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Clinical Trials/NCT01167283
NCT01167283CompletedNot Applicable

Effect of Electromyostimulation in Severe Chronic Obstructive Pulmonary Disease

Institut National de la Santé Et de la Recherche Médicale, France0 sites15 target enrollmentStarted: July 1, 2006Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
15
Primary Endpoint
Fiber-type distribution

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Masking
Single (Participant)

Eligibility Criteria

Ages
50 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Fiber-type distribution

Time Frame: 6 to 8 weeks

Typology was evaluated by immunohistochemistry

Secondary Outcomes

  • Change in the strength of the quadriceps over the 6-week electrostimulation program(6 to 8 weeks)

Investigators

Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Sponsor Class
Other Gov

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