Clinical Trials Directory

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

TypeNameDescription
OTHERNo specific intervention, standard therapy serving as a control group, passive mobilization of the legsMuscular rehabilitation of the leg
OTHERElectrical stimulation of the thighMuscular rehabilitation of the leg
OTHERCycloergometer trainingMuscular rehabilitation of the leg
OTHERElectrical stimulation of the thigh and cycloergometer trainingMuscular 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.