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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Grenoble, France, 38000
- CHU, medecine du sport
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Physical exercise program
45 min, 3 times a week
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45 min, 3times a week
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Comparison of maximal oxygen consumption : OSAS patient versus control subjects.
Délai: when the last patient realised the last visit
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when the last patient realised the last visit
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
To compare physical exercise program to continuous positive airway pressure after 12 weeks of treatment in OSAS patients.
Délai: when the last patient realised the last visit
|
when the last patient realised the last visit
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Bernard Wuyam, doctor, University Hospital, Grenoble
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 0520
- DGS 2005/0312 (Identificateur de registre: DGS)
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