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

This study has been completed.
Sponsor:
Collaborator:
Centre Hospitalier Régional Universitaire Montpellier
Information provided by:
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01167283
First received: July 13, 2010
Last updated: August 5, 2010
Last verified: July 2010
History of Changes
  Purpose

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 Intervention
Chronic Obstructive Pulmonary Disease
 Device: Electrostimulation
Device: Sham stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Effect of Electromyostimulation in Severe Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • Fiber-type distribution [ Time Frame: 6 to 8 weeks ] [ Designated as safety issue: No ]
    Typology was evaluated by immunohistochemistry


Secondary Outcome Measures:
  • Change in the strength of the quadriceps over the 6-week electrostimulation program [ Time Frame: 6 to 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: July 2006
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Electrostimulation
Neuromuscular electrical stimulation
 Device: Electrostimulation
Electrostimulation: 35 Hz, 0.4 ms, 1 h; 5 times/week
Other Name: NMES
Sham Comparator: Sham stimulation
Sham stimulation
 Device: Sham stimulation
Sham stimulation: 1 h; 5 times/week
Other Name: Sham

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.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01167283

Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Centre Hospitalier Régional Universitaire Montpellier
Investigators
Principal Investigator: Olivier OJ Jonquet, PU-PH Institut National de la Santé Et de la Recherche Médicale, France
  More Information

No publications provided

Responsible Party: Prefaut/PU-PH, AEROBIE
ClinicalTrials.gov Identifier: NCT01167283     History of Changes
Other Study ID Numbers: APARD
Study First Received: July 13, 2010
Last Updated: August 5, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
COPD

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013