Electrostimulation, Skeletal Muscle Function, and Exercise Capacity in Chronic Obstructive Pulmonary Disease (COPD) (ESTIM)
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
Chronic Obstructive Pulmonary Disease (COPD)
Device: Sham stimulation
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.|
- Change in the strength of the quadriceps over the 6-week electrostimulation program. [ Time Frame: 6 to 8 weeks ] [ Designated as safety issue: No ]
- Ventilation at iso-time during an endurance shuttle walkMuscle [ Time Frame: 6 to 8 weeks ] [ Designated as safety issue: No ]
- hypertrophying/atrophying pathways [ Time Frame: 6 to 8 weeks ] [ Designated as safety issue: No ]
- Muscle aerobic capacity: fibre-typing, oxydative enzymes, muscle capillarization [ Time Frame: 6 to 8 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||December 2006|
|Study Completion Date:||June 2009|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
Active Comparator: ES
50Hz; 0.4 ms; 30 min; 5 times / week
Placebo Comparator: Sham ES
Device: Sham stimulation
30 min; 5 times / week
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.