Trials / Terminated
TerminatedNCT00628992
Early Rehabilitation of COPD Patients in ICU
Effects of Early Rehabilitation in Chronic Obstructive Pulmonary Disease Patients Under Mechanical Ventilation for Acute Respiratory Failure in Intensive Care Unit.
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- University Hospital, Strasbourg, France · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Twenty per cent of the intensive care patients mechanically ventilated suffer from chronic obstructive pulmonary disease (COPD). These patients stay longer in Intensive Care which is more costly and they are more prone to nosocomial infection.In addition, they are longer bedridden and they develop muscular weakness.Prolonged inactivity results in respiratory and skeletal muscle weakness which curtails simple daily activity.The principal purpose of this study is to compare two types of muscular rehabilitation (electrical stimulation of the thigh and/or cycloergometer training) to classic passive mobilization of the leg.The second purpose is to analyse the effects of each type of rehabilitation on muscular fiber (structural and functional analysis) by muscular biopsies.Two hundred forty COPD patients admitted in the intensive care unit for acute respiratory failure will be randomized in 4: 1 fashion to receive passive mobilization of the legs(group 1, n=60), electrical stimulation of the thigh (group 2, n=60), cycloergometer training (group 3, n=60) or electrical stimulation of the thigh and cycloergometer training(group 4, n=60).The rehabilitation program will last 4 weeks with 5 sessions per week.In each group of patients, muscular biopsies will be done under local anaesthesia at the beginning and end of the rehabilitation programme and when they are discharged from the service.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | No specific intervention, standard therapy serving as a control group, passive mobilization of the legs | Muscular rehabilitation of the leg |
| OTHER | Electrical stimulation of the thigh | Muscular rehabilitation of the leg |
| OTHER | Cycloergometer training | Muscular rehabilitation of the leg |
| OTHER | Electrical stimulation of the thigh and cycloergometer training | Muscular rehabilitation of the leg |
Timeline
- Start date
- 2008-02-01
- Primary completion
- 2008-11-01
- Completion
- 2011-09-01
- First posted
- 2008-03-05
- Last updated
- 2015-03-27
Locations
4 sites across 1 country: France
Source: ClinicalTrials.gov record NCT00628992. Inclusion in this directory is not an endorsement.