plus daily supportive/reminder text messages condition will achieve superior outcomes in comparison to other groups.Methods and analysisThis is a prospective, rater-blinded, four-arm randomised controlled trial. 180 patients discharged from acute psychiatric care in Edmonton, Alberta, Canada will be randomised to one of four conditions: (1) enrolment in a peer support system; (2) enrolment in a peer support system plus automated daily supportive/reminder text messages; (3) enrolment in automated daily supportive/reminder text messages alone; or (4) treatment as usual follow-up care. Patients in each group will complete evaluation measures (eg, recovery, general symptomatology and functional outcomes) at baseline, 6 months and 12months. Patient service utilisation data and clinician-rated measures will also be used to gauge patient progress. Patient data will be analysed with descriptive statistics, repeated measures and correlational analyses. The peer support worker experience will be captured using qualitative methods.Ethics and disseminationThe study will be conducted in accordance with the Declaration of Helsinki (Hong Kong Amendment) and Good Clinical Practice (Canadian Guidelines). The study has received ethical clearance from the Health Ethics Research Board of the University of Alberta (Ref # Pro00078427) and operational approval from our regional health authority (AHS- (PRJ) #35293). All participants will provide informed consent prior to study inclusion. The results will be disseminated at several levels, including patients/peer supports, practitioners, academics/researchers, and healthcare organisations.Trial registration numberNCT03404882; Pre-results.
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Bishop, Joshua, Lissa Spencer, and Jennifer Alison. "Effect of a pulmonary rehabilitation programme of 8 weeks compared to 12 weeks duration on exercise capacity in people with chronic obstructive pulmonary disease (PuRe Duration): protocol for a randomised controlled trial." BMJ Open Respiratory Research 7, no. 1 (September 2020): e000687. http://dx.doi.org/10.1136/bmjresp-2020-000687.
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IntroductionPulmonary rehabilitation (PR) is a key component in the management of chronic obstructive pulmonary disease (COPD). There is no strong evidence on the optimal duration of PR programmes. The aim of this study is to determine whether an 8-week PR programme is equivalent to a 12-week PR programme in people with COPD.Methods and analysisThis study will be a prospective, multisite, randomised controlled, equivalence trial with assessors blinded to group allocation and intention-to-treat analysis. 72 participants with COPD will be recruited and randomised to either a supervised, twice weekly for 8 weeks or a 12-week PR programme of exercise training and education. Primary outcome: endurance shuttle walk test. Secondary outcomes: will include St George’s Respiratory Questionnaire, 6-min walk distance, COPD assessment test, Hospital Anxiety and Depression Scale, physical activity monitoring and hospital admissions at 6 months and 12 months. Repeated measures analysis of variance will be used to analyse differences between the groups for all outcomes.Ethics and disseminationEthics approval was gained from all participating sites. Results of the trial will be submitted for publication in a peer-reviewed journal.Trial registration numberACTRN12616001586404.
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Ray, Carola, Rejane Figueiredo, Riikka Pajulahti, Henna Vepsäläinen, Elviira Lehto, Reetta Lehto, Maijaliisa Erkkola, and Eva Roos. "Effects of the Preschool-Based Family-Involving DAGIS Intervention on Family Environment: A Cluster Randomised Trial." Nutrients 12, no. 11 (November 4, 2020): 3387. http://dx.doi.org/10.3390/nu12113387.
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Interventions promoting young children’s healthy energy balance-related behaviours (EBRBs) should also examine changes in the family environment as this is an important determinant that may affect the effectiveness of the intervention. This study examines family environmental effects of the Increased Health and Wellbeing in Preschools (DAGIS) intervention study, and whether these effects differed when considering three parental educational level (PEL) groups. The DAGIS intervention was conducted in preschools and involving parents in Southern Finland from September 2017 to May 2018. It was designed as a randomised trial, clustered at preschool-level. Parents of 3–6-year-olds answered questionnaires recording PEL, parental role modelling for EBRBs, and the family environment measured as EBRBs availability and accessibility. Linear Mixed Models with Repeated Measures were used in order to detect intervention effects. Models included group by time interactions. When examining intervention effects separated by PEL groups, models with three-level interactions (group × time-points × PEL) were evaluated. There was an interaction effect for the availability of sugary everyday foods and drinks (p = 0.002). The analyses showed that the control group increased availability (p = 0.003), whereas in the intervention group no changes were detected (p = 0.150). In the analysis separated by PEL groups, changes were found only for the accessibility of sugary treats at home; the high PEL control group increased the accessibility of sugary treats (p = 0.022) (interaction effect: p = 0.027). Hence, results suggest that the DAGIS multicomponent intervention had a limited impact on determinants for children’s healthy EBRBs, and no impact was found in the low PEL group.
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Guo, Yongfang, Mingqing Xing, Wenjuan Sun, Xiaoyan Yuan, Hongyan Dai, and Huamin Ding. "Plasma Nesfatin-1 Level in Obese Patients after Acupuncture: A Randomised Controlled Trial." Acupuncture in Medicine 32, no. 4 (August 2014): 313–17. http://dx.doi.org/10.1136/acupmed-2014-010530.
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Background Nesfatin-1 is an anorexigenic hormone suggested to regulate obesity. Objective To investigate the relationship between nesfatin-1 level and anthropometric and metabolic parameters in obese patients, and examine the change in plasma nesfatin-1 level after acupuncture treatment. Methods 64 obese adult patients without diabetes and 58 normal weight control subjects were enrolled in this study. The obese patients were randomly divided into an acupuncture plus diet group (n=32) and a diet only group (n=32). Measurements were repeated after 45 days. Results Body mass index (BMI), waist and hip circumferences, serum insulin, lipoprotein and insulin resistance measures were significantly higher, and plasma nesfatin-1 level was significantly lower, in obese patients than in normal weight controls. In addition, negative correlations were found between plasma nesfatin-1 level and BMI, waist and hip circumferences. Weight reduction in participants after acupuncture and diet restriction was 7.0% and 4.3%, respectively. Plasma nesfatin-1 level increased from 2.75±1.16 to 3.44±1.28 ng/mL and from 2.86±1.07 to 3.23±1.06 ng/mL in acupuncture and diet groups, respectively; the difference was significant, p<0.05. Conclusions Plasma nesfatin-1 level is reduced in obese adults, and is increased after acupuncture. The beneficial effect of acupuncture on obesity is associated with increased plasma nesfatin-1 level.
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Keahey, Robin, Nicole White, Annie Duchesne, and Chelsea A. Pelletier. "A theory-grounded text message–based intervention to reduce sedentary behaviour in university students." Health Education Journal 80, no. 6 (April 10, 2021): 672–85. http://dx.doi.org/10.1177/00178969211007163.
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Objective: To evaluate the feasibility and acceptability of a theory-grounded, text message–based intervention targeting sedentary behaviour among university students. Design: Single-group repeated measures design. Setting: Post-secondary institution in British Columbia, Canada. Methods: Data concerning students’ sedentary behaviour were collected via online survey completed at three time points over the course of one university semester: baseline (T1), post-intervention (T2) and 2-week follow-up (T3). The 6-week intervention comprised four weekly text messages delivered to participants’ mobile devices. Participants’ attitudes regarding the intervention were evaluated together with other measures including constructs in the Health Action Process Approach (HAPA). Sedentary behaviour and physical activity were measured using the Physical Activity and Sedentary Behaviour Questionnaire (PASB-Q). Results: The intervention was generally well received by participants. Preliminary, observational data suggest some indices of user experience were statistically associated with behavioural outcomes and may inform future work. Hours per week of sedentary behaviour did not change across time points, whereas minutes per week of physical activity decreased significantly from baseline to follow-up. Conclusion: While study findings suggest minor modifications to the intervention may improve participants’ engagement, we demonstrated overall that a theory-grounded, text message–based intervention to reduce sedentary behaviour can be feasibly implemented. The efficacy of this intervention should be tested through a randomised control trial with a representative sample of the student population.
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Santos, Ana Eliza Castanho Garrini dos, Sandra Kalil Bussadori, Marcelo Mendes Pinto, Dácio Antonio Pantano Junior, Aldo Brugnera Jr, Fátima Antonia Aparecida Zanin, Maria Fernanda Setúbal Destro Rodrigues, Lara Jansiski Motta, and Anna Carolina Ratto Tempestini Horliana. "Evaluation of in-office tooth whitening treatment with violet LED: protocol for a randomised controlled clinical trial." BMJ Open 8, no. 9 (September 2018): e021414. http://dx.doi.org/10.1136/bmjopen-2017-021414.
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IntroductionIn-office tooth whitening treatment using violet light emited diode (LED) (405 nm) is a novel bleaching method that causes less sensitivity while offering the same effectiveness as the gold standard (35% hydrogen peroxide, H2O2). This study describes a protocol for the first randomised controlled clinical trial to compare the effects of the two methods.Methods and analysisEighty patients will be divided into four groups: G1 violet LED; G2 violet LED +35% carbamide peroxide; G3 35% H2O2and G4 violet LED +gingivoplasty. Colour will be measured at baseline, immediately after the first session and at the 15 and 180 days follow-up using the Vita Classical and the digital Easyshade V spectrophotometer (Vita, Zahnfabrik, Germany). Sensitivity after whitening will be measured using the Visual Analogue Scale at baseline and at each session in all groups and in all follow-ups. The tissue removed during gingivoplasty (G4) will be submitted to immunohistochemical analysis for the determination of inflammatory changes caused by violet LED. The Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ) will be evaluated before, as well as at established time point controls. The results will be expressed as mean and SD values. After determining the normality of the data, a one-way repeated-measures analysis of variance will be used for the comparison of data with normal distribution and the Kruskal-Wallis test will be used for data with non-normal distribution. A p<0.05 will be considered indicative of statistical significance. After determining the normality of the data, the Kruskal-Wallis test will be used for non-parametric data. Multivariate analysis of variance (MANOVA) and the Wilcoxon test will be used for comparing data from the PIDAQ.Ethics and disseminationThis protocol has been approved by the Human Research Ethics Committee of UniversidadeNove de Julho (certificate: 2.034.518). The findings will be published in a peer-reviewed journal.Trial registration numberNCT03192852; Pre-results.
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Hatton, Anna L., Elise M. Gane, Jayishni N. Maharaj, Joshua Burns, Joanne Paton, Graham Kerr, and Keith Rome. "Textured shoe insoles to improve balance performance in adults with diabetic peripheral neuropathy: study protocol for a randomised controlled trial." BMJ Open 9, no. 7 (July 2019): e026240. http://dx.doi.org/10.1136/bmjopen-2018-026240.
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IntroductionPeripheral neuropathy is a major risk factor for falls in adults with diabetes. Innovative footwear devices which artificially manipulate the sensory environment at the feet, such as textured shoe insoles, are emerging as an attractive option to mitigate balance and walking problems in neuropathic populations. This study aims to explore whether wearing textured insoles for 4 weeks alters balance performance in adults with diabetic peripheral neuropathy.Methods and analysisA prospective, single-blinded randomised controlled trial with parallel groups will be conducted on 70 adults with diabetic peripheral neuropathy. Adults with a diagnosis of peripheral neuropathy (secondary to type 2 diabetes), aged ≥18 years, ambulant over 20 m (with/without an assistive device), will be recruited. Participants will be randomised to receive a textured insole (n=35) or smooth insole (n=35), to be worn for 4 weeks. During baseline and post intervention assessments, standing balance (foam/firm surface; eyes open/closed) and walking tasks will be completed barefoot, wearing standard shoes only, and two different insoles (smooth, textured). The primary outcome measure will be centre of pressure (CoP) velocity, with higher values indicating poorer balance. Secondary outcome measures include walking quality (gait velocity, base of support, stride length and double-limb support time), physical activity levels, foot sensation (light-touch pressure, vibration) and proprioception (ankle joint position sense), and other balance parameters (CoP path length, anteroposterior and mediolateral excursion). Patient-reported outcomes will be completed evaluating foot health, frequency of falls and fear of falling. Data will be analysed using a repeated measures mixed models approach (including covariates) to establish any differences between-groups, for all outcome measures, over the intervention period.Ethics and disseminationEthical approval has been obtained from the institutional Human Research Ethics Committee (#2017000098). Findings will be disseminated at national and international conferences, through peer-reviewed journals, workshops and social media.Trial registration numberACTRN12617000543381; Pre-results.
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Clark, JR. "High-intensity exercise and recovery during short-term supplementation with creatine plus a protein-carbohydrate formula." South African Journal of Sports Medicine 18, no. 4 (December 15, 2006): 136. http://dx.doi.org/10.17159/2078-516x/2006/v18i4a236.
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Objective. To determine the effect of short-term creatine supplementation plus a protein-carbohydrate formula on high-intensity exercise performance and recovery. Design. A repeated-measures, experimental study, employing a randomised, double-blind, placebo-controlled, group comparison design was used. Interventions. Thirty active but not sprint-trained male subjects were randomly assigned to 1 of 3 groups: creatine plus protein-carbohydrate formula (CRF); creatine only (CRE); and control (CON). All groups were exposed to the same high-intensity sprint exercise programme, 3 times per week for 30 days. Main outcome measures. Dependant variables included total repeat sprint distance, fatigue index, perceived muscle pain, and blood lactate, urea, creatine kinase, and cortisol concentrations. Results. All groups significantly (p ≤ 0.05) increased total sprint distance and decreased blood urea concentrations. There were no significant changes in blood lactate or cortisol concentrations in any group. CRF showed significant decreases (p ≤ 0.05) in fatigue index, muscle pain, and creatine kinase concentration. However, no significant differences were found between groups. Conclusion. Short-term creatine supplementation with or without protein-carbohydrate supplementation does not appear to enhance performance or recovery significantly over high-intensity exercise training alone in non-sprint-trained individuals. A longer trial period may be required to evaluate effect on recovery more conclusively. In addition, the prime importance of physical conditioning, and in particular task-specific exercise training, in stimulating performance and recovery adaptations is highlighted. South African Journal of Sports Medicine Vol. 18 (4) 2006: pp. 136-140
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Vanezis, Andrew Peter, Jayanth Ranjit Arnold, Glenn Rodrigo, Florence Y. Lai, Radek Debiec, Sheraz Nazir, Jamal Nasir Khan, et al. "Daily remote ischaemic conditioning following acute myocardial infarction: a randomised controlled trial." Heart 104, no. 23 (May 10, 2018): 1955–62. http://dx.doi.org/10.1136/heartjnl-2018-313091.
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BackgroundRemote ischaemic conditioning (rIC) is a cardioprotective tool which has shown promise in preclinical and clinical trials in the context of acute ischaemia. Repeated rIC post myocardial infarction may provide additional benefits which have not previously been tested clinically.MethodsThe trial assessed the role of daily rIC in enhancing left ventricular ejection fraction (LVEF) recovery in patients with impaired LVEF (<45%) after ST segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (P-PCI). Patients were recruited from four UK hospitals and randomised to receive either 4 weeks of daily rIC or sham conditioning using the autoRIC Device (CellAegis) starting on day 3 post P-PCI. The primary endpoint was the improvement in LVEF over 4 months assessed by cardiac MRI (CMR). Seventy-three patients (38 cases, 35 controls) completed the study.ResultsThe treatment and control groups were well matched at baseline including for mean LVEF (42.8% vs 44.3% respectively, p=0.952). There was no difference in the improvement in LVEF over 4 months between the treatment and control groups (4.8%±7.8% vs 4.6%±5.9% respectively, p=0.924). No differences were seen in the secondary outcome measures including changes in infarct size and left ventricular end-diastolic and systolic volumes, major adverse cardiac and cerebral event, mean Kansas City Cardiomyopathy Questionnaire score and change in N-terminal pro-brain natriuretic peptide levels.ConclusionsDaily rIC starting on day 3 and continued for 4 weeks following successful P-PCI for STEMI did not improve LVEF as assessed by CMR after 4 months when compared with a matched control group.Trial registration numberNCT0166461.
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Davidson, Kate M., Peter Tyrer, John Norrie, Stephen J. Palmer, and Helen Tyrer. "Cognitive therapy v. usual treatment for borderline personality disorder: prospective 6-year follow-up." British Journal of Psychiatry 197, no. 6 (December 2010): 456–62. http://dx.doi.org/10.1192/bjp.bp.109.074286.
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BackgroundLonger-term follow-up of patients with borderline personality disorder have found favourable clinical outcomes, with long-term reduction in symptoms and diagnosis.AimsWe examined the 6-year outcome of patients with borderline personality disorder who were randomised to 1 year of cognitive–behavioural therapy for personality disorders (CBT–PD) or treatment as usual (TAU) in the BOSCOT trial, in three centres across the UK (trial registration: ISRCTN86177428).MethodIn total, 106 participants met criteria for borderline personality disorder in the original trial. Patients were interviewed at follow-up by research assistants masked to the patient's original treatment group, CBT–PD or TAU, using the same measures as in the original randomised trial. Statistical analyses of data for the group as a whole are based on generalised linear models with repeated measures analysis of variance type models to examine group differences.ResultsFollow-up data were obtained for 82% of patients at 6 years. Over half the patients meeting criteria for borderline personality disorder at entry into the study no longer did so 6 years later. The gains of CBT–PD over TAU in reduction of suicidal behaviour seen after 1-year follow-up were maintained. Length of hospitalisation and cost of services were lower in the CBT–PD group compared with the TAU group.ConclusionsAlthough the use of CBT–PD did not demonstrate a statistically significant cost-effective advantage, the findings indicate the potential for continued long-term cost-offsets that accrue following the initial provision of 1 year of CBT–PD. However, the quality of life and affective disturbance remained poor.
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Conaghan, Philip G., Mikkel Østergaard, Michael A. Bowes, Chunying Wu, Thomas Fuerst, Désirée van der Heijde, Fedra Irazoque-Palazuelos, et al. "Comparing the effects of tofacitinib, methotrexate and the combination, on bone marrow oedema, synovitis and bone erosion in methotrexate-naive, early active rheumatoid arthritis: results of an exploratory randomised MRI study incorporating semiquantitative and quantitative techniques." Annals of the Rheumatic Diseases 75, no. 6 (January 25, 2016): 1024–33. http://dx.doi.org/10.1136/annrheumdis-2015-208267.
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ObjectivesTo explore the effects of tofacitinib—an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA)—with or without methotrexate (MTX), on MRI endpoints in MTX-naive adult patients with early active RA and synovitis in an index wrist or hand.MethodsIn this exploratory, phase 2, randomised, double-blind, parallel-group study, patients received tofacitinib 10 mg twice daily + MTX, tofacitinib 10 mg twice daily + placebo (tofacitinib monotherapy), or MTX + placebo (MTX monotherapy), for 1 year. MRI endpoints (Outcome Measures in Rheumatology Clinical Trials RA MRI score (RAMRIS), quantitative RAMRIS (RAMRIQ) and dynamic contrast-enhanced (DCE) MRI) were assessed using a mixed-effect model for repeated measures. Treatment differences with p<0.05 (vs MTX monotherapy) were considered significant.ResultsIn total, 109 patients were randomised and treated. Treatment differences in RAMRIS bone marrow oedema (BME) at month 6 were −1.55 (90% CI −2.52 to −0.58) for tofacitinib + MTX and −1.74 (−2.72 to −0.76) for tofacitinib monotherapy (both p<0.01 vs MTX monotherapy). Numerical improvements in RAMRIS synovitis at month 3 were −0.63 (−1.58 to 0.31) for tofacitinib + MTX and −0.52 (−1.46 to 0.41) for tofacitinib monotherapy (both p>0.05 vs MTX monotherapy). Treatment differences in RAMRIQ synovitis were statistically significant at month 3, consistent with DCE MRI findings. Less deterioration of RAMRIS and RAMRIQ erosive damage was seen at months 6 and 12 in both tofacitinib groups versus MTX monotherapy.ConclusionsThese results provide consistent evidence using three different MRI technologies that tofacitinib treatment leads to early reduction of inflammation and inhibits progression of structural damage.Trial registration numberNCT01164579.
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Boterhoven de Haan, Katrina L., Christopher W. Lee, Eva Fassbinder, Saskia M. van Es, Simone Menninga, Marie-Louise Meewisse, Marleen Rijkeboer, Margriet Kousemaker, and Arnoud Arntz. "Imagery rescripting and eye movement desensitisation and reprocessing as treatment for adults with post-traumatic stress disorder from childhood trauma: randomised clinical trial." British Journal of Psychiatry 217, no. 5 (September 7, 2020): 609–15. http://dx.doi.org/10.1192/bjp.2020.158.
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BackgroundInvestigation of treatments that effectively treat adults with post-traumatic stress disorder from childhood experiences (Ch-PTSD) and are well tolerated by patients is needed to improve outcomes for this population.AimsThe purpose of this study was to compare the effectiveness of two trauma-focused treatments, imagery rescripting (ImRs) and eye movement desensitisation and reprocessing (EMDR), for treating Ch-PTSD.MethodWe conducted an international, multicentre, randomised clinical trial, recruiting adults with Ch-PTSD from childhood trauma before 16 years of age. Participants were randomised to treatment condition and assessed by blind raters at multiple time points. Participants received up to 12 90-min sessions of either ImRs or EMDR, biweekly.ResultsA total of 155 participants were included in the final intent-to-treat analysis. Drop-out rates were low, at 7.7%. A generalised linear mixed model of repeated measures showed that observer-rated post-traumatic stress disorder (PTSD) symptoms significantly decreased for both ImRs (d = 1.72) and EMDR (d = 1.73) at the 8-week post-treatment assessment. Similar results were seen with secondary outcome measures and self-reported PTSD symptoms. There were no significant differences between the two treatments on any standardised measure at post-treatment and follow-up.ConclusionsImRs and EMDR treatments were found to be effective in treating PTSD symptoms arising from childhood trauma, and in reducing other symptoms such as depression, dissociation and trauma-related cognitions. The low drop-out rates suggest that the treatments were well tolerated by participants. The results from this study provide evidence for the use of trauma-focused treatments for Ch-PTSD.
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Stapleton, Peta, Terri Sheldon, Brett Porter, and Jennifer Whitty. "A Randomised Clinical Trial of a Meridian-Based Intervention for Food Cravings With Six-Month Follow-Up." Behaviour Change 28, no. 1 (May 1, 2011): 1–16. http://dx.doi.org/10.1375/bech.28.1.1.
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AbstractThis randomised, clinical trial tested whether The Emotional Freedom Technique (EFT) reduced food cravings. This study involved 96 overweight or obese adults who were allocated to the EFT treatment or 4-week waitlist condition. Degree of food craving, perceived power of food, restraint capabilities and psychological symptoms were assessed pre- and post- a 4-week treatment program (mixed method ANOVA comparative analysis), and at 6-month follow-up (repeated measure ANOVA with group data collapsed). EFT was associated with a significantly greater improvement in food cravings, the subjective power of food and craving restraint than waitlist from pre- to immediately post-test (p< .05). Across collapsed groups, an improvement in food cravings and the subjective power of food after active EFT treatment was maintained at 6 months, and a delayed effect was seen for craving restraint. Although there was a significant reduction in measures of psychological distress immediately after treatment (p< .05), there was no between-group difference. These findings are consistent with the hypothesis that EFT can have an immediate effect on reducing food cravings and can result in maintaining reduced cravings over time.
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Barre, D. E., K. A. Mizier-Barre, E. Stelmach, J. Hobson, O. Griscti, A. Rudiuk, and D. Muthuthevar. "Flaxseed Lignan Complex Administration in Older Human Type 2 Diabetics Manages Central Obesity and Prothrombosis—An Invitation to Further Investigation into Polypharmacy Reduction." Journal of Nutrition and Metabolism 2012 (2012): 1–7. http://dx.doi.org/10.1155/2012/585170.
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Aim. Animal and human study evidence supports the hypothesis that flaxseed lignan complex (FLC) at a dose of 600 mg secoisolariciresinol diglucoside (SDG)/day for three months would combat hyperglycaemia, dyslipidemia, blood pressure, central obesity, prothrombotic state, inflammation, and low density lipoprotein (LDL) oxidation.Methods. Sixteen type 2 diabetic patients completed this double-blind, randomised crossover placebo-controlled study. A univariate repeated measures analysis of covariance (significanceP<0.05) was followed by a mixed linear model effects analysis corrected for multiple comparisons (MCC).Results. Prior to MCC, FLC caused decreased fasting plasma glucose, A1c, inflammation (c-reactive protein (CRP) and interleukin-6 (IL-6)), and increased bleeding time. After correction for multiple comparisons, FLC induced a statistically significant increase in bleeding time and smaller waist circumference gain. No treatment effect occurred in the other variables before or after adjustment.Conclusions. It is concluded that FLC significantly increased bleeding time thus reducing the prothrombotic state, reduced central obesity gain as measured by waist circumference, and did not affect significantly the other dependent variables measured after adjustment for multiple comparisons. These findings, not yet published in human type 2 diabetes, suggest that this FLC dose over at least three months, may, subject to further investigation, reduce polypharmacy.
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Dean, Olivia M., Buranee Kanchanatawan, Melanie Ashton, Mohammadreza Mohebbi, Chee Hong Ng, Michael Maes, Lesley Berk, et al. "Adjunctive minocycline treatment for major depressive disorder: A proof of concept trial." Australian & New Zealand Journal of Psychiatry 51, no. 8 (June 3, 2017): 829–40. http://dx.doi.org/10.1177/0004867417709357.
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Objective: Conventional antidepressant treatments result in symptom remission in 30% of those treated for major depressive disorder, raising the need for effective adjunctive therapies. Inflammation has an established role in the pathophysiology of major depressive disorder, and minocycline has been shown to modify the immune-inflammatory processes and also reduce oxidative stress and promote neuronal growth. This double-blind, randomised, placebo-controlled trial examined adjunctive minocycline (200 mg/day, in addition to treatment as usual) for major depressive disorder. This double-blind, randomised, placebo-controlled trial investigated 200 mg/day adjunctive minocycline (in addition to treatment as usual) for major depressive disorder. Methods: A total of 71 adults with major depressive disorder ( Diagnostic and Statistical Manual of Mental Disorders–Fourth Edition) were randomised to this 12-week trial. Outcome measures included the Montgomery–Asberg Depression Rating Scale (primary outcome), Clinical Global Impression–Improvement and Clinical Global Impression–Severity, Hamilton Anxiety Rating Scale, Quality of Life Enjoyment and Satisfaction Questionnaire, Social and Occupational Functioning Scale and the Range of Impaired Functioning Tool. The study was registered on the Australian and New Zealand Clinical Trials Register: www.anzctr.org.au , #ACTRN12612000283875. Results: Based on mixed-methods repeated measures analysis of variance at week 12, there was no significant difference in Montgomery–Asberg Depression Rating Scale scores between groups. However, there were significant differences, favouring the minocycline group at week 12 for Clinical Global Impression–Improvement score – effect size (95% confidence interval) = −0.62 [−1.8, −0.3], p = 0.02; Quality of Life Enjoyment and Satisfaction Questionnaire score – effect size (confidence interval) = −0.12 [0.0, 0.2], p < 0.001; and Social and Occupational Functioning Scale and the Range of Impaired Functioning Tool score – 0.79 [−4.5, −1.4], p < 0.001. These effects remained at follow-up (week 16), and Patient Global Impression also became significant, effect size (confidence interval) = 0.57 [−1.7, −0.4], p = 0.017. Conclusion: While the primary outcome was not significant, the improvements in other comprehensive clinical measures suggest that minocycline may be a useful adjunct to improve global experience, functioning and quality of life in people with major depressive disorder. Further studies are warranted to confirm the potential of this accessible agent to optimise treatment outcomes.
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Hogan, Neasa, Maria Kehoe, Aidan Larkin, and Susan Coote. "The Effect of Community Exercise Interventions for People with MS Who Use Bilateral Support for Gait." Multiple Sclerosis International 2014 (2014): 1–8. http://dx.doi.org/10.1155/2014/109142.
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Background. Mobility limitations are a key feature of MS and 25% will require the use of a walking aid 15 years after diagnosis. Few studies have specifically evaluated the effectiveness of physiotherapy and exercise interventions delivered in the community for those with significant disability.Methods. An assessor blind, block randomised, and controlled study recruited participants who required bilateral assistance for gait and who occasionally used wheelchairs for longer distances. They were randomised to 10 weeks of group physiotherapy (balance and strengthening exercises), individual physiotherapy, yoga group, or a control group.Results. Repeated measures ANOVA found significant time effects for physical component of MSIS-29v2 (f=7.993,P=0.006) and MFIS (f=8.695,P=0.004). The group × time interaction was significant for the BBS (f=4.391,P=0.006). Post hoc analysis revealed no difference between group and individual physiotherapy for BBS. There was no significant difference between groups but the 6MWT improved for individual physiotherapy (P=0.001) and MSIS-29v2 psychological score for group physiotherapy (P=0.005).Discussion. This study found that balance and strengthening exercises, delivered in the community to those with significant mobility limitations, improve balance. The effect on walking endurance and patient-reported outcomes are unclear and warrants further investigation with a larger control group with similar baseline characteristics to the intervention groups.
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Kock, Merle, Eline Van Hoecke, Filip Raes, and Katleen Van der Gucht. "Study protocol for You.Mind!: boosting first-line mental health care for YOUngsters suffering from chronic conditions with mindfulness: a randomised staggered within-subjects design." BMJ Open 11, no. 4 (April 2021): e042648. http://dx.doi.org/10.1136/bmjopen-2020-042648.
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IntroductionAdolescents with chronic conditions often experience high levels of stress, anxiety and depression, and reduced quality of life. Mindfulness-based interventions (MBIs) have been found to improve emotional distress in clinical and non-clinical populations and are a promising technique to support adolescents with chronic conditions in managing their symptoms and ultimately enhance their quality of life.Methods and analysisTo test the effects of an MBI on emotional distress and quality of life and delineate the underlying mechanisms, the You.Mind! study uses a randomised staggered within-subjects design. Thirty adolescents with a chronic condition will be randomised to a baseline phase of 14–28 days followed by an MBI, consisting of four online group sessions and online support spread over 8 weeks. Outcomes will be assessed by short, repeated measurements throughout the baseline, intervention and follow-up phases and by standardised questionnaires and experience sampling measures before randomisation, at postintervention and at 3-months follow-up. Analysis will be based on general linear modelling and multilevel mixed-effects modelling.Ethics and disseminationEthical approval was obtained from the Ethics Committee Research UZ/KU Leuven and the Ethics Committee of Ghent University Hospital and Ghent University (S63485). Results will be disseminated through presentations at public lectures, scientific institutions and meetings, and through publication in peer-reviewed journals.Trial registration numberNCT04359563.
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Patterson, Kacie, Rachel Davey, Richard Keegan, Theophile Niyonsenga, Itismita Mohanty, Sander van Berlo, and Nicole Freene. "A smartphone app for sedentary behaviour change in cardiac rehabilitation and the effect on hospital admissions: the ToDo-CR randomised controlled trial study protocol." BMJ Open 10, no. 12 (December 2020): e040479. http://dx.doi.org/10.1136/bmjopen-2020-040479.
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IntroductionCardiac rehabilitation (CR) is recommended for secondary prevention of cardiovascular disease and reducing the risk of repeat cardiac events. Physical activity is a core component of CR; however, studies show that participants remain largely sedentary. Sedentary behaviour is an independent risk factor for all-cause mortality. Strategies to encourage sedentary behaviour change are needed. This study will explore the effectiveness and costs of a smartphone application (Vire) and an individualised online behaviour change program (ToDo-CR) in reducing sedentary behaviour, all-cause hospital admissions and emergency department visits over 12 months after commencing CR.Methods and analysisA multicentre, assessor-blind parallel randomised controlled trial will be conducted with 144 participants (18+ years). Participants will be recruited from three phase-II CR centres. They will be assessed on admission to CR and randomly assigned (1:1) to one of two groups: CR plus the ToDo-CR 6-month programme or usual care CR. Both groups will be re-assessed at 6 months and 12 months for the primary outcome of all-cause hospital admissions and presentations to the emergency department. Accelerometer-measured changes in sedentary behaviour and physical activity will also be assessed. Logistic regression models will be used for the primary outcome of hospital admissions and emergency department visits. Methods for repeated measures analysis will be used for all other outcomes. A cost-effectiveness analysis will be conducted to evaluate the effects of the intervention on the rates of hospital admissions and emergency department visits within the 12 months post commencing CR.Ethics and disseminationThis study received ethical approval from the Australian Capital Territory Health (2019.ETH.00162), Calvary Public Hospital Bruce (20–2019) and the University of Canberra (HREC-2325) Human Research Ethics Committees (HREC). Results will be disseminated through peer-reviewed academic journals. Results will be made available to participants on request.Trial registration numberACTRN12619001223123.
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Smink, Gayle M., Donna B. Jeffe, Robert J. Hayashi, Noor Al-Hammadi, and James J. Fehr. "Paediatric oncology simulation training for resident education." BMJ Simulation and Technology Enhanced Learning 5, no. 3 (September 7, 2018): 155–60. http://dx.doi.org/10.1136/bmjstel-2018-000347.
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IntroductionWe sought to evaluate paediatric oncology simulations intended to improve paediatric residents’ skills and comfort in caring for children with cancer.MethodIn a non-randomised trial, controls (the first three rotations) received a standard set of lectures, and the intervention arm received these lectures plus five simulation training scenarios—fever/neutropaenia, a new leukaemia diagnosis, end-of-life care discussion, tumour lysis syndrome and a mediastinal mass. All residents were tested after the rotation on the first three scenarios; management skills were evaluated independently by two raters. Before and after training, all residents completed an emotional-appraisal questionnaire evaluating each scenario as a perceived challenge or threat. Analysis of variance (ANOVA) measured differences by study arm in skills checklist assessments and appraisals; repeated measures ANOVA measured changes in emotional-appraisal scores.ResultsForty-two residents (9 controls, 33 interventions) participated. Inter-rater agreement for skills checklist scores using average-measures intraclass correlation was high (0.847), and overall mean scores were significantly higher for the intervention than control group across both raters (p=0.005). For all residents, perceived challenge increased in the end-of-life simulation, and perceived threat decreased in all three test scenarios. The intervention group, regardless of training year, evaluated the teaching scenarios favourably and felt that challenging oncology situations were addressed, skills were enhanced and the simulations should be offered to other residents.ConclusionsIt was feasible to introduce residents to difficult paediatric oncology scenarios using simulation. The intervention group performed more skills than controls when tested and perceive threat declined in all residents after their paediatric oncology rotation.
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Hodgson, Janet, Skye McDonald, Robyn Tate, and Paul Gertler. "A Randomised Controlled Trial of a Cognitive-Behavioural Therapy Program for Managing Social Anxiety After Acquired Brain Injury." Brain Impairment 6, no. 3 (December 1, 2005): 169–80. http://dx.doi.org/10.1375/brim.2005.6.3.169.
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AbstractDespite the prevalence of psychiatric illness in people with acquired brain injury (ABI), there are very few empirically validated studies examining the efficacy of treatments targeting commonly occurring disorders such as depression and anxiety. Using a randomised controlled trial, this study evaluated the efficacy of a cognitive behavioural intervention specifically designed for managing social anxiety following ABI. Twelve brain-injured participants were screened, randomly allocated to either treatment group (TG) or a wait list group (WLG), and proceeded through to the final stages of therapy. The TG received between 9 and 14 hourly, individual sessions of cognitive behavioural therapy. Repeated measures analyses revealed significant improvements in general anxiety, depression and a transient mood measure, tension-anxiety, for the TG when compared to the WLG at posttreatment. These treatment gains were maintained at one-month follow-up. Although in the predicted direction, postintervention improvements in social anxiety and self-esteem for the TG were not significant in comparison with the WLG. This study lends support to the small body of literature highlighting the potential of cognitive behavioural interventions for managing the psychological problems that serve as a barrier to rehabilitation following ABI.
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Micha, Renata, Peter J. Rogers, and Michael Nelson. "Glycaemic index and glycaemic load of breakfast predict cognitive function and mood in school children: a randomised controlled trial." British Journal of Nutrition 106, no. 10 (June 8, 2011): 1552–61. http://dx.doi.org/10.1017/s0007114511002303.
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The macronutrient composition of a breakfast that could facilitate performance after an overnight fast remains unclear. As glucose is the brain's major energy source, the interest is in investigating meals differing in their blood glucose-raising potential. Findings vary due to unaccounted differences in glucoregulation, arousal and cortisol secretion. We investigated the effects of meals differing in glycaemic index (GI) and glycaemic load (GL) on cognition and mood in school children. A total of seventy-four school children were matched and randomly allocated either to the high-GL or low-GL group. Within each GL group, children received high-GI and low-GI breakfasts. Cognitive function (CF) and mood were measured 95–140 min after breakfast. Blood glucose and salivary cortisol were measured at baseline, before and after the CF tests. Repeated-measures ANOVA was used to identify differences in CF, mood, glucose and cortisol levels between the breakfasts. Low-GI meals predicted feeling more alert and happy, and less nervous and thirsty (P < 0·05 for each); high-GL meals predicted feeling more confident, and less sluggish, hungry and thirsty (P < 0·05 for each). High-GL (P < 0·001) and high-GI (P = 0·05) meals increased glucose levels 90 min after breakfast, and high-GI meals increased cortisol levels (P < 0·01). When baseline mood, glucose and cortisol levels were considered, low-GI meals predicted better declarative-verbal memory (P = 0·03), and high-GI meals better vigilance (P < 0·03); observed GI effects were valid across GL groups. GI effects on cognition appear to be domain specific. On balance, it would appear that the low-GI high-GL breakfast may help to improve learning, and of potential value in informing government education policies relating to dietary recommendations and implementation concerning breakfast.
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Milési, Christophe, Julien Baleine, Thibault Mura, Fernando Benito-Castro, Félicie Ferragu, Gérard Thiriez, Pierre Thévenot, Clémentine Combes, Ricardo Carbajal, and Gilles Cambonie. "Nasal midazolam vs ketamine for neonatal intubation in the delivery room: a randomised trial." Archives of Disease in Childhood - Fetal and Neonatal Edition 103, no. 3 (August 17, 2017): F221—F226. http://dx.doi.org/10.1136/archdischild-2017-312808.
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ObjectiveTo compare the effectiveness of sedation by intranasal administration of midazolam (nMDZ) or ketamine (nKTM) for neonatal intubation.DesignA multicentre, prospective, randomised, double-blind study.SettingDelivery rooms at four tertiary perinatal centres in France.PatientsPreterm neonates with respiratory distress requiring non-emergent endotracheal intubation for surfactant instillation.InterventionsTreatment was randomly allocated, with each neonate receiving a bolus of 0.1 mL/kg in each nostril, corresponding to 0.2 mg/kg for nMDZ and 2 mg/kg for nKTM. The drug was repeated once 7 min later at the same dose if adequate sedation was not obtained.Main outcome measuresSuccess was defined by adequate sedation before intubation and adequate comfort during the procedure. Intubation features, respiratory and cardiovascular events were recorded.ResultsSixty newborns, with mean (SD) gestational age and birth weight of 28 (3) weeks and 1100 (350) g, were included within the first 20 min of life. nMDZ was associated with a higher success rate (89% vs 58%; RR: 1.54, 95% CI 1.12 to 2.12, p<0.01) and shorter delays between the first dose and intubation (10 (6) vs 16 (8) min, p<0.01).Number of attempts, time to intubation, mean arterial blood pressure measures over the first 12 hours after birth and length of invasive ventilation were not different.ConclusionsnMDZ was more efficient than nKTM to adequately sedate neonates requiring intubation in the delivery room. The haemodynamic and respiratory effects of both drugs were comparable.Clinical trialThis clinical trial was recorded on the National Library of Medicine registry (NCT01517828).
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Pellegrino, Jeffrey L., David Bogumil, Jonathan L. Epstein, and Rita V. Burke. "Two-thumb-encircling advantageous for lay responder infant CPR: a randomised manikin study." Archives of Disease in Childhood 104, no. 6 (July 14, 2018): 530–34. http://dx.doi.org/10.1136/archdischild-2018-314893.
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ObjectivePaediatric health providers and educators influence infant mortality through advocacy and training within families and communities. This research sought to establish the efficacy and training of two-finger versus two-thumb-encircling techniques for lone responder infant chest compressions with ventilations in initially trained infant caregivers.DesignThis is a randomised, cross-over educational intervention assessed on instrumented manikins using the 2015 guideline measures of quality infant cardiopulmonary resuscitation (CPR). Additional subjective data on the experience were collected through self-reporting.SettingNon-healthcare community organisations and secondary school classrooms.ParticipantsFourteen years or older, fluent in English and had not taken infant CPR in the last 5 years.InterventionsGroups of eight participants were randomised to learn one technique, practised and then tested for 8 min. After a 30 min rest, the group repeated the process using the other technique.Main outcome measuresMean chest compression depth and rate, compression fraction, and correct hand position; tiredness and pain as reported by the caregiver.ResultsThe two-thumb-encircling technique achieved a deeper mean compression depth over the 8 min period (2.0 mm, p<0.01), closer to the minimum recommendation of 40 mm; the two-finger technique achieved higher percentages of compression fraction and complete recoil. Caregivers preferred the two-thumb technique (64%), and of these 70% had long fingernails.ConclusionsThe two-thumb-encircling technique improved compression depth, over an 8 min scenario, and was preferred by caregivers. This adds to the existing literature on the advantages of two-thumb-encircling as a technique for lone and team infant CPR, which counters current guidelines.
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McEvoy, Cindy T., Lyndsey E. Shorey-Kendrick, Kristin Milner, Diane Schilling, Christina Tiller, Brittany Vuylsteke, Ashley Scherman, et al. "Vitamin C to pregnant smokers persistently improves infant airway function to 12 months of age: a randomised trial." European Respiratory Journal 56, no. 6 (July 2, 2020): 1902208. http://dx.doi.org/10.1183/13993003.02208-2019.
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BackgroundVitamin C (500 mg·day−1) supplementation for pregnant smokers has been reported to increase newborn pulmonary function and infant forced expiratory flows (FEFs) at 3 months of age. Its effect on airway function through 12 months of age has not been reported.ObjectiveTo assess whether vitamin C supplementation to pregnant smokers is associated with a sustained increased airway function in their infants through 12 months of age.MethodsThis is a pre-specified secondary outcome of a randomised, double-blind, placebo-controlled trial that randomised 251 pregnant smokers between 13 and 23 weeks of gestation: 125 to 500 mg·day−1 vitamin C and 126 to placebo. Smoking cessation counselling was provided. FEFs performed at 3 and 12 months of age were analysed by repeated-measures analysis of covariance.ResultsFEFs were performed in 222 infants at 3 months and 202 infants at 12 months of age. The infants allocated to vitamin C had significantly increased FEFs over the first year of life compared to those allocated to placebo. The overall increased flows were 40.2 mL·s−1 for at FEF75 (75% of forced vital capacity (FVC)) (adjusted 95% CI for difference 6.6–73.8; p=0.025); 58.3 mL·s−1 for FEF50 (10.9–105.8; p=0.0081); and 55.1 mL·s−1 for FEF25–75 (9.7–100.5; p=0.013).ConclusionsIn offspring of pregnant smokers randomised to vitamin C versus placebo, vitamin C during pregnancy was associated with a small but significantly increased airway function at 3 and 12 months of age, suggesting a potential shift to a higher airway function trajectory curve. Continued follow-up is underway.
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Leyh, Samantha M., Brandon D. Willingham, Daniel A. Baur, Lynn B. Panton, and Michael J. Ormsbee. "Pre-sleep protein in casein supplement or whole-food form has no impact on resting energy expenditure or hunger in women." British Journal of Nutrition 120, no. 9 (September 25, 2018): 988–94. http://dx.doi.org/10.1017/s0007114518002416.
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AbstractThe purpose of this study was to determine the effect of a whole-food protein (cottage cheese, CC) consumed before sleep on next-morning resting energy expenditure (REE), RER and appetite compared with an isoenergetic/isonitrogenous casein protein (CP) supplement and placebo (PL) in active women. In a beverage-blinded, randomised, cross-over design, ten active women (age, 23·1 (sd 1·9) years; body fat, 22·0 (sd 4·6) %) consumed pre-sleep CC (30 g of protein, 10 g of carbohydrate and 0 g of fat) or energy- and protein-matched liquid CP or PL (0 kJ). Participants arrived at 18.00 hours for an overnight stay in the laboratory. At 30–60 min before normal bed time (2 h post standard meal), participants consumed CC, CP or PL before measurement of REE. Upon waking (05.00–08.00 hours), REE was repeated and subjective appetite was recorded. Statistical analyses were conducted using repeated-measures ANOVA (SPSS). Significance was accepted at P≤0·05. There were no significant differences in acute REE (CC, 7217 (sd 1368); CP, 7188 (SD 895); PL, 7075 (sd 1108) kJ/d, P=0·95), acute RER (0·79 (sd 0·05), P=0·56), morning REE (CC, 5840 (sd 1225); CP, 5694 (sd 732); PL, 5991 (sd 903) kJ/d, P=0·79) or morning RER (0·77 (sd 0·03), P=0·52). Subjective measures of appetite were not different between groups. In active women, pre-sleep consumption of CC does not alter REE or RER more than a CP or PL beverage. These data suggest that the metabolic response from whole-food protein do not differ from the metabolic response of liquid protein.
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Chamberlain, Chris, Peter J. Colman, Ann M. Ranger, Linda C. Burkly, Geoffrey I. Johnston, Christian Otoul, Christian Stach, et al. "Repeated administration of dapirolizumab pegol in a randomised phase I study is well tolerated and accompanied by improvements in several composite measures of systemic lupus erythematosus disease activity and changes in whole blood transcriptomic profiles." Annals of the Rheumatic Diseases 76, no. 11 (August 5, 2017): 1837–44. http://dx.doi.org/10.1136/annrheumdis-2017-211388.
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ObjectivesSystemic lupus erythematosus (SLE) is a heterogeneous autoimmune disease associated with diffuse immune cell dysfunction. CD40–CD40 ligand (CD40L) interaction activates B cells, antigen-presenting cells and platelets. CD40L blockade might provide an innovative treatment for systemic autoimmune disorders. We investigated the safety and clinical activity of dapirolizumab pegol, a polyethylene glycol conjugated anti-CD40L Fab' fragment, in patients with SLE.MethodsThis 32-week randomised, double-blind, multicentre study (NCT01764594) evaluated repeated intravenous administration of dapirolizumab pegol in patients with SLE who were positive for/had history of antidouble stranded DNA/antinuclear antibodies and were on stable doses of immunomodulatory therapies (if applicable). Sixteen patients were randomised to 30 mg/kg dapirolizumab pegol followed by 15 mg/kg every 2 weeks for 10 weeks; eight patients received a matched placebo regimen. Randomisation was stratified by evidence of antiphospholipid antibodies. Patients were followed for 18 weeks after the final dose.ResultsNo serious treatment-emergent adverse events, thromboembolic events or deaths occurred. Adverse events were mild or moderate, transient and resolved without intervention. One patient withdrew due to infection.Efficacy assessments were conducted only in patients with high disease activity at baseline. Five of 11 (46%) dapirolizumab pegol-treated patients achieved British Isles Lupus Assessment Group-based Composite Lupus Assessment response (vs 1/7; 14% placebo) and 5/12 (42%) evaluable for SLE Responder Index-4 responded by week 12 (vs 1/7; 14% placebo). Mechanism-related gene expression changes were observed in blood RNA samples.ConclusionsDapirolizumab pegol could be an effective biological treatment for SLE. Further studies are required to address efficacy and safety.Trial registration numberNCT01764594.