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Exercise After Intensive Care Unit: a Randomised Controlled Trial

NCT ID: NCT01463579

Last Updated: 2015-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2015-04-30

Brief Summary

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The purpose of this study is to test if a 6-week programme of exercise improves physical function and health related quality of life in patients following intensive care who are discharged from hospital. In this study the investigators will compare the physical function and health related quality of life of patients who attend the programme with patients who do not. The 6 week exercise programme will be run by physiotherapy staff, and will mostly take place in a hospital gym. The investigators will measure patients' physical function, exercise capacity, level of breathlessness and their quality of life before and after the 6-week programme, and 6 months later. The investigators will also interview patients to ask their views about the acceptability, enjoyment and satisfaction with the exercise programme. If this study shows that the physical function and health related quality of life are improved in those who took part in the exercise programme, then it will provide useful information which will help the development of services for patients after critical illness. The results will also provide information which will help us design future clinical trials for this patient population.

Detailed Description

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Most critically ill adult patients require ventilatory support during their intensive care unit stay. Following discharge home patients often still suffer from reduced physical function, exercise capacity, health related quality of life and social functioning for at least 2 years. There is usually no support to address these longer term problems specific to critical illness for patients after hospital discharge. Little research has been carried out into interventions which could improve physical function and quality of life, or enhance speed of recovery in these patients. While there is evidence to support the rehabilitation of critically ill patients within intensive care units, there is a paucity of literature to support rehabilitation following discharge from intensive care and hospital. Therefore, there is a clear and urgent need to investigate interventions which could improve the recovery of patients discharged home after intensive care. This is emerging as a prominent therapeutic objective for the future for this population.

This study will investigate whether a programme of exercise following discharge from hospital will improve outcome in patients following critical illness compared to standard care.

Conditions

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Critical Illness Intensive Care

Keywords

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Intensive Care Unit Critical Illness Rehabilitation Exercise Programme

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Exercise programme

Group Type EXPERIMENTAL

Exercise Programme

Intervention Type OTHER

Patients will complete three exercise sessions per week (2 supervised and 1 unsupervised) for 6 weeks. They will receive a written exercise manual which facilitates completion of their exercise programme. The exercise programme will consist of a warm-up, an exercise circuit, a period of aerobic exercise, and a cool down. The programme will be tailored to each patient's ability and needs.

At the end of the 6 weeks patients will receive a short consultation to set goals relating to continuing exercise at home.

Standard Care

Group Type OTHER

Standard Care

Intervention Type OTHER

Following ICU admission patients are discharged to hospital wards to the care of a consultant, and the patients are no longer under the care of the ICU team. They are provided with appropriate medical and nursing care, and with referral to other disciplines as necessary. One mobile and able to return home to a carer or another facility they are discharged from hospital. There is usually no support to address potential problems specific to critical illness for patients after ICU discharge.

Interventions

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Exercise Programme

Patients will complete three exercise sessions per week (2 supervised and 1 unsupervised) for 6 weeks. They will receive a written exercise manual which facilitates completion of their exercise programme. The exercise programme will consist of a warm-up, an exercise circuit, a period of aerobic exercise, and a cool down. The programme will be tailored to each patient's ability and needs.

At the end of the 6 weeks patients will receive a short consultation to set goals relating to continuing exercise at home.

Intervention Type OTHER

Standard Care

Following ICU admission patients are discharged to hospital wards to the care of a consultant, and the patients are no longer under the care of the ICU team. They are provided with appropriate medical and nursing care, and with referral to other disciplines as necessary. One mobile and able to return home to a carer or another facility they are discharged from hospital. There is usually no support to address potential problems specific to critical illness for patients after ICU discharge.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* age ≥ 18 years
* ICU admission requiring mechanical ventilation \> 96 hours
* planned discharge to home (self-care/carer)
* willing and able to participate in exercise
* deemed medically fit to take part in the intervention

Exclusion Criteria

* declined consent or unable to give consent
* inability to participate due to e.g. any neurological, spinal or skeletal dysfunction affecting ability to exercise
* cognitive impairment affecting ability to understand the intervention or complete questionnaires
* participation in another rehabilitation programme due to ongoing chronic disease
* other medical contraindication to participation in an exercise programme
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Belfast Health and Social Care Trust

OTHER

Sponsor Role collaborator

University of Ulster

OTHER

Sponsor Role lead

Responsible Party

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Brenda O'Neill

Dr Brenda O'Neill

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dr Brenda O'Neill, PhD, BSc Hons Physiotherapy

Role: PRINCIPAL_INVESTIGATOR

University of Ulster

Locations

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Northern Health and Social Care Trust

Antrim, Co. Antrim, United Kingdom

Site Status

Belfast Health and Social Care Trust

Belfast, Co. Antrim, United Kingdom

Site Status

Southern Health and Social Care Trust

Craigavon, Co. Armagh, United Kingdom

Site Status

Western Health and Social Care Trust

Londonderry, Co. Londonderry, United Kingdom

Site Status

South Eastern Health and Social Care Trust

Dundonald, Co Down, , United Kingdom

Site Status

Countries

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United Kingdom

References

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O'Neill B, McDowell K, Bradley J, Blackwood B, Mullan B, Lavery G, Agus A, Murphy S, Gardner E, McAuley DF. 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). Trials. 2014 Apr 27;15:146. doi: 10.1186/1745-6215-15-146.

Reference Type BACKGROUND
PMID: 24767671 (View on PubMed)

McDowell K, O'Neill B, Blackwood B, Clarke C, Gardner E, Johnston P, Kelly M, McCaffrey J, Mullan B, Murphy S, Trinder TJ, Lavery G, McAuley DF, Bradley JM. Effectiveness of an exercise programme on physical function in patients discharged from hospital following critical illness: a randomised controlled trial (the REVIVE trial). Thorax. 2017 Jul;72(7):594-595. doi: 10.1136/thoraxjnl-2016-208723. Epub 2016 Nov 15.

Reference Type DERIVED
PMID: 27852953 (View on PubMed)

Other Identifiers

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11/0291

Identifier Type: -

Identifier Source: org_study_id