Critical Illness Clinical Trial
Official title:
Early Exercise in Critically Ill Patients Enhances Short-Term Functional Recovery
Verified date | June 2008 |
Source | Katholieke Universiteit Leuven |
Contact | n/a |
Is FDA regulated | No |
Health authority | Belgium: Institutional Review Board |
Study type | Interventional |
This randomized controlled trial was designed to investigate whether a daily training session using a bedside cycle ergometer, started early in stable critically ill patients with an expected prolonged ICU stay, could induce a beneficial effect on exercise performance, quadriceps force and functional autonomy at ICU and hospital discharge compared to a standard physiotherapy program.
Status | Completed |
Enrollment | 90 |
Est. completion date | February 2007 |
Est. primary completion date | February 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - ICU stay > 5 days - Expected prolonged stay of at least 7 more days - Cardiorespiratory status that allows at least passive exercise therapy Exclusion Criteria: - Persistent or progressive neurological or (neuro)muscular disease - Coagulation disorders (INR > 1.5, [BP] < 50000/mm³) - Intracranial pressure > 20 mmHg - Psychiatric disorders or severe confusion |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Belgium | Department of Rehabilitation Sciences, University Hospitals KULeuven | Leuven | Vlaams-Brabant |
Lead Sponsor | Collaborator |
---|---|
Katholieke Universiteit Leuven | Fund for Scientific Research, Flanders, Belgium |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | six-minute walking distance | hospital discharge | No | |
Secondary | quadriceps force | ICU discharge and hospital discharge | No | |
Secondary | functional status (Berg Balance Scale, Functional Ambulation Categories, SF-36 Physical Function-item) | ICU discharge and hospital discharge | No |
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