Critical Illness MyopathyNCT00976807
Rehabilitation Following Critical Illness
A study testing Pulmonary Rehabilitation in people with Critical Illness Myopathy, run by Guy's and St Thomas' NHS Foundation Trust at 2 sites in United Kingdom.
Trial summary
The principal research question to be answered by this study is whether an exercise based rehabilitative intervention following critical illness can generate improvements in exercise capacity and quality of life beyond current (usual) care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness Myopathy
- What is being tested?
- Pulmonary Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Nov 2009to Nov 2012
- Phase
- Interventional
- 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 AND admitted to critical care unit
- Ventilated >48-hours (via endotracheal tube) OR received continuous non- invasive ventilation (NIV)/non-invasive continuous positive airways pressure (CPAP)
- Admitted to ICU > 48-hours and evidence of SIRS
- Glasgow Coma Score (GCS) 15 (of 15) AND Abbreviated Mini-Mental Test Score (AMMTS) >/= 8 (of 10) on enrolment into rehabilitation programme
- Mobilising on ward to a degree sufficient as to begin a majority of proposed exercises. Clinical stability for observed exercise as judged by trial team is a prerequisite.
- Participant willingness to complete a programme of exercise based therapy aimed at reducing weakness and shortness of breath: subjective weakness or dyspnoea relative to their pre-admission state is implicit
Who cannot join
- Patients referred for terminal care or prognosis likely to be less than 12-months
- Unstable coronary artery syndrome
- Limb amputation (given special requirement for orthotics/rehabilitation)
- Critical peripheral vascular disease awaiting re-vascularisation procedure (or claudication distance <100 metres)
- Stroke with hemiparesis (likely need for specialised rehabilitation/stay on stroke unit)
- Severe, disabling locomotor problem or severe burns, which prevent effective participation in the exercises contained in the rehabilitation programme.
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- Psychiatric disease necessitating anti-psychotic medication, deliberate drug overdose as the admitting ICU indication, ongoing treatment for drug or alcohol addiction, persons of no fixed abode post-discharge
- Patients undergoing renal haemodialysis (given the associated commitment to outpatient attendance)
- Extra contractual ICU referral (only if distance greater than suitable for twice weekly travel)
- Additional exclusion criteria for muscle biopsy samples:
- Coagulopathy e.g. warfarin use
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
St.Thomas' Hospital
London, London, SE1 7EH
King's College Hospital
London, London, SE5 9RS
About this study
Official title: A Randomised Controlled Trial of Rehabilitation Following Critical Illness: A Short Term Feasibility and Follow-Up Pilot Study
The principal research question to be answered by this study is whether an exercise based rehabilitative intervention following critical illness can generate improvements in exercise capacity and quality of life beyond current (usual) care. The investigators will also aim to demonstrate that such an intervention is both practical and cost-effective.
Read the detailed description
Advances in medicine mean that an increasing number of critically ill people, including those with severe pneumonia (lung infection), chronic obstructive pulmonary disease (also known as emphysema or chronic bronchitis) or the "acute respiratory distress syndrome", survive admission to the hospital intensive care unit. Survivors report health problems such as breathlessness and weakness long after discharge. In a study monitoring over 800 patients discharged from an intensive care ward, over half required some form of caregiver assistance after 1-year.
Whilst on intensive care, patients usually require help to breathe from a ventilator machine and become immobilised. This leads to weak breathing muscles in three quarters of patients, as well as weak and wasted arm and leg muscles. Survivors struggle to regain their previous level of daily activity and function, limited by shortness of breath, muscle weakness and tiredness. It is recognised that people with chronic lung problems, such as chronic obstructive pulmonary disease, face similar problems. In this condition, exercise based therapy has been shown to improve muscle strength, walking ability, shortness of breath, and importantly quality of life.
Given these experiences, a new trial will evaluate a novel programme of exercise-based rehabilitation training in patients discharged from intensive care. The programme will last for 8-weeks and will use exercises designed to correct the breathing and limb muscle weakness, as well as education to help patients cope more effectively. The programme will begin as soon as possible following discharge from hospital and will be conducted on a mostly outpatient basis until the course is completed. By speeding the recovery of strength and activity, it is anticipated that quality of life will be improved, which this trial will attempt to measure.
The rehabilitation programme will include aerobic cardiovascular, and upper and lower limb strengthening exercises, in addition to relevant education sessions.
- Conditions
- Critical Illness Myopathy
- Being tested
- Pulmonary Rehabilitation
- Keywords
- critical care, intensive care, weakness, myopathy, paresis, rehabilitation
- Medical subject headings
- Asthenia, Muscular Diseases, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary RehabilitationOther
Eight week programme of twice-weekly (sixteen sessions) supervised exercise and education sessions. Exercise will include aerobic cardiovascular and upper and lower limb strengthening exercises. Each session will comprise a warm-up period, followed by individualised exercises, and completed with a cool-down, and last approximately 40minutes.
Aerobic exercise will be prescribed based on the results of walking tests and include walking, step-ups, cycling, and strength prescription according to the repetition maximum principle. Patients will complete three sets using this weight.
Furthermore Borg scores will be used within each session to guide and direct exercise intensity. A home exercise programme will also be designed and accompanied by a manual detailing the individual warm-up, exercises and cool-down, and diary sections to record independent activity.
Each session will also include an education session where relevant.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Intervention | Experimental | Pulmonary Rehabilitation Receives: Other: Pulmonary Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental Shuttle Walk Test
Measured: Eight weeks
Secondary outcomes (1)
Health Related Quality of Life
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2009 (estimated)
- Study startNov 2009
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical Illness MyopathyStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bronwen Connolly, Guy's and St Thomas' NHS Foundation Trust
- Investigators
- Nicholas Hart, BSc (Hons), MBBS, MRCP, PhD, Study director, St.Thomas' Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00976807
- Sponsor's protocol ID
- RJ1 09/N153
- Status last verified
- Jan 2015
- First submitted
- 11 Sep 2009
- Last updated
- 6 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Connolly B, Thompson A, Douiri A, Moxham J, Hart N. Exercise-based rehabilitation after hospital discharge for survivors of critical illness with intensive care unit-acquired weakness: A pilot feasibility trial. J Crit Care. 2015 Jun;30(3):589-98. doi: 10.1016/j.jcrc.2015.02.002. Epub 2015 Feb 7.
PubMed 25703957
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Rehabilitation Following Critical Illness: A Short Term Feasibility and Follow-Up Pilot Study
- ClinicalTrials.gov ID
- NCT00976807
- Acronym / sponsor ID
- RJ1 09/N153
- Conditions
- Critical Illness Myopathy
- Keywords
- critical care, intensive care, weakness, myopathy, paresis, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 14 Sep 2009 (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 principal research question to be answered by this study is whether an exercise based rehabilitative intervention following critical illness can generate improvements in exercise capacity and quality of life beyond current (usual) care. The investigators will also aim to demonstrate that such an intervention is both practical and cost-effective.
Detailed description
Advances in medicine mean that an increasing number of critically ill people, including those with severe pneumonia (lung infection), chronic obstructive pulmonary disease (also known as emphysema or chronic bronchitis) or the "acute respiratory distress syndrome", survive admission to the hospital intensive care unit. Survivors report health problems such as breathlessness and weakness long after discharge. In a study monitoring over 800 patients discharged from an intensive care ward, over half required some form of caregiver assistance after 1-year.
Whilst on intensive care, patients usually require help to breathe from a ventilator machine and become immobilised. This leads to weak breathing muscles in three quarters of patients, as well as weak and wasted arm and leg muscles. Survivors struggle to regain their previous level of daily activity and function, limited by shortness of breath, muscle weakness and tiredness. It is recognised that people with chronic lung problems, such as chronic obstructive pulmonary disease, face similar problems. In this condition, exercise based therapy has been shown to improve muscle strength, walking ability, shortness of breath, and importantly quality of life.
Given these experiences, a new trial will evaluate a novel programme of exercise-based rehabilitation training in patients discharged from intensive care. The programme will last for 8-weeks and will use exercises designed to correct the breathing and limb muscle weakness, as well as education to help patients cope more effectively. The programme will begin as soon as possible following discharge from hospital and will be conducted on a mostly outpatient basis until the course is completed. By speeding the recovery of strength and activity, it is anticipated that quality of life will be improved, which this trial will attempt to measure.
The rehabilitation programme will include aerobic cardiovascular, and upper and lower limb strengthening exercises, in addition to relevant education sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Intervention | Experimental | Other: Pulmonary RehabilitationPulmonary Rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age >18 years AND admitted to critical care unit
- Ventilated >48-hours (via endotracheal tube) OR received continuous non- invasive ventilation (NIV)/non-invasive continuous positive airways pressure (CPAP)
- Admitted to ICU > 48-hours and evidence of SIRS
- Glasgow Coma Score (GCS) 15 (of 15) AND Abbreviated Mini-Mental Test Score (AMMTS) >/= 8 (of 10) on enrolment into rehabilitation programme
- Mobilising on ward to a degree sufficient as to begin a majority of proposed exercises. Clinical stability for observed exercise as judged by trial team is a prerequisite.
Key exclusion criteria (11 listed)
- Patients referred for terminal care or prognosis likely to be less than 12-months
- Unstable coronary artery syndrome
- Limb amputation (given special requirement for orthotics/rehabilitation)
- Critical peripheral vascular disease awaiting re-vascularisation procedure (or claudication distance <100 metres)
- Stroke with hemiparesis (likely need for specialised rehabilitation/stay on stroke unit)
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 |
|---|---|---|
| Pulmonary RehabilitationEight week programme of twice-weekly (sixteen sessions) supervised exercise and education sessions. Exercise will include aerobic cardiovascular and upper and lower limb strengthening exercises. Each session will comprise a warm-up period, followed by individualised exercises, and completed with a cool-down, and last approximately 40minutes. Aerobic exercise will be prescribed based on the results of walking tests and include walking, step-ups, cycling, and strength prescription according to the repetition maximum principle. Patients will complete three sets using this weight. Furthermore Borg scores will be used within each session to guide and direct exercise intensity. A home exercise programme will also be designed and accompanied by a manual detailing the individual warm-up, exercises and cool-down, and diary sections to record independent activity. Each session will also include an education session where relevant. | Other | Intervention |
Primary outcome
Incremental Shuttle Walk Test
Time frame: Eight weeks
1 secondary outcome
Health Related Quality of Life
Time frame: Eight weeks
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 6 Jan 2015.
- Derived from this study: PubMed 25703957Connolly B, Thompson A, Douiri A, Moxham J, Hart N. Exercise-based rehabilitation after hospital discharge for survivors of critical illness with intensive care unit-acquired weakness: A pilot feasibility trial. J Crit Care. 2015 Jun;30(3):589-98. doi: 10.1016/j.jcrc.2015.02.002. Epub 2015 Feb 7.
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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.
Nicholas Hart, BSc (Hons), MBBS, MRCP, PhD study director
St.Thomas' Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Rehabilitation in people with Critical Illness Myopathy, run by Guy's and St Thomas' NHS Foundation Trust at 2 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 6 inclusion and 11 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 6 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
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?
Incremental Shuttle Walk Test (time frame: Eight 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 NCT00976807, which also lists 1 linked publication.
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 6 Jan 2015.