Early Rehabilitation of COPD Patients in ICU

NCT ID: NCT00628992

Last Updated: 2015-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2011-09-30

Brief Summary

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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

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Conditions

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Chronic Obstructive Pulmonary Disease Acute Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type OTHER

No specific intervention, standard therapy serving as a control group, passive mobilization of the legs

Intervention Type OTHER

Muscular rehabilitation of the leg

2

Group Type ACTIVE_COMPARATOR

Electrical stimulation of the thigh

Intervention Type OTHER

Muscular rehabilitation of the leg

3

Group Type ACTIVE_COMPARATOR

Cycloergometer training

Intervention Type OTHER

Muscular rehabilitation of the leg

4

Group Type ACTIVE_COMPARATOR

Electrical stimulation of the thigh and cycloergometer training

Intervention Type OTHER

Muscular rehabilitation of the leg

Interventions

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No specific intervention, standard therapy serving as a control group, passive mobilization of the legs

Muscular rehabilitation of the leg

Intervention Type OTHER

Electrical stimulation of the thigh

Muscular rehabilitation of the leg

Intervention Type OTHER

Cycloergometer training

Muscular rehabilitation of the leg

Intervention Type OTHER

Electrical stimulation of the thigh and cycloergometer training

Muscular rehabilitation of the leg

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vincent CASTELAIN, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpitaux Universitaires de Strasbourg

Locations

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Service de Réanimation Médicale, Hôpital Civil, Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status

Service des Explorations Fonctionnelles Respiratoires, Hôpital Civil, Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status

Service de Médecine Physique et de Réadaptation, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status

Service de Réanimation Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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3912

Identifier Type: -

Identifier Source: org_study_id

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