Effect of Electrostimulation in Chronic Obstructive Pulmonary Disease (COPD)

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Device: Electrostimulation; Device: Sham stimulation

• Registration Number: NCT01167283
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2006-07
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2010-07
• Study First Submitted: 2010-07-13
• Study First Submitted QC: 2010-07-20
• Study First Posted: 2010-07-22
• Last Update Submitted: 2010-08-05
• Last Update Posted: 2010-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• COPD patients during or after exacerbation

Exclusion Criteria

• Comorbidities that could limit exercise training
• Obesity (body mass index [BMI] > 30 kg/m²)
• Neuromuscular disease
• Pacemaker implantation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electrostimulation	Electrostimulation	Neuromuscular electrical stimulation
Sham stimulation	Sham stimulation	Sham stimulation

Primary Outcome Measures

Name	Time	Method
Fiber-type distribution	6 to 8 weeks	Typology was evaluated by immunohistochemistry

Secondary Outcome Measures

Name	Time	Method
Change in the strength of the quadriceps over the 6-week electrostimulation program	6 to 8 weeks