NCT01155271

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: AGIR à Dom · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Obesity
• Sleep Apnea

Interventions

Type	Name	Description
OTHER	Rehabilitation	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

Timeline

• Start date: 2010-07-01
• Primary completion: 2014-12-01
• Completion: 2018-12-01
• First posted: 2010-07-01
• Last updated: 2018-10-02

Locations

2 sites across 2 countries: Canada, France