Exercise After Intensive Care Unit: a Randomised Controlled Trial

Critical Illness Clinical Trial

— REVIVE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01463579
• Other study ID #: 11/0291
• Status: Completed
• Phase: Phase 2
• First received: September 8, 2011
• Last updated: December 11, 2015
• Start date: December 2011
• Est. completion date: April 2015

Study information

• Verified date: December 2015
• Source: University of Ulster
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Intensive Care

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
United Kingdom	Northern Health and Social Care Trust	Antrim	Co. Antrim
United Kingdom	Belfast Health and Social Care Trust	Belfast	Co. Antrim
United Kingdom	Southern Health and Social Care Trust	Craigavon	Co. Armagh
United Kingdom	Western Health and Social Care Trust	Derry	Co. Londonderry
United Kingdom	South Eastern Health and Social Care Trust	Dundonald, Co Down

Sponsors (2)

Lead Sponsor	Collaborator
University of Ulster	Belfast Health and Social Care Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Functioning subscale of the SF-36	The primary outcome measure will be physical function as measured by the physical functioning (PF) subscale of the SF-36v2 following the exercise programme. This is an important outcome that is meaningful to patients. This has been shown to be an acceptable, reliable and valid tool following critical illness.	6 weeks	No
Secondary	Physical Functioning Subscale of the SF-36		6 months	No
Secondary	Rivermead Mobility Index	Physical Function will also be measured using the Rivermead Mobility Index.	6 weeks, 6 months	No
Secondary	Hand Dynamometry	Patients have indicated to us that hand function is particularly slow to return after critical illness and that this is important to them. Strength and dexterity will specifically be measured by dynamometry and the Nine Hole Peg Test.	6 weeks, 6 months	No
Secondary	The Nine Hole Peg Test	Patients have indicated to us that hand function is particularly slow to return after critical illness and that this is important to them. Strength and dexterity will specifically be measured by dynamometry and the Nine Hole Peg Test.	6 weeks, 6 months	No
Secondary	Incremental Shuttle Walk Test	Exercise capacity will be measured with the Incremental Shuttle Walk Test (ISWT). This is a valid and standardised test of exercise capacity which is responsive to exercise based interventions in other populations. Furthermore the ISWT was used in our pilot study and demonstrated the feasibility and responsiveness of this measure.	6 weeks, 6 months	No
Secondary	Functional Limitations Profile	Health related quality of life (HRQoL) will also be measured using Functional Limitations Profile (FLP) questionnaire. The FLP questionnaire is a well validated and widely used generic instrument to measure health status in a variety of conditions including critical illness. It provides an estimate of sickness related dysfunction and has both physical and psychosocial dimensions. It was used in our pilot study.	6 weeks, 6 months	No
Secondary	other subscales of the SF-36	Health Related Quality of Life (HRQoL) is also assessed using other subscales of the SF-36v2, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Scores are provided for each of these health domains, and two summary measures of physical and mental health: the Physical Component Summary (PCS) and Mental Component Summary (MCS).	6 weeks, 6 months	No
Secondary	Hospital Anxiety and Depression Scale	Anxiety and depression function will be measured using the Hospital Anxiety and Depression Scale (HADS). The HADS contains 14 statements and scores from 0-21. Scores of 8-10 indicate the possibility of anxiety or depression, and 11 and above indicate that these are likely to be present. It has been validated in the critical care population.	6 weeks, 6 months	No
Secondary	'Readiness to change' questionnaire	Patient's readiness to exercise and self efficacy to exercise are important aspects of feasibility when commencing an exercise programme. Readiness to commence exercise following critical illness will be obtained by assessing components relating to the transtheoretical model (stages, processes, decisional balance, self-efficacy). There is evidence of reliability and validity of the questionnaires designed to measure these constructs.	6 weeks, 6 months	No
Secondary	Chronic Disease Self Efficacy Scale (Exercise component)	The exercise component of the Chronic Disease Self Efficacy Scale will be used to measure self efficacy relating to exercise.	6 weeks, 6 months	No
Secondary	The EuroQol-5D	The EuroQol-5D is a useful measure of health related quality of life in a mixed critical care population.	6 weeks, 6 months	No
Secondary	Medical Research Council Dyspnoea Scale	Breathlessness will be measured by the Medical Research Council dyspnoea scale. Breathlessness is a common problem encountered by these patients and an important patient focused outcome.	6 weeks, 6 months	No
Secondary	'Healthcare Utilisation' Questionnaire		6 months	No
Secondary	Semi-structured Interview	Patient's perceptions of the exercise programme will be explored.	6 months	No