Exercise Intolerance in Obstructive Sleep Apnea Syndrome Patients (EXAOS)
|ClinicalTrials.gov Identifier: NCT00837018|
Recruitment Status : Completed
First Posted : February 4, 2009
Last Update Posted : March 5, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea||Other: physical exercise program||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Factorial Assignment|
|Official Title:||Exercise Intolerance in Obstructive Sleep Apnea Syndrome Patients: Cardiovascular and Metabolic Characterisation During Exercise. Treatments Effect.|
|Study Start Date :||June 2005|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||May 2012|
Experimental: Physical exercise program
45 min, 3 times a week
Other: physical exercise program
45 min, 3times a week
- Comparison of maximal oxygen consumption : OSAS patient versus control subjects. [ Time Frame: when the last patient realised the last visit ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00837018
|CHU, medecine du sport|
|Grenoble, France, 38000|
|Principal Investigator:||Bernard Wuyam, doctor||University Hospital, Grenoble|