Early Rehabilitation of COPD Patients in ICU - Full Text View

Sponsored by:	University Hospital, Strasbourg, France
Information provided by:	University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:	NCT00628992

Purpose

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.

Condition	Intervention
Chronic Obstructive Pulmonary Disease Acute Respiratory Failure	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

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Rehabilitation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	Effects of Early Rehabilitation in Chronic Obstructive Pulmonary Disease Patients Under Mechanical Ventilation for Acute Respiratory Failure in Intensive Care Unit.

Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:

Number day breathing without assistance during the 28-day study period [ Time Frame: during the 28-day study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mortality at day 28 and day 90 [ Time Frame: Measured within the ICU stay of the patient ] [ Designated as safety issue: No ]
Length of stay in intensive care unit and hospital [ Time Frame: Measured within the ICU stay of the patient ] [ Designated as safety issue: No ]
Clinical measurement of muscular strength in lower limbs(day 0-2 and day 28-30) [ Time Frame: Measured within the ICU stay of the patient ] [ Designated as safety issue: No ]

Estimated Enrollment:	240
Study Start Date:	February 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1	Other: No specific intervention, standard therapy serving as a control group, passive mobilization of the legs Muscular rehabilitation of the leg
2: Active Comparator	Other: Electrical stimulation of the thigh Muscular rehabilitation of the leg
3: Active Comparator	Other: Cycloergometer training Muscular rehabilitation of the leg
4: Active Comparator	Other: Electrical stimulation of the thigh and cycloergometer training Muscular rehabilitation of the leg

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00628992

Contacts

Contact: Vincent CASTELAIN, MD

33.3.88.12.79.15

vincent.castelain@chru-strasbourg.fr

Locations

France
Service de Réanimation Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg	Recruiting
STRASBOURG, France, 67098
Contact: Vincent CASTELAIN, MD 33.3.88.12.79.15 vincent.castelain@chru-strasbourg.fr
Principal Investigator: Vincent CASTELAIN, MD
Sub-Investigator: Albert JEAGER, MD
Sub-Investigator: Francis SCHNEIDER, MD
Service de Réanimation Médicale, Hôpital Civil, Hôpitaux Universitaires de Strasbourg	Recruiting
STRASBOURG, France, 67091
Contact: Philippe SAUDER, MD 33.3.88.11.61.46 philippe.sauder@chru-strasbourg.fr
Sub-Investigator: Philippe SAUDER, MD
Service des Explorations Fonctionnelles Respiratoires, Hôpital Civil, Hôpitaux Universitaires de Strasbourg	Not yet recruiting
STRASBOURG, France, 67091
Contact: Ruddy RICHARD, MD 33.3.88.11.65.61 ruddy.richard@chru-strasbourg.fr
Sub-Investigator: Joffrey ZOLL
Sub-Investigator: Frédéric DAUSSIN
Service de Médecine Physique et de Réadaptation, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg	Recruiting
STRASBOURG, France, 67098
Contact: Marie-Eve ISNER-HOROBETI, MD 33.3.88.12.79.29 marie-eve.isner@chru-strasbourg.fr
Sub-Investigator: Marie-Eve ISNER-HOROBETI, MD
Sub-Investigator: Jehan LECOCQ, MD
Sub-Investigator: Pierre FROEHLIG, MD

Sponsors and Collaborators

University Hospital, Strasbourg, France

Investigators

Principal Investigator:

Vincent CASTELAIN, MD

Hôpitaux Universitaires de Strasbourg

More Information

Responsible Party:	University Hospital, Strasbourg, France ( Emmanual LAVOUE, Directeur Adjoint de la DRCI )
Study ID Numbers:	3912
Study First Received:	February 4, 2008
Last Updated:	November 17, 2008
ClinicalTrials.gov Identifier:	NCT00628992
Health Authority:	France: Ministry of Health

Keywords provided by University Hospital, Strasbourg, France:

COPD: chronic obstructive pulmonary disease and acute respiratory failure

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Insufficiency
Respiratory Tract Diseases
Lung Diseases

Respiratory Distress Syndrome, Adult
Respiration Disorders
Acute respiratory distress syndrome
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on January 16, 2009