title: Community-based Rehabilitation Training after stroke: protocol of a pilot randomised controlled trial (ReTrain).
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  NCT02429180; Pre-results.
authors.affiliation: University of Exeter Medical School & PenCLAHRC, Exeter, UK.
authors.forename: Sarah G
authors.initials: SG
authors.lastname: Dean
authors.affiliation: University of Exeter Medical School & PenCLAHRC, Exeter, UK.
authors.forename: Leon
authors.initials: L
authors.lastname: Poltawski
authors.affiliation: ResearchAcademic Unit of Elderly Care and Rehabilitation, University of Leeds, Bradford, UK.
authors.forename: Anne
authors.initials: A
authors.lastname: Forster
authors.affiliation: University of Exeter Medical School & PenCLAHRC, Exeter, UK.
authors.forename: Rod S
authors.initials: RS
authors.lastname: Taylor
authors.affiliation: University of Exeter Medical School & PenCLAHRC, Exeter, UK.
authors.forename: Anne
authors.initials: A
authors.lastname: Spencer
authors.affiliation: University of Exeter Medical School & PenCLAHRC, Exeter, UK Royal Devon & Exeter Hospital, Exeter, UK.
authors.forename: Martin
authors.initials: M
authors.lastname: James
authors.affiliation: Torbay and South Devon NHS Foundation Trust, Torquay, UK.
authors.forename: Rhoda
authors.initials: R
authors.lastname: Allison
authors.affiliation: University of Exeter Medical School & PenCLAHRC, Exeter, UK.
authors.forename: Shirley
authors.initials: S
authors.lastname: Stevens
authors.affiliation: Department of Clinical Sciences, Brunel University London, Middlesex, UK.
authors.forename: Meriel
authors.initials: M
authors.lastname: Norris
authors.affiliation: Department of Sport and Exercise Science, University of Portsmouth, Portsmouth, UK.
authors.forename: Anthony I
authors.initials: AI
authors.lastname: Shepherd
authors.affiliation: University of Exeter Medical School & PenCLAHRC, Exeter, UK.
authors.forename: Raff
authors.initials: R
authors.lastname: Calitri
mesh_terms: D000203:Activities of Daily Living; D000293:Adolescent; D000328:Adult; D002985:Clinical Protocols; D006233:Persons with Disabilities; D005081:Exercise Therapy; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D017063:Outcome Assessment, Health Care; D010865:Pilot Projects; D015397:Program Evaluation; D011788:Quality of Life; D020521:Stroke; D000071939:Stroke Rehabilitation
keywords: REHABILITATION MEDICINE