Early Rehabilitation of COPD Patients in ICU

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

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Obstructive Pulmonary Disease; Acute Respiratory Failure
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67091
    • Service de Réanimation Médicale, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
  • Strasbourg, France, 67091
    • Service des Explorations Fonctionnelles Respiratoires, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
  • Strasbourg, France, 67098
    • Service de Médecine Physique et de Réadaptation, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
  • Strasbourg, France, 67098
    • Service de Réanimation Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 2	Other: Electrical stimulation of the thigh; Muscular rehabilitation of the leg
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: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number day breathing without assistance during the 28-day study period	during the 28-day study period

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Vincent CASTELAIN, MD, Hôpitaux Universitaires de Strasbourg

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: February 4, 2008
• First Submitted That Met QC Criteria: February 25, 2008
• First Posted (Estimate): March 5, 2008

Study Record Updates

• Last Update Posted (Estimate): March 27, 2015
• Last Update Submitted That Met QC Criteria: March 26, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: COPD: chronic obstructive pulmonary disease and acute respiratory failure
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency; Respiratory Distress Syndrome
• Other Study ID Numbers: 3912