Clinical trial NCT00628992: Early Rehabilitation of COPD Patients in ICU
Official title: Effects of Early Rehabilitation in Chronic Obstructive Pulmonary Disease Patients Under Mechanical Ventilation for Acute Respiratory Failure in Intensive Care Unit.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Acute Respiratory Failure
Keywords: COPD: chronic obstructive pulmonary disease and acute respiratory failure
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2008-03-05
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number day breathing without assistance during the 28-day study period
timeFrame: during the 28-day study period
Secondary outcomes:
measure: Mortality at day 28 and day 90
timeFrame: Measured within the ICU stay of the patient
measure: Length of stay in intensive care unit and hospital
timeFrame: Measured within the ICU stay of the patient
measure: Clinical measurement of muscular strength in lower limbs(day 0-2 and day 28-30)
timeFrame: Measured within the ICU stay of the patient
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Réanimation Médicale, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
city: Strasbourg
country: France
facility: Service des Explorations Fonctionnelles Respiratoires, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
city: Strasbourg
country: France
facility: Service de Médecine Physique et de Réadaptation, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
city: Strasbourg
country: France
facility: Service de Réanimation Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Vincent CASTELAIN, MD
role: PRINCIPAL_INVESTIGATOR
References: