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Exercise Intolerance in Obstructive Sleep Apnea Syndrome Patients (EXAOS)

This study has been completed.
Sponsor:
Collaborator:
AGIR à Dom
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00837018
First received: February 3, 2009
Last updated: March 4, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention
Obstructive Sleep Apnea
 Other: physical exercise program

Study Type: Interventional
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: June 2005
Study Completion Date: May 2012
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Physical exercise program
45 min, 3 times a week
 Other: physical exercise program
45 min, 3times a week

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

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00837018

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

No publications provided

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT00837018     History of Changes
Other Study ID Numbers: 0520, DGS 2005/0312
Study First Received: February 3, 2009
Last Updated: March 4, 2013
Health Authority: France: Direction Générale de la Santé

Keywords provided by University Hospital, Grenoble:
OSAS
exercise
metabolic
cardio-vascular

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

ClinicalTrials.gov processed this record on May 22, 2013