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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Critical Illness
- Sponsor
- University of Ulster
- Enrollment
- 60
- Locations
- 5
- Primary Endpoint
- Physical Functioning subscale of the SF-36
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Brenda O'Neill
Dr Brenda O'Neill
University of Ulster
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
Outcomes
Primary Outcomes
Physical Functioning subscale of the SF-36
Time Frame: 6 weeks
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.
Secondary Outcomes
- Physical Functioning Subscale of the SF-36(6 months)
- The EuroQol-5D(6 weeks, 6 months)
- The Nine Hole Peg Test(6 weeks, 6 months)
- Functional Limitations Profile(6 weeks, 6 months)
- Medical Research Council Dyspnoea Scale(6 weeks, 6 months)
- other subscales of the SF-36(6 weeks, 6 months)
- Hospital Anxiety and Depression Scale(6 weeks, 6 months)
- 'Readiness to change' questionnaire(6 weeks, 6 months)
- Hand Dynamometry(6 weeks, 6 months)
- Incremental Shuttle Walk Test(6 weeks, 6 months)
- Chronic Disease Self Efficacy Scale (Exercise component)(6 weeks, 6 months)
- Rivermead Mobility Index(6 weeks, 6 months)
- 'Healthcare Utilisation' Questionnaire(6 months)
- Semi-structured Interview(6 months)