Critical IllnessPhase 2REVIVENCT01463579
Exercise After Intensive Care Unit: a Randomised Controlled Trial
A Phase 2 study testing Exercise Programme in people with Critical Illness and Intensive Care, run by University of Ulster at 5 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Intensive Care
- What is being tested?
- Exercise Programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- Dec 2011to Apr 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Northern Health and Social Care Trust
Antrim, Co. Antrim, BT41 2RL
Belfast Health and Social Care Trust
Belfast, Co. Antrim, BT12 6BA
Southern Health and Social Care Trust
Craigavon, Co. Armagh, BT63 5QQ
South Eastern Health and Social Care Trust
Dundonald, Co Down, BT16 1RH
Western Health and Social Care Trust
Londonderry, Co. Londonderry, BT47 6SB
About this study
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
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.
Read the 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.
- Conditions
- Critical Illness, Intensive Care
- Being tested
- Exercise Programme, Standard Care
- Keywords
- Intensive Care Unit, Critical Illness, Rehabilitation, Exercise Programme
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise ProgrammeOther
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise programme | Experimental | Not described Receives: Other: Exercise Programme |
| Standard Care | Other | Not described Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (14)
Physical Functioning Subscale of the SF-36
Measured: 6 months
Rivermead Mobility Index
Physical Function will also be measured using the Rivermead Mobility Index.
Measured: 6 weeks, 6 months
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.
Measured: 6 weeks, 6 months
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.
Measured: 6 weeks, 6 months
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.
Measured: 6 weeks, 6 months
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.
Measured: 6 weeks, 6 months
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).
Measured: 6 weeks, 6 months
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.
Measured: 6 weeks, 6 months
'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.
Measured: 6 weeks, 6 months
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.
Measured: 6 weeks, 6 months
The EuroQol-5D
The EuroQol-5D is a useful measure of health related quality of life in a mixed critical care population.
Measured: 6 weeks, 6 months
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.
Measured: 6 weeks, 6 months
'Healthcare Utilisation' Questionnaire
Measured: 6 months
Semi-structured Interview
Patient's perceptions of the exercise programme will be explored.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2011 (estimated)
- Study startDec 2011
- Primary completionFeb 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- Belfast Health and Social Care Trust
- Responsible party
- Principal investigator, Brenda O'Neill, University of Ulster
- Investigators
- Dr Brenda O'Neill, PhD, BSc Hons Physiotherapy, Principal investigator, University of Ulster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01463579
- Sponsor's protocol ID
- 11/0291
- Acronym
- REVIVE
- Status last verified
- Dec 2015
- First submitted
- 8 Sep 2011
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24767671McDowell 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.
PubMed 27852953
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01463579
- Acronym / sponsor ID
- REVIVE / 11/0291
- Conditions
- Critical Illness, Intensive Care
- Keywords
- Intensive Care Unit, Critical Illness, Rehabilitation, Exercise Programme
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- Belfast Health and Social Care Trust
- Study start
- Dec 2011
- Primary completion
- Feb 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 2 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise programme | Experimental | Other: Exercise Programme |
| Standard Care | Other | Other: Standard Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise ProgrammePatients 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. | Other | Exercise programme |
| Standard CareFollowing 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. | Other | Standard Care |
Primary outcome
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.
14 secondary outcomes
Physical Functioning Subscale of the SF-36
Time frame: 6 months
Rivermead Mobility Index
Time frame: 6 weeks, 6 months
Hand Dynamometry
Time frame: 6 weeks, 6 months
The Nine Hole Peg Test
Time frame: 6 weeks, 6 months
Incremental Shuttle Walk Test
Time frame: 6 weeks, 6 months
Functional Limitations Profile
Time frame: 6 weeks, 6 months
other subscales of the SF-36
Time frame: 6 weeks, 6 months
Hospital Anxiety and Depression Scale
Time frame: 6 weeks, 6 months
'Readiness to change' questionnaire
Time frame: 6 weeks, 6 months
Chronic Disease Self Efficacy Scale (Exercise component)
Time frame: 6 weeks, 6 months
The EuroQol-5D
Time frame: 6 weeks, 6 months
Medical Research Council Dyspnoea Scale
Time frame: 6 weeks, 6 months
'Healthcare Utilisation' Questionnaire
Time frame: 6 months
Semi-structured Interview
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
- Background: PubMed 24767671O'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.
- Derived from this study: PubMed 27852953McDowell 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Brenda O'Neill, PhD, BSc Hons Physiotherapy principal investigator
University of Ulster
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Exercise Programme in people with Critical Illness and Intensive Care, run by University of Ulster at 5 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Functioning subscale of the SF-36 (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01463579, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2015.