Rehabilitation After Critical IllnessPhase 2NCT02491021
Outpatient Based Physical Rehabilitation for Survivors of Prolonged Critical Illness
A Phase 2 study testing Rehabilitation Class in people with Rehabilitation After Critical Illness, run by University Hospital Birmingham NHS Foundation Trust.
Trial summary
Admission to an intensive care unit (ICU) due to illness has been shown to have a dramatic effect on the human body and mind. Following discharge from an ICU, patients suffer from varying degrees of weakness and muscle wasting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rehabilitation After Critical Illness
- What is being tested?
- Rehabilitation Class
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- Oct 2007to Dec 2011
- 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
- All patients over the age of 18
- admitted to a single, tertiary centre United Kingdom general intensive care unit (ICU)
- Invasively ventilated ≥ 5 days
Who cannot join
- Physical condition resulting in an inability to perform a cardio-pulmonary exercise test (CPET) or to participate in the rehabilitation classes,
- Psychiatric condition or impairment not allowing informed consent or compliance with the rehabilitation programme,
- Participation in an alternative rehabilitation programme,
- Terminal illness
- Poorly controlled cardio-respiratory disease
About this study
Official title: Outpatient Based Physical Rehabilitation for Survivors of Prolonged Critical Illness - a Randomised Controlled Trial
Admission to an intensive care unit (ICU) due to illness has been shown to have a dramatic effect on the human body and mind. Following discharge from an ICU, patients suffer from varying degrees of weakness and muscle wasting. It can take many months before their strength returns to something like before they were ill. This weakness can have important consequences on an individual, affecting their ability to perform routine tasks (e.g. housework, shopping), and whether they can return to work or not. Not surprisingly, this inability to perform activities they used to do prior to their illness can have knock on effects on their mental well being and confidence.
What the investigators hope to see through this study is whether or not patients can recover their ability to perform exercise more quickly following an ICU admission if they undergo an exercise-based rehabilitation programme. The investigators also hope to see whether taking part in a rehabilitation programme has any affect on physical and mental well being.
Read more
The investigators hope to use a simple exercise test on a bicycle to assess subjects ability to exercise shortly after leaving hospital. We will then repeat the test after a period of physiotherapy lead rehabilitation to see if they have received any benefit from the programme. The investigators hope to show that by undergoing an exercise-based rehabilitation programme subjects will recover their ability to exercise more quickly than those who do not.
By means of questionnaires the investigators hope to see what effect the rehabilitation programme has had on participants physical and mental well being.
- Conditions
- Rehabilitation After Critical Illness
- Being tested
- Rehabilitation Class
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation ClassOther
A 6 week programme of exercise and education in an out patient setting
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Active comparator | Treatment Group (TG) The TG underwent a 7-week outpatient rehabilitation programme comprising both exercise and education sessions under the direct supervision of the physiotherapy team. The exercise intervention was 20 minutes, 3x/week (1 supervised, 2 self directed) titrated to a specific intensity based on risk stratification - highvs low risk). The intervention also included 6 x 1 hour education sessions. Receives: Other: Rehabilitation Class |
| Control Group | No intervention | Control Group (CG) The CG received physiotherapy, exercises and education as per current standards of practice in our institution up until hospital discharge. Following discharge no further specific input or education was provided. Participants were contacted at least once during the study period to check on their general well being and to encourage attendance at the second assessment by the physiotherapy team. In line with the ethical requirements for the study, all control subjects were offered the chance to participate in the rehabilitation programme once their trial participation was completed following second assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiopulmonary Exercise Testing
Primary outcome was the change in exercise capacity measured by changes in peak VO2 and anaerobic threshold (AT) assessed using cardio-pulmonary exercise testing (CPET).
Measured: At recruitment (within 6 weeks of hospital discharge) and then reassessed 8-10 weeks later
Secondary outcomes (1)
Short Form 36 Health Questionnaire
Secondary outcome measures were changes in health related Quality of life (QoL). assessed using the Medical Outcome Study Short Form-36 questionnaire Version 2 (SF36v2). Subjects were asked to answer questions based on a 2-week recall period.
Measured: At recruitment (within 6 weeks of hospital discharge) and then reassessed 8-10 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2015 (estimated)
- Study startOct 2007
- Primary completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rehabilitation After 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
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Birmingham NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David McWilliams, University Hospital Birmingham NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02491021
- Sponsor's protocol ID
- 06/Q1402/39
- Status last verified
- Jul 2015
- First submitted
- 2 Jul 2015
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Based Physical Rehabilitation for Survivors of Prolonged Critical Illness - a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02491021
- Acronym / sponsor ID
- 06/Q1402/39
- Conditions
- Rehabilitation After Critical Illness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University Hospital Birmingham NHS Foundation TrustUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Dec 2011 (actual)
- First posted
- 7 Jul 2015 (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.
Admission to an intensive care unit (ICU) due to illness has been shown to have a dramatic effect on the human body and mind. Following discharge from an ICU, patients suffer from varying degrees of weakness and muscle wasting. It can take many months before their strength returns to something like before they were ill. This weakness can have important consequences on an individual, affecting their ability to perform routine tasks (e.g. housework, shopping), and whether they can return to work or not. Not surprisingly, this inability to perform activities they used to do prior to their illness can have knock on effects on their mental well being and confidence.
What the investigators hope to see through this study is whether or not patients can recover their ability to perform exercise more quickly following an ICU admission if they undergo an exercise-based rehabilitation programme. The investigators also hope to see whether taking part in a rehabilitation programme has any affect on physical and mental well being.
The investigators hope to use a simple exercise test on a bicycle to assess subjects ability to exercise shortly after leaving hospital. We will then repeat the test after a period of physiotherapy lead rehabilitation to see if they have received any benefit from the programme. The investigators hope to show that by undergoing an exercise-based rehabilitation programme subjects will recover their ability to exercise more quickly than those who do not.
By means of questionnaires the investigators hope to see what effect the rehabilitation programme has had on participants physical and mental well being.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Active comparator | Other: Rehabilitation ClassTreatment Group (TG) The TG underwent a 7-week outpatient rehabilitation programme comprising both exercise and education sessions under the direct supervision of the physiotherapy team. The exercise intervention was 20 minutes, 3x/week (1 supervised, 2 self directed) titrated to a specific intensity based on risk stratification - highvs low risk). The intervention also included 6 x 1 hour education sessions. |
| Control Group | No intervention | –Control Group (CG) The CG received physiotherapy, exercises and education as per current standards of practice in our institution up until hospital discharge. Following discharge no further specific input or education was provided. Participants were contacted at least once during the study period to check on their general well being and to encourage attendance at the second assessment by the physiotherapy team. In line with the ethical requirements for the study, all control subjects were offered the chance to participate in the rehabilitation programme once their trial participation was completed following second assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients over the age of 18
- admitted to a single, tertiary centre United Kingdom general intensive care unit (ICU)
- Invasively ventilated ≥ 5 days
Key exclusion criteria (5 listed)
- Physical condition resulting in an inability to perform a cardio-pulmonary exercise test (CPET) or to participate in the rehabilitation classes,
- Psychiatric condition or impairment not allowing informed consent or compliance with the rehabilitation programme,
- Participation in an alternative rehabilitation programme,
- Terminal illness
- Poorly controlled cardio-respiratory disease
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 |
|---|---|---|
| Rehabilitation ClassA 6 week programme of exercise and education in an out patient setting | Other | Treatment Group |
Primary outcome
Cardiopulmonary Exercise Testing
Time frame: At recruitment (within 6 weeks of hospital discharge) and then reassessed 8-10 weeks later
Primary outcome was the change in exercise capacity measured by changes in peak VO2 and anaerobic threshold (AT) assessed using cardio-pulmonary exercise testing (CPET).
1 secondary outcome
Short Form 36 Health Questionnaire
Time frame: At recruitment (within 6 weeks of hospital discharge) and then reassessed 8-10 weeks later
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 8 Jul 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rehabilitation Class in people with Rehabilitation After Critical Illness, run by University Hospital Birmingham NHS Foundation Trust.
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 3 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 8 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Cardiopulmonary Exercise Testing (time frame: At recruitment (within 6 weeks of hospital discharge) and then reassessed 8-10 weeks later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2015.