Exercise After Intensive Care Unit: a Randomised Controlled Trial

NCT01463579 | Completed Phase 2 DMC

• 1 other identifier: 11/0291
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

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.

Conditions

Critical Illness; Intensive Care

Keywords

Intensive Care Unit; Critical Illness; Rehabilitation; Exercise Programme

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (14)

• Physical Functioning Subscale of the SF-36

  6 months

• Rivermead Mobility Index

  6 weeks, 6 months

• Hand Dynamometry

  6 weeks, 6 months

• The Nine Hole Peg Test

  6 weeks, 6 months

• Incremental Shuttle Walk Test

  6 weeks, 6 months

Study Arms (2)

Exercise programme

EXPERIMENTAL

Other: Exercise Programme

Standard Care

OTHER

Other: Standard Care

Interventions

Exercise Programme 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.

Exercise programme

Standard Care 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.

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ulster: lead
• Belfast Health and Social Care Trust: collaborator

Study Sites (5)

Northern Health and Social Care Trust

Antrim, Co. Antrim, BT41 2RL, United Kingdom

Location

Belfast Health and Social Care Trust

Belfast, Co. Antrim, BT12 6BA, United Kingdom

Location

Southern Health and Social Care Trust

Craigavon, Co. Armagh, BT63 5QQ, United Kingdom

Location

Western Health and Social Care Trust

Londonderry, Co. Londonderry, BT47 6SB, United Kingdom

Location

South Eastern Health and Social Care Trust

Dundonald, Co Down, BT16 1RH, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 24767671 BACKGROUND

• 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.

  PMID: 27852953 DERIVED

MeSH Terms

Conditions

Critical Illness

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Dr Brenda O'Neill, PhD, BSc Hons Physiotherapy

  University of Ulster

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Brenda O'Neill

Study Record Dates

• First Submitted: September 8, 2011
• First Posted: November 2, 2011
• Study Start: December 1, 2011
• Primary Completion: February 1, 2015
• Study Completion: April 1, 2015
• Last Updated: December 14, 2015

Record last verified: 2015-12

Locations

GB (5)