Early Rehabilitation of COPD Patients in ICU

Sponsor

University Hospital, Strasbourg, France (Other)

Overall Status

Terminated

CT.gov ID

NCT00628992

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

1.3

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effects of Early Rehabilitation in Chronic Obstructive Pulmonary Disease Patients Under Mechanical Ventilation for Acute Respiratory Failure in Intensive Care Unit.

Study Start Date :

Feb 1, 2008

Actual Primary Completion Date :

Nov 1, 2008

Actual Study Completion Date :

Sep 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Number day breathing without assistance during the 28-day study period [during the 28-day study period]

Secondary Outcome Measures

Mortality at day 28 and day 90 [Measured within the ICU stay of the patient]
Length of stay in intensive care unit and hospital [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	Service de Réanimation Médicale, Hôpital Civil, Hôpitaux Universitaires de Strasbourg	Strasbourg	France	67091
2	Service des Explorations Fonctionnelles Respiratoires, Hôpital Civil, Hôpitaux Universitaires de Strasbourg	Strasbourg	France	67091
3	Service de Médecine Physique et de Réadaptation, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg	Strasbourg	France	67098
4	Service de Réanimation Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg	Strasbourg	France	67098