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Outpatient Based Physical Rehabilitation for Survivors of Prolonged Critical Illness

Phase 2
Completed
Conditions
Rehabilitation After Critical Illness
Interventions
Other: Rehabilitation Class
Registration Number
NCT02491021
Lead Sponsor
University Hospital Birmingham NHS Foundation Trust
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
63
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Treatment GroupRehabilitation 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.
Primary Outcome Measures
NameTimeMethod
Cardiopulmonary Exercise TestingAt 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).

Secondary Outcome Measures
NameTimeMethod
Short Form 36 Health QuestionnaireAt recruitment (within 6 weeks of hospital discharge) and then reassessed 8-10 weeks later

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.

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