Community-based Rehabilitation Training after stroke: protocol of a pilot randomised controlled trial (ReTrain)
BMJ Publishing Group
This is the author accepted manuscript. The final version is available from BMJ Publishing Group via the DOI in this record.
Introduction: The ReTrain intervention aims to improve functional mobility, adherence to post-stroke exercise guidelines and quality of life for people after stroke. A definitive randomised controlled trial is required to assess the clinical and cost effectiveness of ReTrain, which is based on ARNI (Action for Rehabilitation from Neurological Injury). The purpose of this pilot study is to assess the feasibility of such a definitive trial and inform its design. Methods and analysis: A two-group, assessor-blinded, randomised controlled external pilot trial with parallel mixed methods process evaluation and economic evaluation. Forty-eight 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, SF12, 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, three 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: NHS National Research Ethics Service approval granted in April 2015; recruitment commenced June. Preliminary studies suggested low risk of serious adverse events however (minor) falls, transitory muscle soreness and high levels of post exercise-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. Registration: ClinicalTrials.gov: trial number NCT02429180. Strengths and Limitations • This pilot RCT study meets the MRC guidance on the development and evaluation of complex interventions and includes comprehensive Patient and Public Involvement. • This preliminary evaluation of a late stage rehabilitation programme addresses the gap in the evidence related to what facilitates stroke recovery in the longer term. • This is small scale study is designed to estimate effect sizes but has insufficient statistical power to detect differences in outcomes between groups. • The follow up period is relatively short compared to what would be planned for a fully funded definitive trial.
We would like to thank the Stroke Association for funding this pilot RCT. We are very grateful for PenCLAHRC for their support of the study and to the Peninsula Patient Involvement Group for helping guide the trial design. Dr Dean discloses textbook royalties from Wiley Blackwell for work outside the submitted work; all authors report the Stroke Association funding for the work under consideration but no other conflicts of interest. 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. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.
Vol. 6, Iss. 10, e012375