Introduction The Rehabilitation Training (ReTrain) intervention aims to improve functional mobility, adherence to poststroke exercise guidelines and quality of life for people after stroke. A definitive randomised controlled trial (RCT) is required to assess the clinical and cost-effectiveness of ReTrain, which is based on Action for Rehabilitation from Neurological Injury (ARNI). The purpose of this pilot study is to assess the feasibility of such a definitive trial and inform its design.
Methods and analysis A 2-group, assessor-blinded, randomised controlled external pilot trial with parallel mixed-methods process evaluation and economic evaluation. 48 participants discharged from clinical rehabilitation despite residual physical disability will be individually randomised 1:1 to ReTrain (25 sessions) or control (exercise advice booklet). Outcome assessment at baseline, 6 and 9 months include Rivermead Mobility Index; Timed Up and Go Test; modified Patient-Specific Functional Scale; 7-day accelerometry; Stroke Self-efficacy Questionnaire, exercise diary, Fatigue Assessment Scale, exercise beliefs and self-efficacy questionnaires, SF-12, EQ-5D-5L, Stroke Quality of Life, Carer Burden Index and Service Receipt Inventory. Feasibility, acceptability and process outcomes include recruitment and retention rates; with measurement burden and trial experiences being explored in qualitative interviews (20 participants, 3 intervention providers). Analyses include descriptive statistics, with 95% CI where appropriate; qualitative themes; intervention fidelity from videos and session checklists; rehearsal of health economic analysis.
Ethics and dissemination National Health Service (NHS) National Research Ethics Service approval granted in April 2015; recruitment started in June. Preliminary studies suggested low risk of serious adverse events; however (minor) falls, transitory muscle soreness and high levels of postexercise fatigue are expected. Outputs include pilot data to inform whether to proceed to a definitive RCT and support a funding application; finalised Trainer and Intervention Delivery manuals for multicentre replication of ReTrain; presentations at conferences, public involvement events; internationally recognised peer-reviewed journal publications, open access sources and media releases.
Trial registration number NCT02429180; Pre-results.
- REHABILITATION MEDICINE
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Contributors SGD led the project team and the protocol development; RC wrote the first version of protocol and amendments for ethic submission; LP wrote early drafts of protocol for peer review prior to funding application; AF, MJ, RA, MN, SGD and LP provided stroke and stroke rehabilitation expertise; RST provided statistical and trial methodological expertise; MN provided qualitative expertise; SGD and LP provided process evaluation expertise; AS provided health economic expertise; SS provided patient and public involvement expertise; RC, RST, SGD and AIS provided trial management expertise. All authors commented on the protocol and the manuscript.
Funding The trial is funded by the Stroke Association (TSA-2014-03). Excess treatment costs are being covered by South Devon and Torbay Clinical Commissioning Group and by North East and West Devon Clinical Commissioning Group. This research was supported by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care South West Peninsula at the Royal Devon and Exeter NHS Foundation Trust.
Disclaimer The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.
Competing interests None declared.
Ethics approval NHS National Research Ethics Service, via the Southwest Research Ethics Committee (15/SW/0074).
Provenance and peer review Not commissioned; externally peer reviewed.
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