Clinical trial NCT02491021: Outpatient Based Physical Rehabilitation for Survivors of Prolonged Critical Illness
Official title: Outpatient Based Physical Rehabilitation for Survivors of Prolonged Critical Illness - a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rehabilitation After Critical Illness
Lead sponsor: University Hospital Birmingham NHS Foundation Trust
Sponsor class: OTHER
First posted: 2015-07-07
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Cardiopulmonary Exercise Testing
timeFrame: At recruitment (within 6 weeks of hospital discharge) and then reassessed 8-10 weeks later
Secondary outcomes:
measure: Short Form 36 Health Questionnaire
timeFrame: At recruitment (within 6 weeks of hospital discharge) and then reassessed 8-10 weeks later
Other outcomes:
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Study officials:
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