Effect of Neuromuscular Electrical Stimulation Versus Cycle Ergometer Training in a Pulmonary Rehabilitation Program

Study Overview
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Brief Summary
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The aim of this study is to evaluate the effectiveness of quadriceps strengthening with neuromuscular electrical stimulation versus cycle ergometer as part of pulmonary rehabilitation program , in patients with severe or very severe COPD , according to GOLD with BODE index ≥ 5 .

Detailed Description
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It's a prospective ,multicentre,randomised, single-blind study which compare the effectiveness of quadriceps strengthening with neuromuscular electrical stimulation versus cycle ergometer training as part of pulmonary rehabilitation program. The program lasts from 3 to 4 weeks. 102 patients will included, diagnosed with COPD stages GOLD III and IV, and BODE index ≥ 5. The commun program: training protocol performed on treadmill,quadriceps resistance training,patient therapeutic education,collective gymnastics,relaxation, session psychological care, smoking cessation program and nutritional management if necessary. The primary criterion is the one minute sit to stand test.

Official Title
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Effect of Neuromuscular Electrical Stimulation Versus Cycle Ergometer Training in a Pulmonary Rehabilitation Program

Conditions
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COPD

Intervention / Treatment
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* Device: neuromuscular electrical stimulation
* Device: cycle ergometer training
* Other: Conventional pulmonary rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with COPD stage 3 or 4, with BODE index ≥ 5 Hospitalized in the pulmonary rehabilitation unit in the hospital of Morlaix or in the center Les Acacias of briançon, with a 3 at 4 weeks pulmonary rehabilitation course; Exclusion Criteria: FEV ≥ 50% Pneumonectomy, Lobectomy less than 6 months Contraindications to muscle electrostimulation quadriceps Absence of written consent Inability to follow the respiratory rehabilitation program in its entirety People equipped with electronic devices such as pacemakers and intracardiac defibrillators Skin lesions and infectious foci on the electrode placement area.

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: neuromuscular electrical stimulation<br>conventional pulmonary rehabilitation including exercise training on treadmill and neuromuscular electrical stimulation with a medical device for quadriceps muscle strengthening | Device: neuromuscular electrical stimulation<br>* quadriceps strenghthening with neuromuscular electrical stimulation (medical device)<br>Other: Conventional pulmonary rehabilitation<br>* excercise training on treadmill<br>|
| Experimental: cycle ergometer training<br>conventional pulmonary rehabilitation including exercise training on treadmill and quadriceps strenghthening on cycle-ergometer | Device: cycle ergometer training<br>* quadriceps strenghthening with cycle ergometer training<br>Other: Conventional pulmonary rehabilitation<br>* excercise training on treadmill<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional capacity of the lower limb muscles | Measure of the functional capacity of the lower limb muscles with the 1 minute Sit To Stand Test  | 21 - 4 days / +7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal isometric voluntary quadriceps strength assessment | Quadriceps strength assessment with handheld dynamometer | 21 - 4 days / +7 days | 
| isometric voluntary quadriceps endurance assessment | Measure of isometric voluntary quadriceps endurance assessment with handheld dynamometer | 21 - 4 days / +7 days | 
| assessment of exercise capacity | Six minute walking test for assessing exercise capacity | 21 - 4 days / +7 days | 
| Quality of Life Assessment | COPD assessment test for assessing quality of life | 21 - 4 days / +7 days | 
| Dyspnea Assessment with Borg scale | Measure of dyspnea with Borg scale at the end of the six minute walking test | 21 - 4 days / +7 days | 
| Dyspnea Assessment with MRC Scale | Measure of dyspnea with Medical Research Council Dyspnea Scale | 21 - 4 days / +7 days | 
| Dyspnea Assessment with Dyspnea 12 questionnary | Measure of dyspnea with Dyspnea 12 questionnary | 21 - 4 days / +7 days | 
| Inspiratory capacity (in litres) by spirometry | Measure of inspiratory capacity (in litres) by spirometry | 21 - 4 days / +7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD pulmonary rehabilitation, neuromuscular electrical stimulation, sit to stand test COPD, quadriceps strengthening