Quadricipital Electrical Stimulation in COPD Patients Rehabilitation

Study Overview
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Brief Summary
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Quadricipital electrical stimulation added to respiratory rehabilitation in COPD patients. Quadricipital electrical stimulation (ES) in chronic obstructive pulmonary disease (COPD) patients has been demonstrated to improve both dyspnea and physical status. The aim of our study is to demonstrate that ES added to respiratory rehabilitation program induces a greater improvement on exercise tolerance in such patients. Design : 160 patients with severe COPD will be randomly assigned to 2 groups : either rehabilitation program (group 1), either ES and rehabilitation program (group 2). In both groups, rehabilitation program comprises endurance training, 18 - 24 sessions (6 - 8 weeks), health education, global muscular strengthening. In group 2, bilateral quadricipital electrical stimulation 30 min sessions is added 5 days / week. Subjects : COPD patients with FEV1 < 60% pred, FEV1/VC < 70%, and TLC > 80%, with dyspnea, in stable conditions, and 18 > BMI < 35 kg/m² . Intervention : 6 min walking distance, incremental exercise test data (aerobic capacity, work rate, ventilatory threshold), physical activity with activity monitor, health related quality of life will be determined before and after training. Abbreviations : FEV1 = forced expiratory volume in 1 sec; VC = vital capacity; TLC = total lung capacity; BMI = body mass index.

Official Title
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Quadricipital Electrical Stimulation in COPD Patients Rehabilitation

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Device: group 2 : quadricipital electrical stimulation
* Other: pulmonary rehabilitation
* Device: muscular electrical stimulation
* Other: pulmonary rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects : COPD patients with FEV1 < 60% pred, FEV1/VC < 70%, and TLC > 80%, with dyspnea, in stable conditions, and 18 > BMI < 35 kg/m² Exclusion Criteria: BMI 18 < or > 35 kg/m² Pregnant women peripheral neuropathy cardio respiratory incremental test contra-indication evolutive cancer cardiac or cerebral pace maker, implanted cardio defibrillator no informed consent given

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 2 : quadricipital electrical stimulation<br>stimulation in addition to rehabilitation (30 min bilateral quadricipital electrical stimulation pd, 5 days per week, 8 weeks) | Device: group 2 : quadricipital electrical stimulation<br>* bilateral quadricipital electrical stimulation 5 sessions a week, (6 - 8 weeks)<br>Device: muscular electrical stimulation<br>* Bilateral quadricipital electrical stimulation 30 min, 5 times per week, 8 weeks,in addition to pulmonary rehabilitation<br>* Other names: Mi-Theta-Pro device (Compex medical SA ; CH - 1024 Ecublens); reference 498000 ; serial number WB100000.;|
| Active Comparator: Group 1 : Pulmonary rehabilitation<br>Pulmonary rehabilitation 3 to 5 times per week, 8 weeks | Other: pulmonary rehabilitation<br>* exercise training, 3 to 5 times per week, 8 weeks<br>Other: pulmonary rehabilitation<br>* exercise training, 45 min, 3 to 5 times per week, 8 weeks<br>* Other names: exercise training;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 minute walking distance |  | From 6 to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incremental cardio pulmonary exercise test | Aerobic capacity, maximal achieved work rate, ventilatory threshold | From 6 to 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, electrical stimulation, Rehabilitation, exercise test