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Community-based Rehabilitation Training after stroke: protocol of a pilot randomised controlled trial (ReTrain)
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 R...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BMJ Publishing Group
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5073546/ https://www.ncbi.nlm.nih.gov/pubmed/27697876 http://dx.doi.org/10.1136/bmjopen-2016-012375 |
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author | Dean, Sarah G Poltawski, Leon Forster, Anne Taylor, Rod S Spencer, Anne James, Martin Allison, Rhoda Stevens, Shirley Norris, Meriel Shepherd, Anthony I Calitri, Raff |
author_facet | Dean, Sarah G Poltawski, Leon Forster, Anne Taylor, Rod S Spencer, Anne James, Martin Allison, Rhoda Stevens, Shirley Norris, Meriel Shepherd, Anthony I Calitri, Raff |
author_sort | Dean, Sarah G |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-5073546 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-50735462016-11-07 Community-based Rehabilitation Training after stroke: protocol of a pilot randomised controlled trial (ReTrain) Dean, Sarah G Poltawski, Leon Forster, Anne Taylor, Rod S Spencer, Anne James, Martin Allison, Rhoda Stevens, Shirley Norris, Meriel Shepherd, Anthony I Calitri, Raff BMJ Open Rehabilitation Medicine 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. BMJ Publishing Group 2016-10-03 /pmc/articles/PMC5073546/ /pubmed/27697876 http://dx.doi.org/10.1136/bmjopen-2016-012375 Text en Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ 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/ |
spellingShingle | Rehabilitation Medicine Dean, Sarah G Poltawski, Leon Forster, Anne Taylor, Rod S Spencer, Anne James, Martin Allison, Rhoda Stevens, Shirley Norris, Meriel Shepherd, Anthony I Calitri, Raff Community-based Rehabilitation Training after stroke: protocol of a pilot randomised controlled trial (ReTrain) |
title | Community-based Rehabilitation Training after stroke: protocol of a pilot randomised controlled trial (ReTrain) |
title_full | Community-based Rehabilitation Training after stroke: protocol of a pilot randomised controlled trial (ReTrain) |
title_fullStr | Community-based Rehabilitation Training after stroke: protocol of a pilot randomised controlled trial (ReTrain) |
title_full_unstemmed | Community-based Rehabilitation Training after stroke: protocol of a pilot randomised controlled trial (ReTrain) |
title_short | Community-based Rehabilitation Training after stroke: protocol of a pilot randomised controlled trial (ReTrain) |
title_sort | community-based rehabilitation training after stroke: protocol of a pilot randomised controlled trial (retrain) |
topic | Rehabilitation Medicine |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5073546/ https://www.ncbi.nlm.nih.gov/pubmed/27697876 http://dx.doi.org/10.1136/bmjopen-2016-012375 |
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