Early Rehabilitation of COPD Patients in ICU

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00628992
First received: February 4, 2008
Last updated: September 15, 2011
Last verified: September 2011
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


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: March 2013
Estimated Primary Completion Date: March 2013 (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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
Service de Réanimation Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67098
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, 67091
Service de Médecine Physique et de Réadaptation, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67098
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Vincent CASTELAIN, MD Hôpitaux Universitaires de Strasbourg
  More Information

No publications provided

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00628992     History of Changes
Other Study ID Numbers: 3912
Study First Received: February 4, 2008
Last Updated: September 15, 2011
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Strasbourg, France:
COPD: chronic obstructive pulmonary disease and acute respiratory failure

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Respiratory Distress Syndrome, Adult
Lung Diseases, Obstructive
Respiratory Insufficiency
Respiratory Tract Diseases
Respiration Disorders

ClinicalTrials.gov processed this record on August 26, 2014