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Effectiveness of a programme of exercise on physical function in survivors of critical illness following discharge from the ICU: study protocol for a randomised controlled trial (REVIVE)

BACKGROUND: Following discharge home from the ICU, patients often suffer from reduced physical function, exercise capacity, health-related quality of life and social functioning. There is usually no support to address these longer term problems, and there has been limited research carried out into i...

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Autores principales: O'Neill, Brenda, McDowell, Kathryn, Bradley, Judy, Blackwood, Bronagh, Mullan, Brian, Lavery, Gavin, Agus, Ashley, Murphy, Sally, Gardner, Evie, McAuley, Daniel F
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4005901/
https://www.ncbi.nlm.nih.gov/pubmed/24767671
http://dx.doi.org/10.1186/1745-6215-15-146
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author O'Neill, Brenda
McDowell, Kathryn
Bradley, Judy
Blackwood, Bronagh
Mullan, Brian
Lavery, Gavin
Agus, Ashley
Murphy, Sally
Gardner, Evie
McAuley, Daniel F
author_facet O'Neill, Brenda
McDowell, Kathryn
Bradley, Judy
Blackwood, Bronagh
Mullan, Brian
Lavery, Gavin
Agus, Ashley
Murphy, Sally
Gardner, Evie
McAuley, Daniel F
author_sort O'Neill, Brenda
collection PubMed
description BACKGROUND: Following discharge home from the ICU, patients often suffer from reduced physical function, exercise capacity, health-related quality of life and social functioning. There is usually no support to address these longer term problems, and there has been limited research carried out into interventions which could improve patient outcomes. The aim of this study is to investigate the effectiveness and cost-effectiveness of a 6-week programme of exercise on physical function in patients discharged from hospital following critical illness compared to standard care. METHODS/DESIGN: The study design is a multicentre prospective phase II, allocation-concealed, assessor-blinded, randomised controlled clinical trial. Participants randomised to the intervention group will complete three exercise sessions per week (two sessions of supervised exercise and one unsupervised session) for 6 weeks. Supervised sessions will take place in a hospital gymnasium or, if this is not possible, in the participants home and the unsupervised session will take place at home. Blinded outcome assessment will be conducted at baseline after hospital discharge, following the exercise intervention, and at 6 months following baseline assessment (or equivalent time points for the standard care group). The primary outcome measure is physical function as measured by the physical functioning subscale of the Short-Form-36 health survey following the exercise programme. Secondary outcomes are health-related quality of life, exercise capacity, anxiety and depression, self efficacy to exercise and healthcare resource use. In addition, semi-structured interviews will be conducted to explore participants’ perceptions of the exercise programme, and the feasibility (safety, practicality and acceptability) of providing the exercise programme will be assessed. A within-trial cost-utility analysis to assess the cost-effectiveness of the intervention compared to standard care will also be conducted. DISCUSSION: If the exercise programme is found to be effective, this study will improve outcomes that are meaningful to patients and their families. It will inform the design of a future multicentre phase III clinical trial of exercise following recovery from critical illness. It will provide useful information which will help the development of services for patients after critical illness. TRIAL REGISTRATION: ClinicalTrials.gov NCT01463579
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spelling pubmed-40059012014-05-02 Effectiveness of a programme of exercise on physical function in survivors of critical illness following discharge from the ICU: study protocol for a randomised controlled trial (REVIVE) O'Neill, Brenda McDowell, Kathryn Bradley, Judy Blackwood, Bronagh Mullan, Brian Lavery, Gavin Agus, Ashley Murphy, Sally Gardner, Evie McAuley, Daniel F Trials Study Protocol BACKGROUND: Following discharge home from the ICU, patients often suffer from reduced physical function, exercise capacity, health-related quality of life and social functioning. There is usually no support to address these longer term problems, and there has been limited research carried out into interventions which could improve patient outcomes. The aim of this study is to investigate the effectiveness and cost-effectiveness of a 6-week programme of exercise on physical function in patients discharged from hospital following critical illness compared to standard care. METHODS/DESIGN: The study design is a multicentre prospective phase II, allocation-concealed, assessor-blinded, randomised controlled clinical trial. Participants randomised to the intervention group will complete three exercise sessions per week (two sessions of supervised exercise and one unsupervised session) for 6 weeks. Supervised sessions will take place in a hospital gymnasium or, if this is not possible, in the participants home and the unsupervised session will take place at home. Blinded outcome assessment will be conducted at baseline after hospital discharge, following the exercise intervention, and at 6 months following baseline assessment (or equivalent time points for the standard care group). The primary outcome measure is physical function as measured by the physical functioning subscale of the Short-Form-36 health survey following the exercise programme. Secondary outcomes are health-related quality of life, exercise capacity, anxiety and depression, self efficacy to exercise and healthcare resource use. In addition, semi-structured interviews will be conducted to explore participants’ perceptions of the exercise programme, and the feasibility (safety, practicality and acceptability) of providing the exercise programme will be assessed. A within-trial cost-utility analysis to assess the cost-effectiveness of the intervention compared to standard care will also be conducted. DISCUSSION: If the exercise programme is found to be effective, this study will improve outcomes that are meaningful to patients and their families. It will inform the design of a future multicentre phase III clinical trial of exercise following recovery from critical illness. It will provide useful information which will help the development of services for patients after critical illness. TRIAL REGISTRATION: ClinicalTrials.gov NCT01463579 BioMed Central 2014-04-27 /pmc/articles/PMC4005901/ /pubmed/24767671 http://dx.doi.org/10.1186/1745-6215-15-146 Text en Copyright © 2014 O'Neill et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited.
spellingShingle Study Protocol
O'Neill, Brenda
McDowell, Kathryn
Bradley, Judy
Blackwood, Bronagh
Mullan, Brian
Lavery, Gavin
Agus, Ashley
Murphy, Sally
Gardner, Evie
McAuley, Daniel F
Effectiveness of a programme of exercise on physical function in survivors of critical illness following discharge from the ICU: study protocol for a randomised controlled trial (REVIVE)
title Effectiveness of a programme of exercise on physical function in survivors of critical illness following discharge from the ICU: study protocol for a randomised controlled trial (REVIVE)
title_full Effectiveness of a programme of exercise on physical function in survivors of critical illness following discharge from the ICU: study protocol for a randomised controlled trial (REVIVE)
title_fullStr Effectiveness of a programme of exercise on physical function in survivors of critical illness following discharge from the ICU: study protocol for a randomised controlled trial (REVIVE)
title_full_unstemmed Effectiveness of a programme of exercise on physical function in survivors of critical illness following discharge from the ICU: study protocol for a randomised controlled trial (REVIVE)
title_short Effectiveness of a programme of exercise on physical function in survivors of critical illness following discharge from the ICU: study protocol for a randomised controlled trial (REVIVE)
title_sort effectiveness of a programme of exercise on physical function in survivors of critical illness following discharge from the icu: study protocol for a randomised controlled trial (revive)
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4005901/
https://www.ncbi.nlm.nih.gov/pubmed/24767671
http://dx.doi.org/10.1186/1745-6215-15-146
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