Effect of Electrostimulation in Chronic Obstructive Pulmonary Disease (COPD) (ExaEMS2005)

August 5, 2010 updated by: Institut National de la Santé Et de la Recherche Médicale, France

Effect of Electromyostimulation in Severe Chronic Obstructive Pulmonary Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Electrostimulation
Neuromuscular electrical stimulation
Device: Electrostimulation
Electrostimulation: 35 Hz, 0.4 ms, 1 h; 5 times/week
Other Names:
  • NMES
Sham Comparator: Sham stimulation
Device: Sham stimulation
Sham stimulation: 1 h; 5 times/week
Other Names:
  • Sham

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fiber-type distribution
Time Frame: 6 to 8 weeks
Typology was evaluated by immunohistochemistry
6 to 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in the strength of the quadriceps over the 6-week electrostimulation program
Time Frame: 6 to 8 weeks
6 to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Collaborators

Centre Hospitalier Régional Universitaire Montpellier

Investigators

  • Principal Investigator: Olivier OJ Jonquet, PU-PH, Institut National de la Santé Et de la Recherche Médicale, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

July 13, 2010

First Submitted That Met QC Criteria

July 20, 2010

First Posted (Estimate)

July 22, 2010

Study Record Updates

Last Update Posted (Estimate)

August 6, 2010

Last Update Submitted That Met QC Criteria

August 5, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APARD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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