Electrostimulation, Skeletal Muscle Function, and Exercise Capacity in Chronic Obstructive Pulmonary Disease (COPD) (ESTIM)
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|ClinicalTrials.gov Identifier: NCT00874965|
Recruitment Status : Completed
First Posted : April 3, 2009
Last Update Posted : October 10, 2012
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|
|Chronic Obstructive Pulmonary Disease (COPD)||Device: Electrostimulation Device: Sham stimulation|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Primary Completion Date :||May 2009|
|Study Completion Date :||June 2009|
Active Comparator: ES
50Hz; 0.4 ms; 30 min; 5 times / week
Placebo Comparator: Sham ES
Device: Sham stimulation
30 min; 5 times / week
- Change in the strength of the quadriceps over the 6-week electrostimulation program. [ Time Frame: 6 to 8 weeks ]
- Ventilation at iso-time during an endurance shuttle walkMuscle [ Time Frame: 6 to 8 weeks ]
- hypertrophying/atrophying pathways [ Time Frame: 6 to 8 weeks ]
- Muscle aerobic capacity: fibre-typing, oxydative enzymes, muscle capillarization [ Time Frame: 6 to 8 weeks ]
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): NCT00874965
|Quebec city, Quebec, Canada, G1V4G5|
|Principal Investigator:||François Maltais, MD||Laval University|