Early Rehabilitation of COPD Patients in ICU

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00628992
• Other study ID #: 3912
• Status: Terminated
• Phase: N/A
• First received: February 4, 2008
• Last updated: March 26, 2015
• Start date: February 2008
• Est. completion date: September 2011

Study information

• Verified date: March 2015
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: September 2011
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

Other:
• No specific intervention, standard therapy serving as a control group, passive mobilization of the legs
Muscular rehabilitation of the leg
• Electrical stimulation of the thigh
Muscular rehabilitation of the leg
• Cycloergometer training
Muscular rehabilitation of the leg
• Electrical stimulation of the thigh and cycloergometer training
Muscular rehabilitation of the leg

Locations

Country	Name	City	State
France	Service de Médecine Physique et de Réadaptation, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg	Strasbourg
France	Service de Réanimation Médicale, Hôpital Civil, Hôpitaux Universitaires de Strasbourg	Strasbourg
France	Service de Réanimation Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg	Strasbourg
France	Service des Explorations Fonctionnelles Respiratoires, Hôpital Civil, Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number day breathing without assistance during the 28-day study period		during the 28-day study period	No
Secondary	Mortality at day 28 and day 90		Measured within the ICU stay of the patient	No
Secondary	Length of stay in intensive care unit and hospital		Measured within the ICU stay of the patient	No
Secondary	Clinical measurement of muscular strength in lower limbs(day 0-2 and day 28-30)		Measured within the ICU stay of the patient	No