Exercise Intolerance in Obstructive Sleep Apnea Syndrome Patients (EXAOS)
Exercise Intolerance in Obstructive Sleep Apnea Syndrome Patients: Cardiovascular and Metabolic Characterisation During Exercise. Treatments Effect.
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Grenoble, Frankrijk, 38000
- CHU, medecine du sport
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Toewijzing: Gerandomiseerd
- Interventioneel model: Faculteitstoewijzing
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Physical exercise program
45 min, 3 times a week
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45 min, 3times a week
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Comparison of maximal oxygen consumption : OSAS patient versus control subjects.
Tijdsspanne: when the last patient realised the last visit
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when the last patient realised the last visit
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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To compare physical exercise program to continuous positive airway pressure after 12 weeks of treatment in OSAS patients.
Tijdsspanne: when the last patient realised the last visit
|
when the last patient realised the last visit
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Bernard Wuyam, doctor, University Hospital, Grenoble
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 0520
- DGS 2005/0312 (Register-ID: DGS)
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