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Electrostimulation, Skeletal Muscle Function, and Exercise Capacity in Chronic Obstructive Pulmonary Disease (COPD) (ESTIM)

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. Identifier: NCT00874965
Recruitment Status : Completed
First Posted : April 3, 2009
Last Update Posted : October 10, 2012
Information provided by (Responsible Party):
Marthe Bélanger, Laval University

Brief Summary:

This study was designed to test the following hypothesis:

The benefit of electrostimulation training will be greater than sham stimulation training in term of muscle strength and mass (muscle hypertrophy), exercise tolerance, reduction of ventilation during exercise and quality of life in COPD patients

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

Detailed Description:

Background: Because it has little impact on ventilatory requirements and dyspnea, muscle electrostimulation appears as a promising alternative to general physical reconditioning in advanced COPD and its feasibility has been confirmed in this population. However, the physiological mechanisms underlying the proposed benefits of electrostimulation training have not been explored.

Objective: To evaluate in COPD patients the physiological mechanisms of changes in exercise tolerance after electrostimulation training.

Method: We propose to conduct a controlled, randomized and double blind clinical trial comparing the efficacy of muscle electrostimulation training of the lower limbs to sham training in 24 patients with COPD. Patients are included in either 6 weeks of electrostimulation training (active treatment group) or 6 weeks of sham electrostimulation. Before and after training, patients perform endurance shuttle walking test, muscle function testing, muscle biopsy, blood sampling and health-related quality of life questionnaire.

Planning analysis: The main outcome will be change in the strength of the quadriceps over the 6-week electrostimulation program. The other end-points will be mid-thigh and calf muscle cross-sectional area, lower limb muscle endurance, ventilation, dyspnea, leg fatigue, operational lung volumes at iso-time and walking time during an endurance shuttle walk, muscle hypertrophying/atrophying pathways and muscle aerobic capacity. For each group, pre- and post-training comparisons will be made using a repeated measures design. The magnitude of the pre- and post-training changes will also compared between both groups with a two-way ANOVA (group, training effect) with repeated measures on the second factor (training effect). A p value < 0.05 will be considered statistically significant.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Study of the Benefits of Lower Limb Electrostimulation Training on Muscular Parameters and Minute Ventilation During Exercise in Severe and Deconditioned COPD Patients.
Study Start Date : December 2006
Actual Primary Completion Date : May 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: ES
Device: Electrostimulation
50Hz; 0.4 ms; 30 min; 5 times / week

Placebo Comparator: Sham ES
Sham stimulation
Device: Sham stimulation
30 min; 5 times / week

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

Secondary Outcome Measures :
  1. Ventilation at iso-time during an endurance shuttle walkMuscle [ Time Frame: 6 to 8 weeks ]
  2. hypertrophying/atrophying pathways [ Time Frame: 6 to 8 weeks ]
  3. Muscle aerobic capacity: fibre-typing, oxydative enzymes, muscle capillarization [ Time Frame: 6 to 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • COPD
  • FEV1 < 60% predicted value and FEV1/ FVC < 70%
  • 6-minute walking distance < 400 m

Exclusion Criteria:

  • Patients suffering from cardiovascular, neurological, skeletal muscle, or any other condition that could alter their capacity to perform the exercise test
  • Patients taking systemic corticosteroids on a daily basis (patients having received systemic steroids for the treatment of up to two exacerbations in the preceding year and those on inhaled steroids will be allowed)
  • Patients with room air PaO2 < 60 mm Hg will be excluded.

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 identifier (NCT number): NCT00874965

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Canada, Quebec
Hôpital Laval
Quebec city, Quebec, Canada, G1V4G5
Sponsors and Collaborators
Laval University
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Principal Investigator: François Maltais, MD Laval University

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Marthe Bélanger, Professionnel de recherche, Laval University Identifier: NCT00874965     History of Changes
Other Study ID Numbers: CER20105
First Posted: April 3, 2009    Key Record Dates
Last Update Posted: October 10, 2012
Last Verified: October 2012
Keywords provided by Marthe Bélanger, Laval University:
Chronic Obstructive Pulmonary Disease (COPD)
Muscle function
Exercise ventilation
Anabolism/catabolism pathway
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases