Exercise After Intensive Care Unit: a Randomised Controlled Trial (REVIVE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Ulster
Sponsor:
Collaborator:
Belfast Health and Social Care Trust
Information provided by (Responsible Party):
Brenda O'Neill, University of Ulster
ClinicalTrials.gov Identifier:
NCT01463579
First received: September 8, 2011
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Critical Illness
Intensive Care
Other: Exercise Programme
Other: Standard Care
Phase 2

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

Resource links provided by NLM:


Further study details as provided by University of Ulster:

Primary Outcome Measures:
  • Physical Functioning subscale of the SF-36 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Physical Functioning Subscale of the SF-36 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Rivermead Mobility Index [ Time Frame: 6 weeks, 6 months ] [ Designated as safety issue: No ]
    Physical Function will also be measured using the Rivermead Mobility Index.

  • Hand Dynamometry [ Time Frame: 6 weeks, 6 months ] [ Designated as safety issue: No ]
    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.

  • The Nine Hole Peg Test [ Time Frame: 6 weeks, 6 months ] [ Designated as safety issue: No ]
    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.

  • Incremental Shuttle Walk Test [ Time Frame: 6 weeks, 6 months ] [ Designated as safety issue: No ]
    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.

  • Functional Limitations Profile [ Time Frame: 6 weeks, 6 months ] [ Designated as safety issue: No ]
    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.

  • other subscales of the SF-36 [ Time Frame: 6 weeks, 6 months ] [ Designated as safety issue: No ]
    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).

  • Hospital Anxiety and Depression Scale [ Time Frame: 6 weeks, 6 months ] [ Designated as safety issue: No ]
    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.

  • 'Readiness to change' questionnaire [ Time Frame: 6 weeks, 6 months ] [ Designated as safety issue: No ]
    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.

  • Chronic Disease Self Efficacy Scale (Exercise component) [ Time Frame: 6 weeks, 6 months ] [ Designated as safety issue: No ]
    The exercise component of the Chronic Disease Self Efficacy Scale will be used to measure self efficacy relating to exercise.

  • The EuroQol-5D [ Time Frame: 6 weeks, 6 months ] [ Designated as safety issue: No ]
    The EuroQol-5D is a useful measure of health related quality of life in a mixed critical care population.

  • Medical Research Council Dyspnoea Scale [ Time Frame: 6 weeks, 6 months ] [ Designated as safety issue: No ]
    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.

  • 'Healthcare Utilisation' Questionnaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Semi-structured Interview [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Patient's perceptions of the exercise programme will be explored.


Estimated Enrollment: 68
Study Start Date: December 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise programme 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 Other: 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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01463579

Contacts
Contact: Dr Brenda O'Neill, PhD, BSc Hons Physiotherapy 028 9036 8812 b.oneill@ulster.ac.uk
Contact: Kathryn McDowell, BSc Hons Physiotherapy 028 90 366432 mcdowell-k3@email.ulster.ac.uk

Locations
United Kingdom
Northern Health and Social Care Trust Recruiting
Antrim, Co. Antrim, United Kingdom, BT41 2RL
Principal Investigator: Dr Paul Johnston, MD         
Belfast Health and Social Care Trust Recruiting
Belfast, Co. Antrim, United Kingdom, BT12 6BA
Principal Investigator: Dr Brian Mullan, MD         
Southern Health and Social Care Trust Recruiting
Craigavon, Co. Armagh, United Kingdom, BT63 5QQ
Principal Investigator: Dr Chris Clarke, MD         
Western Health and Social Care Trust Recruiting
Derry, Co. Londonderry, United Kingdom, BT47 6SB
Principal Investigator: Dr Michaeline Kelly, MD         
South Eastern Health and Social Care Trust Recruiting
Dundonald, Co Down, United Kingdom, BT16 1RH
Principal Investigator: Dr John Trinder, MD         
Sponsors and Collaborators
University of Ulster
Belfast Health and Social Care Trust
Investigators
Principal Investigator: Dr Brenda O'Neill, PhD, BSc Hons Physiotherapy University of Ulster
  More Information

No publications provided

Responsible Party: Brenda O'Neill, Dr Brenda O'Neill, University of Ulster
ClinicalTrials.gov Identifier: NCT01463579     History of Changes
Other Study ID Numbers: 11/0291
Study First Received: September 8, 2011
Last Updated: May 19, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Ulster:
Intensive Care Unit
Critical Illness
Rehabilitation
Exercise Programme

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014