OBese Patients With Obstructive Sleep Apnea Syndrome(OSAS) and EXercise Training

Study Overview
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Brief Summary
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The study was designed to test the following hypotheses: In obese patients with OSAS, the benefit of the combination of exercise training + continuous positive airway pressure (CPAP) will be higher than CPAP alone in term of functional capacity, metabolic, inflammatory, cardiovascular and sleep parameters and quality of life. In obese patients with OSAS, the benefit of training using ventilatory assistance (NIV) during cycloergometer [cycloergometer with NIV] or respiratory muscles training (spirotiger) in addition to cycloergometer [cycloergometer + spirotiger] will be higher than cycloergometer training alone [cycloergometer] in term of functional and exercise capacities. Dyspnea during walking test and respiratory muscle strength at baseline could influence the response to combined exercise training such as [cycloergometer + NIV] or [cycloergometer + spirotiger]

Detailed Description
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Background: Obesity and sleep apnea syndrome lead to metabolic troubles and increasing cardiovascular risk. Furthermore, both diseases are associated with reduced exercise tolerance. We hypothesized that exercise training could be complementary to nocturnal ventilatory treatment in restoring metabolic disturbances, exercise tolerance and sleep parameters in obese patients with SAS. Objective: To evaluate the effect of training on exercise tolerance (walking distance and dyspnea during walk)(main objective), systemic inflammation, vascular endothelial function, insulin resistance, quality of sleep and quality of life in obese patients treated by CPAP for OSAS (secondary objectives) Methods: We proposed to conduct a controlled, randomized clinical trial comparing the efficacy of 3 different modalities of training in obese patients with SAS. After a 6-week control pre-inclusion period, patients are included in either [cycloergometer] vs. [cycloergometer with ventilatory assistance] vs. [cycloergometer + respiratory muscle exercises]. Before and after the control period, and both immediately and 9 month after training, patients perform walking test, maximal incremental test on cycloergometer, blood sampling and cardiovascular function, body composition, muscle function, quality of sleep and quality of life assessments as well as spontaneous physical activity measurement. During the 5 years following inclusion in the training program, the number of cardiovascular event is recorded every year. An interim analysis will be carried out when 30 will have completed the third evaluation session (after the training program). The Peto's method will be used to correct the p-values.

Official Title
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Comparison of 3 Exercise Training Modalities in Obese Patient With Sleep Apnea Syndrome Treated by Continue Positive Airway Pressure : a Randomized Controlled Study

Conditions
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Obesity, Sleep Apnea

Intervention / Treatment
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* Other: Rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: OSAS (AHI > 30 before CPAP treatment) > 4h/d CPAP treatment adherence Obese patients with 35 < BMI < 45 kg/m2 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ERGO<br>General endurance training on cycloergometer | Other: Rehabilitation<br>* 12 weeks : 3 sessions per week (2 supervised sessions and 1 session at home) 1 technical visit and 1 nursing visit every two months at home for the CPAP<br>|
| Active Comparator: ERGONIV/ ERGOSPIRO<br>General endurance training on cycloergometer using ventilatory assistance (ERGONIV) or additional respiratory muscle training (ERGOSPIRO) | Other: Rehabilitation<br>* 12 weeks : 3 sessions per week (2 supervised sessions and 1 session at home) 1 technical visit and 1 nursing visit every two months at home for the CPAP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in exercise tolerance during walking test | walking distance dyspnea score | After control period (6th wk) vs. after training period (18th wk) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Aerobic capacity | Maximal oxygen consumption | After control period (6th wk) vs. after training period (18th and 52th wks) | 
| Changes in cardiovascular and metabolic function | Pulse wave velocity, peripheral arterial tone, BP, inflammatory and metabolic plasmatic markers | After control period (6th wk) vs. after training period (18th and 52th wks) | 
| Changes in sleep parameters and Quality Of life | Nocturnal oxygen saturation, CPAP data, Epworth questionnaire, Short Form (36) Health Survey questionnaire | After control period (6th wk) vs. after training period (18th and 52th wks) | 
| Number of cardiovascular events per year | Questionnaire sent to the patient by mail | Every year from the 1st to the 5th year | 
| Changes in body composition | Fat mass and fat-mass index Fat-free mass and fat-free mass index assessed by impedancemetry measurements | After control period (6th wk) vs. after training period (18th and 52th wks) | 
| Change in physical activity and sleep duration | Number of hour per day of physical activity at 1, 2, 3 or 4 Metabolic Equivalents (METS); Number of steps per day; Sleep to lying position duration ratio | After control period (6th wk) vs. after training period (18th and 52th wks) | 
| Change in exercise tolerance during walking test | isotime dyspnea isotime oxygen saturation | After control period (6th wk) vs. after trainng (52th wk) | 
| Change in physiological variables during the control period | functional and exercise parameters cardiovascular parameters metabolic parameters sleep and quality of life parameters (Short Form (36) Health Survey) physical activity | Before (1st) vs. after control period (6th wk) | 
| Baseline characteristics | functional and exercise parameters cardiovascular parameters metabolic parameters sleep and quality of life parameters (Short Form (36) Health Survey) physical activity | Before control period (1st week) or after the control period (6th week) |