Article Text

PDF

Community-based Rehabilitation Training after stroke: protocol of a pilot randomised controlled trial (ReTrain)
  1. Sarah G Dean1,
  2. Leon Poltawski1,
  3. Anne Forster2,
  4. Rod S Taylor1,
  5. Anne Spencer1,
  6. Martin James1,3,
  7. Rhoda Allison4,
  8. Shirley Stevens1,
  9. Meriel Norris5,
  10. Anthony I Shepherd6,
  11. Raff Calitri1
  1. 1University of Exeter Medical School & PenCLAHRC, Exeter, UK
  2. 2ResearchAcademic Unit of Elderly Care and Rehabilitation, University of Leeds, Bradford, UK
  3. 3Royal Devon & Exeter Hospital, Exeter, UK
  4. 4Torbay and South Devon NHS Foundation Trust, Torquay, UK
  5. 5Department of Clinical Sciences, Brunel University London, Middlesex, UK
  6. 6Department of Sport and Exercise Science, University of Portsmouth, Portsmouth, UK
  1. Correspondence to Professor Sarah Dean; s.dean{at}exeter.ac.uk

Abstract

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

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

Statistics from Altmetric.com

Footnotes

  • 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.

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.