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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Grenoble, Frankrike, 38000
- CHU, medecine du sport
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Tilldelning: Randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Physical exercise program
45 min, 3 times a week
|
45 min, 3times a week
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Comparison of maximal oxygen consumption : OSAS patient versus control subjects.
Tidsram: when the last patient realised the last visit
|
when the last patient realised the last visit
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
To compare physical exercise program to continuous positive airway pressure after 12 weeks of treatment in OSAS patients.
Tidsram: when the last patient realised the last visit
|
when the last patient realised the last visit
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Bernard Wuyam, doctor, University Hospital, Grenoble
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 0520
- DGS 2005/0312 (Registeridentifierare: DGS)
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