Exercise Intolerance in Obstructive Sleep Apnea Syndrome Patients (EXAOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00837018
Recruitment Status : Completed
First Posted : February 4, 2009
Last Update Posted : March 5, 2013
AGIR à Dom
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:

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

Detailed Description:

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
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Physical exercise program
45 min, 3 times a week
Other: physical exercise program
45 min, 3times a week

Primary Outcome Measures :
  1. Comparison of maximal oxygen consumption : OSAS patient versus control subjects. [ Time Frame: when the last patient realised the last visit ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Ages Eligible for Study : 18 Years and above
  • Genders Eligible for Study: Both
  • Non obese : body mass index (BMI < 30 kg/m2)
  • Sedentary subjects : less physical activity than 30 minutes 3 time a week
  • and VOORIPS physical activity level questionnaire score < 9.

Obstructive sleep apnea syndrome (OSAS) patients :

  • Recently diagnosed (< 3 months)
  • AHI > 30 / hour (polysomnographic monitoring measurement)

Exclusion Criteria:

  • Excessive daytime sleepiness (Epworth score > 12)
  • Cardiovascular pathology (except controlled hypertension)
  • Pathology interacting with physical activity
  • Diabetes (known or treated)
  • Other participation to a clinical trial at the same

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00837018

CHU, medecine du sport
Grenoble, France, 38000
Sponsors and Collaborators
University Hospital, Grenoble
AGIR à Dom
Principal Investigator: Bernard Wuyam, doctor University Hospital, Grenoble

Responsible Party: University Hospital, Grenoble Identifier: NCT00837018     History of Changes
Other Study ID Numbers: 0520
DGS 2005/0312 ( Registry Identifier: DGS )
First Posted: February 4, 2009    Key Record Dates
Last Update Posted: March 5, 2013
Last Verified: March 2013

Keywords provided by University Hospital, Grenoble:

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases