Community-based Rehabilitation Training after stroke: protocol of a pilot randomised controlled trial (ReTrain).
BMJ Open
; 6(10): e012375, 2016 10 03.
Article
em En
| MEDLINE
| ID: mdl-27697876
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 ANDANALYSIS:
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 11 to ReTrain (25 sessions) or control (exercise advice booklet). Outcome assessment at baseline, 6 and 9â 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.Palavras-chave
Texto completo:
1
Temas:
ECOS
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Avaliacao_economica
Bases de dados:
MEDLINE
Assunto principal:
Avaliação de Programas e Projetos de Saúde
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Pessoas com Deficiência
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Acidente Vascular Cerebral
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Terapia por Exercício
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Reabilitação do Acidente Vascular Cerebral
Tipo de estudo:
Clinical_trials
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Evaluation_studies
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Guideline
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Qualitative_research
Aspecto:
Ethics
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Implementation_research
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Patient_preference
Limite:
Adolescent
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Adult
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Female
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Humans
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Male
Idioma:
En
Revista:
BMJ Open
Ano de publicação:
2016
Tipo de documento:
Article
País de afiliação:
Reino Unido