Exercise Intolerance in Obstructive Sleep Apnea Syndrome Patients (EXAOS)
The syndrome of obstructive sleep apnea (OSAS) is a public health problem that affects 2 to 4% of the general population. The patients with OSAS frequently complain of intolerance to exercise muscle fatigue and a significant even if they have not been fully characterized in the literature.
The anomalies in the exercise of patients with OSAS could be due to metabolic changes (insulin resistance and oxidative stress) and cardiovascular (impaired vascular reactivity).
Our goal is both to determine whether these anomalies exist in patients with OSAS not obese, consider their relationship with the alteration of exercise capacity, and their reversibility in conventional PPC or by using the effects of physical activity regular.In this study Objectives: To establish whether the metabolic and vascular abnormalities associated with OSAS are associated with decreased parameters of physical fitness in relation to witnesses matched for age, sex and body mass index. Determine the effects of a re-training exercise on these parameters compared to the reference treatment, continuous positive pressure.
Main objective: To compare the exercise capacity of OSAS patients compared with that of witnesses matched for age, sex and body mass index.
Secondary objectives: To compare the effect of conventional treatment by continuous positive pressure (CPP) on cardiovascular and metabolic abnormalities of OSAS, with a therapeutic modality most original, physical activity.
Methodology: Test physiopathological parallel group, controlled, randomized.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
|Official Title:||Exercise Intolerance in Obstructive Sleep Apnea Syndrome Patients: Cardiovascular and Metabolic Characterisation During Exercise. Treatments Effect.|
- Comparison of maximal oxygen consumption : OSAS patient versus control subjects. [ Time Frame: when the last patient realised the last visit ] [ Designated as safety issue: No ]
- To compare physical exercise program to continuous positive airway pressure after 12 weeks of treatment in OSAS patients. [ Time Frame: when the last patient realised the last visit ] [ Designated as safety issue: No ]
|Study Start Date:||June 2005|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Experimental: Physical exercise program
45 min, 3 times a week
Other: physical exercise program
45 min, 3times a week
Study type : Physiopathology trial Study design : Prospective randomized controled trial
Expected Total Enrollment : 45 patients + 15 control subjects
Tested treatment : Physical exercise program (45 minutes, 3 times a week) Reference treatment : continuous positive airway pressure Treatment duration : 12 weeks (3 months) Total study duration : 2 years
Please refer to this study by its ClinicalTrials.gov identifier: NCT00837018
|CHU, medecine du sport|
|Grenoble, France, 38000|
|Principal Investigator:||Bernard Wuyam, doctor||University Hospital, Grenoble|