Study of Neuromuscular Electrical Stimulation to Increase Spontaneous Physical Activity in Obesity Patient

Study Overview
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Brief Summary
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The study was designed to test the following hypotheses: Main Objective: To compare the level of spontaneous physical activity at 3 months after re-entrainment by multi-site electrical stimulation (m-ES), measured by actigraphy over 7 days, compared to conventional care (lifestyle and dietary advice and placebo (simulated) electrostimulation) (control arm). Secondary Objectives: To compare the metabolic, inflammatory, cardiovascular and functional parameters, physical activity, quality of life and quality of sleep, at 3 months and at 2 years in the two groups. Design: We will conduct a multicenter controlled study vs. reference care with randomization into two parallel groups and double-blind (placebo electrostimulation). Patients will have the ES material available at home and will be supervised by monthly visits over 3 months and by telephone follow-up for two years. The study size calculation is based on physical activity, the percentage of lean body mass and arterial stiffness measured in the OBEX study. This project will determine whether the training strategy is effective for increasing physical activity and/or in inducing significant metabolic and cardiovascular effects in these patients after 2 years. In addition, it provides a solid base of investigation for the study of the interactions between muscle contraction and cardio-metabolic health with greater precision.

Detailed Description
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Obesity and sleep apnea syndrome lead to metabolic troubles and increasing cardiovascular risk. Furthermore, both diseases are associated with reduced exercise tolerance. For many patients with morbid obesity, the implementation of physical activity programs remains difficult for several reasons including the level of disability and psychosocial causes (the scrutiny of others, depression and poorly adapted equipment). Main hypothesis: Neuromuscular electrostimulation is a way to increase spontaneous physical activity (PA) in treated apneic obese patients with low spontaneous physical activity

Official Title
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Study of Multi-site Neuromuscular Electrical Stimulation to Increase Spontaneous Physical Activity in Obesity Patient Carrying Severe Inactive: Randomized Controlled Trial vs Placebo

Conditions
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Obesity, Number of Steps Per Day < 7000

Intervention / Treatment
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* Other: Rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Obese patients with BMI > 35 kg/m² CPAP treatment and > 4h observance per night to the patient with SAS Patients who give written consent Patients who subscribed social insurance Exclusion Criteria: Cardiovascular or respiratory failure discovered at the moment of the inclusion in the study Contraindication to exercise Pregnant or breast-feed woman Patients under guardianship Imprisoned patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Kneehab<br>5 sessions per week | Other: Rehabilitation<br>* 12 weeks : 5 sessions per week (1 supervised session at home every month) 92 weeks : spontaneous training (supervised by phone every month)<br>|
| Placebo Comparator: Placebo<br>5 sessions per week | Other: Rehabilitation<br>* 12 weeks : 5 sessions per week (1 supervised session at home every month) 92 weeks : spontaneous training (supervised by phone every month)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physical activity | Number of steps per day Number of METs per day | After a period of monthly supervised training program by neuromuscular electrical stimulation at home (12th wk) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in body composition | Fat mass and fat-mass index as assessed by impedancemetry measurements | After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and during a period of spontaneous training (48 th, 72 th, 96 th week) | 
| Change in arterial stiffness | Pulse wave velocity | After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and during a period of spontaneous training (48 th, 72 th, 96 th week) | 
| Change in endothelial function | Peripheral arterial tone (RH-PAT) | After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and after a period of spontaneous training (92th week ) | 
| Change in plasmatic biomarkers | Oxidative stress and inflammatory blood parameters | After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and after a period of spontaneous training (92th week ) | 
| Change in quality of life | SF-12 questionnaire | After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and after a period of spontaneous training (92th week ) | 
| Number of cardiovascular events per year | Questionnaire sent to the patient by mail | Every year from the 1st to the 2th year | 
| Change in other parameters of physical activity | Energy expenditure (total and during daily activities) | After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and during a period of spontaneous training (48 th, 72 th, 96 th week) | 
| Change in sleep quality | Lying and sleep duration | After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and during a period of spontaneous training (48 th, 72 th, 96 th week) |