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Open Access Study protocol

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)

Brenda O'Neill1*, Kathryn McDowell1, Judy Bradley12, Bronagh Blackwood3, Brian Mullan4, Gavin Lavery4, Ashley Agus5, Sally Murphy4, Evie Gardner5 and Daniel F McAuley345

Author Affiliations

1 Centre for Health and Rehabilitation Technologies (CHaRT), Institute of Nursing and Health Research, School of Health Sciences, University of Ulster, Newtownabbey BT37 0QB, UK

2 Department of Respiratory Medicine, BHSCT, Belfast City Hospital site, Belfast BT9 7ER, UK

3 Centre for Infection and Immunity, School of Medicine, Dentistry and Biomedical Sciences, Queen’s University of Belfast, Belfast BT9 7AE, UK

4 Regional Intensive Care Unit, Royal Hospitals at BHSCT, Grosvenor Road, Belfast BT12 6BA, UK

5 Northern Ireland Clinical Trials Unit (NICTU), The Royal Hospitals, Grosvenor Road, 1st Floor Elliot Dynes Building, Belfast BT12 6BA, UK

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Trials 2014, 15:146  doi:10.1186/1745-6215-15-146

Published: 27 April 2014

Abstract

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

Keywords:
Critical illness; Critical care; Intensive care unit; Rehabilitation; Exercise programme; Physical function; Health-related quality of life