Status:
COMPLETED
Rehabilitation Following Critical Illness
Lead Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Conditions:
Critical Illness Myopathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 qual...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
- 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00976807
Start Date
November 1 2009
End Date
November 1 2012
Last Update
January 6 2015
Active Locations (2)
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1
St.Thomas' Hospital
London, London, United Kingdom, SE1 7EH
2
King's College Hospital
London, London, United Kingdom, SE5 9RS