Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
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.
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
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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