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