Skip to main content
OpenTrials
Completed

NCT Number: NCT01463579

Exercise After Intensive Care Unit: a Randomised Controlled Trial

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Critical Illness Disease Attributes Intensive Care Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Northern Health and Social Care Trust, Antrim, Co. Antrim, United Kingdom

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  1. Physical Functioning Subscale of the SF-36

    Time frame: 6 months

  2. Rivermead Mobility Index

    Time frame: 6 weeks, 6 months

    Physical Function will also be measured using the Rivermead Mobility Index.

  3. Hand Dynamometry

    Time frame: 6 weeks, 6 months

    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.

  4. The Nine Hole Peg Test

    Time frame: 6 weeks, 6 months

    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.

  5. Incremental Shuttle Walk Test

    Time frame: 6 weeks, 6 months

    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. Functional Limitations Profile

    Time frame: 6 weeks, 6 months

    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.

  7. other subscales of the SF-36

    Time frame: 6 weeks, 6 months

    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).

  8. Hospital Anxiety and Depression Scale

    Time frame: 6 weeks, 6 months

    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.

  9. 'Readiness to change' questionnaire

    Time frame: 6 weeks, 6 months

    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.

  10. Chronic Disease Self Efficacy Scale (Exercise component)

    Time frame: 6 weeks, 6 months

    The exercise component of the Chronic Disease Self Efficacy Scale will be used to measure self efficacy relating to exercise.

  11. The EuroQol-5D

    Time frame: 6 weeks, 6 months

    The EuroQol-5D is a useful measure of health related quality of life in a mixed critical care population.

  12. Medical Research Council Dyspnoea Scale

    Time frame: 6 weeks, 6 months

    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.

  13. 'Healthcare Utilisation' Questionnaire

    Time frame: 6 months

  14. Semi-structured Interview

    Time frame: 6 months

    Patient's perceptions of the exercise programme will be explored.

Sponsors and collaborators

Lead sponsor

University of Ulster

Other

Collaborators

  • Belfast Health and Social Care Trust

Registry information

Official study 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

Acronym: REVIVE

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Nov 2, 2011
Registry last updated
Dec 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.