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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ES | Active Comparator | Electrostimulation |
|
| Sham ES | Placebo Comparator | Sham stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrostimulation | Device | 50Hz; 0.4 ms; 30 min; 5 times / week |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the strength of the quadriceps over the 6-week electrostimulation program. | 6 to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilation at iso-time during an endurance shuttle walkMuscle | 6 to 8 weeks | |
| hypertrophying/atrophying pathways | 6 to 8 weeks | |
| Muscle aerobic capacity: fibre-typing, oxydative enzymes, muscle capillarization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| François Maltais, MD | Laval University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Laval | Québec | Quebec | G1V4G5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22116795 | Derived | Vivodtzev I, Debigare R, Gagnon P, Mainguy V, Saey D, Dube A, Pare ME, Belanger M, Maltais F. Functional and muscular effects of neuromuscular electrical stimulation in patients with severe COPD: a randomized clinical trial. Chest. 2012 Mar;141(3):716-725. doi: 10.1378/chest.11-0839. Epub 2011 Nov 23. |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Sham stimulation |
| Device |
30 min; 5 times / week |
|
| 6 to 8 weeks |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |