scholarly journals Hands-Up program: protocol for a feasibility randomised controlled trial of a combined 6-week exercise and education intervention in adults aged 50–65 with a distal radius fracture

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e046122
Author(s):  
Christina Ziebart ◽  
Joy MacDermid ◽  
Dianne Bryant ◽  
Mike Szekeres ◽  
Nina Suh
Keyword(s):  
Randomised Controlled Trial ◽  
Distal Radius Fracture ◽  
Distal Radius ◽  
Education Program ◽  
Controlled Trial ◽  
Self Report ◽  
Radius Fracture ◽  
Secondary Outcome ◽  
Home Exercise ◽  
Randomised Controlled

IntroductionThis pilot study will determine the feasibility of recruitment, retention and adherence for the online combined exercise and education programme (Hands-Up) compared with usual care.Methods and analysisThe proposed randomised controlled trial will be a pilot feasibility study with a 1:1 randomisation to the Hands-Up programme or usual physical therapy. The programme setting is an online home exercise and education program. Outcome assessments will take place at the Roth|McFarlane Hand and Upper Limb Clinic in London, Ontario, which is a tertiary care academic centre. 74 people aged 50–65 years after distal radius fracture will be recruited. Purposeful recruitment will be conducted to include a sufficient number of men in the study. The Hands-Up program includes both exercise and education. Participants will engage in approximately 45 min of a full-body home exercise routine followed by 30 min of education in an online program. The educational modules will focus on fall prevention, nutrition for osteoporosis and learning about osteoporosis. Participants will engage in the program online, twice a week for 6 weeks. Outcomes will be assessed at baseline, 6 weeks and 3, 6 and 12 months. The primary outcome of the study is feasibility. The study will be considered feasible if participants attend >60% of the sessions, 74 participants are enrolled in 12 months and >75% of participants attend the final study visit. For the secondary outcome, physical and self-report outcomes will be assessed.Ethics and discussionThis study has been approved by the institutional ethics review board. The viability of an online exercise and education program for people after distal radius fracture between the ages of 50 and 65 will be evaluated in an attempt to help better prevent, diagnose and manage osteoporosis. This study will be disseminated through peer-reviewed publications, international conferences and social media.Trial registration numberNCT03997682.

scholarly journals Exercise and education for community-dwelling older participants with knee osteoarthritis: a video-linked programme protocol based on a randomised controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lin Wang ◽  
Suhang Xie ◽  
Tianjie Bao ◽  
Siyi Zhu ◽  
Qiu Liang ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Knee Osteoarthritis ◽  
Rating Scale ◽  
Controlled Trial ◽  
Pressure Pain Threshold ◽  
Estimating Equation ◽  
Community Dwelling ◽  
Self Report ◽  
Exercise Programmes ◽  
Randomised Controlled

Abstract Background Neuromuscular and quadriceps exercises have been shown to be effective approaches to relieve pain and to improve function for patients with knee osteoarthritis. In this study, we aim to provide an informative feasible model in which therapeutic exercise and education will be undertaken with physiotherapy supervision and instruction via video link. We also aim to explore the relationship between program-induced pain alleviation/functional improvements and reduction in irritability, which might be mediated through program-induced psychosocial benefits. Methods In this proposed two-parallel group (neuromuscular exercise versus quadriceps exercise), single-blinded, randomised controlled trial, participants aged ≥50 years with osteoarthritic knee pain will undergo a 12-week intervention, comprising video-linked education, supervised exercises, and a 12-week follow-up. Seven measurements will be taken to collect longitudinal data. A generalised estimating equation will be used to establish the adjusted difference in effectiveness on pain, function, irritability, and psychosocial outcomes between participants undertaking neuromuscular exercises and those undertaking quadriceps exercises. The primary outcomes are overall average pain in the knee joint during walking, as assessed through the 11-point Numerical Pain Rating Scale, and the Western Ontario and McMaster Universities osteoarthritis index physical function subscale. Furthermore, pressure pain threshold and changes in self-report pain scores pre-, during, and post-exercise were also measured as an indication of irritability. In addition, both the 6-min walk test and a timed up & go test were used to assess walking function performance. Finally, patients’ emotions (e.g., fear and catastrophising), self-trust, needs in terms of disease knowledge, mental resilience, social support and health-related quality of life were investigated. Two four-wave cross-lagged models will be used to investigate directional relationships, aiming to investigate the complex mechanisms concerning the effects of exercise programmes. Discussion Through summarising the study’s strengths and limitations, this study may provide promising insights in terms of exercise therapy optimisation for people with knee osteoarthritis and/or other chronic pain within a psychosocial framework. Trial registration ChiCTR2100041978 (chictr.org.cn), January 10, 2021.

scholarly journals PEP-CoV protocol: a PEP flute-self-care randomised controlled trial to prevent respiratory deterioration and hospitalisation in early COVID-19

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e050582
Author(s):  
Annette Mollerup ◽  
Sofus Christian Larsen ◽  
Anita Selmer Bennetzen ◽  
Marius Henriksen ◽  
Mette Kildevaeld Simonsen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Hospital Admission ◽  
Usual Care ◽  
Pulmonary Disease ◽  
Controlled Trial ◽  
Self Care ◽  
Secondary Outcome ◽  
Link Type ◽  
Randomised Controlled ◽  
At Home

IntroductionInfection with SARS-CoV-2 may progress to severe pulmonary disease, COVID-19. Currently, patients admitted to hospital because of COVID-19 have better prognosis than during the first period of the pandemic due to improved treatment. However, the overall societal susceptibility of being infected makes it pivotal to prevent severe courses of disease to avoid high mortality rates and collapse of the healthcare systems. Positive expiratory pressure (PEP) self-care is used in chronic pulmonary disease and has been shown to prevent pneumonia in a high-risk cohort of patients with leukaemia. PEP flute self-care to prevent respiratory deterioration and hospitalisation in early COVID-19: a randomised trial (The PEP-CoV trial) examines the effectiveness on respiratory symptoms and need of hospital admission by regular PEP flute use among non-hospitalised individuals with confirmed SARS-CoV-2 infection and COVID-19 symptoms.Methods and analysisIn this randomised controlled trial, we hypothesise that daily PEP flute usage as add-on to usual care is superior to usual care as regards symptom severity measured by the COPD Assessment Test (CAT) at 30-day follow-up (primary outcome) and hospital admission through register data (secondary outcome). We expect to recruit 400 individuals for the trial. Participants in the intervention group receive a kit of 2 PEP flutes and adequate resistances and access to instruction videos. A telephone hotline offers possible contact to a nurse. The eight-item CAT score measures cough, phlegm, chest tightness, dyspnoea, activities of daily living at home, feeling safe at home despite symptoms, sleep quality and vigour. The CAT score is measured daily in both intervention and control arms by surveys prompted through text messages.Ethics and disseminationThe study was registered prospectively at www.clinicaltrials.gov on 27 August 2020 (NCT04530435). Ethical approval was granted by the local health research ethics committee (Journal number: H-20035929) on 23 July 2020. Enrolment of participants began on 6 October 2020. Results will be published in scientific journals.Trial registration numberNCT04530435; Pre-results.

scholarly journals Effectiveness of custom-made foot orthoses in patients with systemic lupus erythaematosus: protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e042627
Author(s):  
María Reina-Bueno ◽  
María del Carmen Vázquez-Bautista ◽  
Inmaculada C Palomo-Toucedo ◽  
Gabriel Domínguez-Maldonado ◽  
José Manuel Castillo-López ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Foot Orthoses ◽  
Systemic Lupus ◽  
Custom Made ◽  
Randomised Controlled

IntroductionSystemic lupus erythaematosus (SLE) is a chronic autoimmune disease of heterogeneous involvement. The disease may affect feet with a high prevalence of symptoms such as, for example, pain, forefoot and rearfoot deformities, and biomechanics dysfunctions. Custom-made foot orthoses (CMFO) have been previously reported to be effective in patients with other rheumatic diseases. However, as far as the authors know, there exist no studies about their effectiveness in SLE. This study aims at determining the effect of CMFO versus placebo flat cushioning insoles on pain, foot functionality, fatigue and quality of life in patients with SLE.Methods and analysisA randomised controlled trial would compare the effects of (1) CMFO and group B, which received a placebo, flat cushioning insoles, for 3 months. The main outcome measures are foot pain, foot functionality and foot-related disability. The secondary outcome measures are fatigue and quality of life.Ethics and disseminationThe study has been approved by the Portal de Ética de la Investigación Biomédica de Andalucía ethical committee 1494-N-19. The results will be disseminated regardless of the magnitude or direction of effect.Trial registartion numberClinicaltrials.gov identifier NCT04098055.

scholarly journals Cost-effectiveness analysis of an intimate partner violence prevention intervention targeting men, women and couples in rural Ethiopia: evidence from the Unite for a Better Life randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e042365
Author(s):  
Jessica Leight ◽  
Negussie Deyessa ◽  
Vandana Sharma
Keyword(s):  
Intimate Partner Violence ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Partner Violence ◽  
Controlled Trial ◽  
Intimate Partner ◽  
Community Level ◽  
Secondary Outcome ◽  
Randomised Controlled ◽  
The Cost

ObjectivesExperience of intimate partner violence (IPV) is associated with adverse health and psychosocial outcomes for women. However, rigorous economic evaluations of interventions targeting IPV prevention are rare. This paper analyses the cost-effectiveness of Unite for a Better Life (UBL), a gender-transformative intervention designed to prevent IPV and HIV risk behaviours among men, women and couples.DesignWe use an economic evaluation nested within a large-scale cluster randomised controlled trial, analysing financial and economic costs tracked contemporaneously.SettingUBL was implemented in rural southern Ethiopia between 2013 and 2015.ParticipantsThe randomised controlled trial included 6770 households in 64 villages.InterventionsUBL is an intervention delivered within the context of the Ethiopian coffee ceremony, a culturally established forum for community discussion, and designed to assist participants to build skills for healthy, non-violent, equitable relationships.Primary and secondary outcome measuresThis paper reports on the unit cost and cost-effectiveness of the interventions implemented. Cost-effectiveness is measured as the cost per case of past-year physical and/or sexual IPV averted.ResultsThe estimated annualised cost of developing and implementing UBL was 2015 US$296 772, or approximately 2015 US$74 per individual directly participating in the intervention and 2015 US$5 per person annually for each community-level beneficiary (woman of reproductive age in intervention communities). The estimated cost per case of past-year physical and/or sexual IPV averted was 2015 US$2726 for the sample of direct beneficiaries, and 2015 US$194 for the sample of all community-level beneficiaries.ConclusionsUBL is an effective and cost-effective intervention for the prevention of IPV in a low and middle-income country setting. Further research should explore strategies to quantify the positive effects of the intervention across other domains.Trial registration numberNCT02311699 (ClinicalTrials.gov); AEARCTR-0000211 (AEA Registry)

scholarly journals 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 ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e039981
Author(s):  
Maleea Denise Holbert ◽  
Roy M Kimble ◽  
Mark Chatfield ◽  
Bronwyn R Griffin
Keyword(s):  
Randomised Controlled Trial ◽  
Repeated Measures ◽  
Controlled Trial ◽  
Geometric Mean ◽  
First Aid ◽  
Self Report ◽  
Thermal Burn ◽  
Pain Scores ◽  
Registration Number ◽  
Randomised Controlled

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).

A Randomised Controlled Trial of Strategies to Prompt Attendance for a Pap Smear

1995 ◽  
Vol 2 (4) ◽  
pp. 211-218 ◽  
Author(s):  
Jenny Bowman ◽  
Rob Sanson-Fisher ◽  
Catherine Boyle ◽  
Stephanie Pope ◽  
Sally Redman
Keyword(s):  
At Risk ◽  
Randomised Controlled Trial ◽  
Pap Smear ◽  
Controlled Trial ◽  
Self Report ◽  
Health Clinic ◽  
Control Group ◽  
Screening Attendance ◽  
Randomised Controlled

Objective – To assess the comparative efficacy, by randomised controlled trial, of three interventions designed to encourage “at risk” women to have a Pap smear: an educational pamphlet; letters inviting attendance at a women's health clinic; and letters from physicians. Methods – Subjects at risk for cervical cancer who had not been adequately screened were identified by a random community survey and randomly allocated to one of the intervention groups or a control group. Six months after intervention implementation, a follow up survey assessed subsequent screening attendance. Self report was validated by comparison with a national screening data base. Results – A significantly greater proportion of women (36.9%) within the group receiving a physician letter reported screening at follow up than in any other group (P =0.012). The variables most strongly predicting screening attendance were: age, perceived frequency of screening required, use of oral contraceptives, and allocation to receive the physician letter intervention. Conclusions – The relative efficacy of the GP letter in prompting screening attendance shows that this strategy is worthy of further investigation. There remains a need to examine the barriers to screening for older women, and to develop tailored strategies for this population.

scholarly journals Training to enhance psychiatrist communication with patients with psychosis (TEMPO): cluster randomised controlled trial

2016 ◽  
Vol 209 (6) ◽  
pp. 517-524 ◽  
Author(s):  
Rose McCabe ◽  
Paula John ◽  
Jemima Dooley ◽  
Patrick Healey ◽  
Annie Cushing ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Therapeutic Relationship ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Medium Effect ◽  
Secondary Outcome ◽  
Shared Understanding ◽  
Cluster Randomised ◽  
Self Repair ◽  
Randomised Controlled

BackgroundA better therapeutic relationship predicts better outcomes. However, there is no trial-based evidence on how to improve therapeutic relationships in psychosis.AimsTo test the effectiveness of communication training for psychiatrists on improving shared understanding and the therapeutic relationship (trial registration: ISRCTN94846422).MethodIn a cluster randomised controlled trial in the UK, 21 psychiatrists were randomised. Ninety-seven (51% of those approached) out-patients with schizophrenia/schizoaffective disorder were recruited, and 64 (66% of the sample recruited at baseline) were followed up after 5 months. The intervention group received four group and one individualised session. The primary outcome, rated blind, was psychiatrist effort in establishing shared understanding (self-repair). Secondary outcome was the therapeutic relationship.ResultsPsychiatrists receiving the intervention used 44% more self-repair than the control group (adjusted difference in means 6.4, 95% CI 1.46–11.33, P<0.011, a large effect) adjusting for baseline self-repair. Psychiatrists rated the therapeutic relationship more positively (adjusted difference in means 0.20, 95% CI 0.03–0.37, P = 0.022, a medium effect), as did patients (adjusted difference in means 0.21, 95% CI 0.01–0.41, P = 0.043, a medium effect).ConclusionsShared understanding can be successfully targeted in training and improves relationships in treating psychosis.

scholarly journals Shoe cushioning, body mass and running biomechanics as risk factors for running injury: a study protocol for a randomised controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e017379 ◽  
Author(s):  
Laurent Malisoux ◽  
Nicolas Delattre ◽  
Axel Urhausen ◽  
Daniel Theisen
Keyword(s):  
Risk Factors ◽  
Randomised Controlled Trial ◽  
Injury Prevention ◽  
Body Mass ◽  
Injury Risk ◽  
Cox Regression ◽  
Controlled Trial ◽  
Study Groups ◽  
Self Report ◽  
Randomised Controlled

IntroductionRepetitive loading of the musculoskeletal system is suggested to be involved in the underlying mechanism of the majority of running-related injuries (RRIs). Accordingly, heavier runners are assumed to be at a higher risk of RRI. The cushioning system of modern running shoes is expected to protect runners again high impact forces, and therefore, RRI. However, the role of shoe cushioning in injury prevention remains unclear. The main aim of this study is to investigate the influence of shoe cushioning and body mass on RRI risk, while exploring simultaneously the association between running technique and RRI risk.Methods and analysisThis double-blinded randomised controlled trial will involve about 800 healthy leisure-time runners. They will randomly receive one of two running shoe models that will differ in their cushioning properties (ie, stiffness) by ~35%. The participants will perform a running test on an instrumented treadmill at their preferred running speed at baseline. Then they will be followed up prospectively over a 6-month period, during which they will self-report all their sports activities as well as any injury in an internet-based database TIPPS (Training and Injury Prevention Platform for Sports). Cox regression analyses will be used to compare injury risk between the study groups and to investigate the association among training, biomechanical and anatomical risk factors, and injury risk.Ethics and disseminationThe study was approved by the National Ethics Committee for Research (Ref: 201701/02 v1.1). Outcomes will be disseminated through publications in peer-reviewed journals, presentations at international conferences, as well as articles in popular magazines and on specialised websites.Trial registration numberNCT03115437, Pre-results.

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