Early Rehabilitation of COPD Patients in ICU

Not Applicable

Terminated

• Conditions: Chronic Obstructive Pulmonary Disease; Acute Respiratory Failure
• Interventions: Other: No specific intervention, standard therapy serving as a control group, passive mobilization of the legs; Other: Electrical stimulation of the thigh; Other: Cycloergometer training; Other: Electrical stimulation of the thigh and cycloergometer training

• Registration Number: NCT00628992
• Lead Sponsor: University Hospital, Strasbourg, France

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-04
• Study First Submitted QC: 2008-02-25
• Study First Posted: 2008-03-05
• Primary Completion: 2008-11
• Study Completion: 2011-09
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-26
• Last Update Posted: 2015-03-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Patient older than 18 years of age
• Chronic obstructive pulmonary disease
• Intubated with mechanical ventilation
• Patients without sedation or catecholamine
• 2 previous spontaneous breathing trial at 24 hour intervals with T-piece having been unsuccessful
• Conscious and cooperative state
• Ability for the patient to sit in a armchair

Exclusion Criteria

• Non chronic obstructive pulmonary disease
• Lack of patient involvement
• Minor Patients
• Patients under guardianship
• Unconscious and non cooperative state
• Patients unable to ride in a wheelchair
• Patients not affiliated with a Social Security System
• Patients under justice safeguard
• Patients under curator ship

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	No specific intervention, standard therapy serving as a control group, passive mobilization of the legs	-
2	Electrical stimulation of the thigh	-
3	Cycloergometer training	-
4	Electrical stimulation of the thigh and cycloergometer training	-

Primary Outcome Measures

Name	Time	Method
Number day breathing without assistance during the 28-day study period	during the 28-day study period

Secondary Outcome Measures

Name	Time	Method
Length of stay in intensive care unit and hospital	Measured within the ICU stay of the patient
Mortality at day 28 and day 90	Measured within the ICU stay of the patient
Clinical measurement of muscular strength in lower limbs(day 0-2 and day 28-30)	Measured within the ICU stay of the patient

Trial Locations

Locations (4)

Service de Réanimation Médicale, Hôpital Civil, Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France

Service de Réanimation Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France

Service des Explorations Fonctionnelles Respiratoires, Hôpital Civil, Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France

Service de Médecine Physique et de Réadaptation, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France