ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01167283
Recruitment Status : Completed
First Posted : July 22, 2010
Last Update Posted : August 6, 2010
Sponsor:
Collaborator:
Centre Hospitalier Régional Universitaire Montpellier
Information provided by:
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.


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Device: Electrostimulation Device: Sham stimulation Not Applicable

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  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Fiber-type distribution [ Time Frame: 6 to 8 weeks ]
    Typology was evaluated by immunohistochemistry


Secondary Outcome Measures :
  1. Change in the strength of the quadriceps over the 6-week electrostimulation program [ Time Frame: 6 to 8 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Prefaut/PU-PH, AEROBIE
ClinicalTrials.gov Identifier: NCT01167283     History of Changes
Other Study ID Numbers: APARD
First Posted: July 22, 2010    Key Record Dates
Last Update Posted: August 6, 2010
Last Verified: July 2010

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

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