feasibility randomised controlled trial
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2021 ◽  
pp. 026921552110649
Author(s):  
Julie Louie ◽  
Katherine Baquie ◽  
Justin Offerman ◽  
Catherine L. Granger ◽  
Fary Khan ◽  
...  

Objective To investigate the feasibility and preliminary efficacy of a group self-management exercise and education program in people with multiple sclerosis. Design Feasibility randomised controlled trial. Setting Outpatient rehabilitation facility. Subjects Twenty-three adults (age 48.6 (11.7) years) recruited from a Multiple Sclerosis Clinic register. Interventions The intervention group undertook a 12-week group program incorporating behaviour change education, exercise and community integration. This was compared with a waitlist control group. Main measures Feasibility was measured by recruitment, adherence and safety. Efficacy outcomes included measures of physical function (6-metre and 6-min walk, Functional Reach) and self-report questionnaires (fatigue, quality of life, exercise benefits and barriers) at baseline, 6, 12 and 24 weeks. Results Of 74 individuals identified through the register, 48 (65%) were contacted and deemed eligible, and 23 (48%) agreed to participate. There was high adherence for attendance at education (57 of 72, 79%) and exercise (135 of 174, 78%) sessions. No adverse safety events occurred within the intervention sessions. Missed attendances at assessment sessions was high (5 to 8 participants missed at each time point) predominately due to health issues. The intervention group demonstrated positive changes in walking endurance, Functional Reach and fatigue, whereas the control had some reductions in walking speed and more perceived exercise barriers. Conclusions The MANAGE program appears feasible and safe for people with mild-to-moderate multiple sclerosis, with high adherence to exercise and education sessions. Future trials should consider strategies such as flexible scheduling or alternative methods of data collection to improve follow-up assessment attendance.


BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e048932
Author(s):  
Rachel Stocker ◽  
James Shaw ◽  
Guy S Taylor ◽  
Miles D Witham ◽  
Daniel J West

IntroductionThere are 3.9 million people in the UK with diabetes. Sarcopenia, increased frailty and loss of independence are often unappreciated complications of diabetes. Resistance exercise shows promise in reducing these complications in older adult diabetes patients. The aim of this feasibility randomised controlled trial is to (1) characterise the physical function, cardiovascular health and the health and well-being of older adults with mild frailty with/without diabetes treated with insulin, (2) to understand the feasibility and acceptability of a 4-week resistance exercise training programme in improving these parameters for those with diabetes and (3) to test the feasibility of recruiting and randomising the diabetic participant group to a trial of resistance training.Methods and analysisThirty adults aged ≥60 years with insulin-treated diabetes mellitus (type 1 or 2), and 30 without, all with mild frailty (3–4 on the Rockwood Frailty Scale) will be recruited. All will complete blood, cardiovascular and physical function testing. Only the diabetic group will then proceed into the trial itself. They will be randomised 1:1 to a 4-week semisupervised resistance training programme, designed to increase muscle mass and strength, or to usual care, defined as their regular physical activity, for 4 weeks. This group will then repeat testing. Primary outcomes include recruitment rate, attrition rate, intervention fidelity and acceptability, and adherence to the training programme. A subset of participants will be interviewed before and after the training programme to understand experiences of resistance training, impact on health and living with diabetes (where relevant) as they have aged. Analyses will include descriptive statistics and qualitative thematic analysis.Ethics and disseminationThe North East-Newcastle and North Tyneside 2 Research Ethics Committee (20/NE/0178) approved the study. Outputs will include feasibility data to support funding applications for a future definitive trial, conference and patient and public involvement presentations, and peer-reviewed publications.Trial registration numberISRCTN13193281.


2021 ◽  
Author(s):  
Marcus Bateman ◽  
Benjamin Saunders ◽  
Chris Littlewood ◽  
Daniel Davis ◽  
Jacqueline Beckhelling ◽  
...  

Abstract BackgroundPhysiotherapy is recommended for people with Tennis Elbow, but whilst a wide array of treatments is available, the optimal approach remains uncertain. We have therefore recently developed an optimised physiotherapy treatment package for Tennis Elbow based on a synthesis of the evidence, patient input, and clinical consensus. It consists of detailed advice and education, a structured progressive exercise programme and provision of a counter-force elbow brace. Here we report the protocol for our multi-centre pilot and feasibility randomised controlled trial (RCT) designed to a) examine the feasibility of our optimised physiotherapy treatment package, and b) to pilot trial processes for a future fully-powered RCT to test clinical and cost-effectiveness compared with usual physiotherapy treatment.MethodsA multi-centre pilot and feasibility RCT will be conducted across three sites in England, recruiting up to 50 patients (or for a maximum of 12 months). Participants with Tennis Elbow, identified from physiotherapy clinic waiting lists and general practice surgeries, will be randomly allocated to receive the optimised physiotherapy treatment package or usual physiotherapy care. Analysis will focus on feasibility measures including; consent rate, intervention fidelity, follow-up rate, and outcome completion rate. A nested qualitative study will explore the acceptability of the study processes and patient and physiotherapist experiences of the new optimised intervention.DiscussionThis study will determine the feasibility of a new optimised physiotherapy treatment package for people with Tennis Elbow and pilot the processes for a future fully-powered RCT. In the longer term, this treatment package may improve pain and quality of life outcomes for people with Tennis Elbow and help to guide a more clinically and economically efficient treatment pathway design.Trial RegistrationRegistered with the ISRCTN database 19/7/2021. https://www.isrctn.com/ISRCTN64444585


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