Objectives To assess acceptability and feasibility of trial processes and the Rehabilitation Training (ReTrain) intervention including an assessment of intervention fidelity.
Design A two-group, assessor-blinded, randomised controlled trial with parallel mixed methods process and economic evaluations.
Setting Community settings across two sites in Devon.
Participants Eligible participants were: 18 years old or over, with a diagnosis of stroke and with self-reported mobility issues, no contraindications to physical activity, discharged from National Health Service or any other formal rehabilitation programme at least 1 month before, willing to be randomised to either control or ReTrain and attend the training venue, possessing cognitive capacity and communication ability sufficient to participate. Participants were individually randomised (1:1) via a computer-generated randomisation sequence minimised for time since stroke and level of functional disability. Only outcome assessors independent of the research team were blinded to group allocation.
Interventions ReTrain comprised (1) an introductory one-to-one session; (2) ten, twice-weekly group classes with up to two trainers and eight clients; (3) a closing one-to-one session, followed by three drop-in sessions over the subsequent 3 months. Participants received a bespoke home-based training programme. All participants received treatment as usual. The control group received an exercise after stroke advice booklet.
Outcome measures Candidate primary outcomes included functional mobility and physical activity.
Results Forty-five participants were randomised (ReTrain=23; Control=22); data were available from 40 participants at 6 months of follow-up (ReTrain=21; Control=19) and 41 at 9 months of follow-up (ReTrain=21; Control=20). We demonstrated ability to recruit and retain participants. Participants were not burdened by the requirements of the study. We were able to calculate sample estimates for candidate primary outcomes and test procedures for process and health economic evaluations.
Conclusions All objectives were fulfilled and indicated that a definitive trial of ReTrain is feasible and acceptable.
Trial registration number NCT02429180; Results.
- stroke medicine
- rehabilitation medicine
- clinical trials
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Contributors SGD: led the team and drafted this article. RC: prepared protocol, ethical submission and amendments, managed the project and contributed to analysis. LP: drafted protocol prior to funding application, conducted interviews and contributed to analysis. AF, MJ, RA, MN, SGD and LP: provided stroke rehabilitation expertise. RST: provided statistical and trial methodological expertise, led analysis. MN: provided qualitative expertise and analysed qualitative data. AIS: led accelerometry work, supported by RMP who provided accelerometry analysis. SGD and LP: provided process evaluation expertise. SGD: led the process evaluation and supervised LH. LH: led video analysis work. AS: provided health economic expertise and led economic work supported by PL. SS: provided patient and public involvement expertise. All authors commented on the manuscript.
Funding The Stroke Association TSA 2014-13.
Competing interests Dean reports grants from The Stroke Association, during the conduct of the study; other from Wiley Blackwell, outside the submitted work; Forster, Poltawski, Spencer, Taylor, James, Allison, Stevens, Pulsford and Norris report grants from the Stroke Association; Calitri, Landa, Hollands, Shepherd were employed by the Stroke Association grant.
Patient consent Obtained.
Ethics approval NRES Committee South West—Cornwall & Plymouth (REC ref: 15/SW/04).
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Participants did not consent for datasets to be stored or accessed outside of the research team. Therefore, no datasets have been made publicly available.
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