Effect of Electrostimulation in Chronic Obstructive Pulmonary Disease (COPD) (ExaEMS2005)
|ClinicalTrials.gov Identifier: NCT01167283|
Recruitment Status : Completed
First Posted : July 22, 2010
Last Update Posted : August 6, 2010
This study was designed to test the following hypothesis:
To investigate whether COPD muscles can respond to stimuli in terms of changes in fiber-type distribution.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Device: Electrostimulation Device: Sham stimulation||Not Applicable|
Background: Muscle dysfunction is a major problem in chronic obstructive pulmonary disease (COPD). It is characterized by muscle fiber-type redistribution and oxidative stress. Classical training does not improve these features.
Objectives: To investigate whether electrostimulation program following exacerbation can modify muscle structure and function in COPD patients.
Method: We propose to conduct a controlled and randomized clinical trial comparing the efficacy of muscle electrostimulation training of the lower limbs to sham training in 15 patients with COPD. Patients are included in either 6 weeks of electrostimulation training (active treatment group) or 6 weeks of sham electrostimulation. Primary outcomes were changes in muscle structure, muscle oxidative stress and their relationship with quadriceps force and exercise tolerance.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effect of Electromyostimulation in Severe Chronic Obstructive Pulmonary Disease|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||April 2010|
Active Comparator: Electrostimulation
Neuromuscular electrical stimulation
Electrostimulation: 35 Hz, 0.4 ms, 1 h; 5 times/week
Other Name: NMES
Sham Comparator: Sham stimulation
Device: Sham stimulation
Sham stimulation: 1 h; 5 times/week
Other Name: Sham
- Fiber-type distribution [ Time Frame: 6 to 8 weeks ]Typology was evaluated by immunohistochemistry
- Change in the strength of the quadriceps over the 6-week electrostimulation program [ Time Frame: 6 to 8 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01167283
|Principal Investigator:||Olivier OJ Jonquet, PU-PH||Institut National de la Santé Et de la Recherche Médicale, France|