- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01167283
Effect of Electrostimulation in Chronic Obstructive Pulmonary Disease (COPD) (ExaEMS2005)
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
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
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
Electrostimulation: 35 Hz, 0.4 ms, 1 h; 5 times/week
Other Names:
|
Sham Comparator: Sham stimulation
|
Sham stimulation: 1 h; 5 times/week
Other Names:
|
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
Collaborators
Investigators
- Principal Investigator: Olivier OJ Jonquet, PU-PH, Institut National de la Santé Et de la Recherche Médicale, France
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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