Rehabilitation After Critical Illness Clinical Trial
Official title:
Outpatient Based Physical Rehabilitation for Survivors of Prolonged Critical Illness - a Randomised Controlled Trial
| NCT number | NCT02491021 |
| Other study ID # | 06/Q1402/39 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | July 2, 2015 |
| Last updated | July 7, 2015 |
| Start date | October 2007 |
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.
| Status | Completed |
| Enrollment | 63 |
| Est. completion date | |
| Est. primary completion date | December 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: All patients over the age of 18 - admitted to a single, tertiary centre United Kingdom general intensive care unit (ICU) - Invasively ventilated = 5 days Exclusion Criteria: - 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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital Birmingham NHS Foundation Trust |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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). | At recruitment (within 6 weeks of hospital discharge) and then reassessed 8-10 weeks later | Yes |
| Secondary | 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. | At recruitment (within 6 weeks of hospital discharge) and then reassessed 8-10 weeks later | No |