Early Rehabilitation of COPD Patients in ICU

University Hospital, Strasbourg, France

Status: Terminated

Conditions: Chronic Obstructive Pulmonary Disease; Acute Respiratory Failure

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00628992

3912

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 4 patient groups

1

Other group

Treatment:

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

2

Active Comparator group

Treatment:

Other: Electrical stimulation of the thigh

3

Active Comparator group

Treatment:

Other: Cycloergometer training

4

Active Comparator group

Treatment:

Other: Electrical stimulation of the thigh and cycloergometer training