Clinical trial NCT01463579: Exercise After Intensive Care Unit: a Randomised Controlled Trial
Official title: Effectiveness of a Programme of Exercise on Physical Function in Survivors of Critical Illness Following Discharge From the Intensive Care Unit (ICU): a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Critical Illness
Intensive Care
Keywords: Intensive Care Unit
Critical Illness
Rehabilitation
Exercise Programme
Lead sponsor: University of Ulster
Sponsor class: OTHER
Collaborators: name: Belfast Health and Social Care Trust
First posted: 2011-11-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Physical Functioning subscale of the SF-36
timeFrame: 6 weeks
Secondary outcomes:
measure: Physical Functioning Subscale of the SF-36
timeFrame: 6 months
measure: Rivermead Mobility Index
timeFrame: 6 weeks, 6 months
measure: Hand Dynamometry
timeFrame: 6 weeks, 6 months
measure: The Nine Hole Peg Test
timeFrame: 6 weeks, 6 months
measure: Incremental Shuttle Walk Test
timeFrame: 6 weeks, 6 months
measure: Functional Limitations Profile
timeFrame: 6 weeks, 6 months
measure: other subscales of the SF-36
timeFrame: 6 weeks, 6 months
measure: Hospital Anxiety and Depression Scale
timeFrame: 6 weeks, 6 months
measure: 'Readiness to change' questionnaire
timeFrame: 6 weeks, 6 months
measure: Chronic Disease Self Efficacy Scale (Exercise component)
timeFrame: 6 weeks, 6 months
measure: The EuroQol-5D
timeFrame: 6 weeks, 6 months
measure: Medical Research Council Dyspnoea Scale
timeFrame: 6 weeks, 6 months
measure: 'Healthcare Utilisation' Questionnaire
timeFrame: 6 months
measure: Semi-structured Interview
timeFrame: 6 months
Other outcomes:
Locations:
city: Antrim
country: United Kingdom
facility: Northern Health and Social Care Trust
state: Co. Antrim
city: Belfast
country: United Kingdom
facility: Belfast Health and Social Care Trust
state: Co. Antrim
city: Craigavon
country: United Kingdom
facility: Southern Health and Social Care Trust
state: Co. Armagh
city: Derry
country: United Kingdom
facility: Western Health and Social Care Trust
state: Co. Londonderry
city: Dundonald, Co Down
country: United Kingdom
facility: South Eastern Health and Social Care Trust
Study officials:
affiliation: University of Ulster
name: Dr Brenda O'Neill, PhD, BSc Hons Physiotherapy
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.