Ignite Creation Date:
2024-05-05 @ 9:11 PM
Last Modification Date:
2024-10-26 @ 10:01 AM
Study NCT ID:
NCT00837018
Status:
COMPLETED
Last Update Posted:
2013-03-05
First Post:
2009-02-03
Brief Title:
Exercise Intolerance in Obstructive Sleep Apnea Syndrome Patients
Sponsor:
University Hospital Grenoble
Organization:
University Hospital Grenoble
Study Overview
Official Title:
Exercise Intolerance in Obstructive Sleep Apnea Syndrome Patients Cardiovascular and Metabolic Characterisation During Exercise Treatments Effect
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EXAOS
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 regularIn 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
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 regularIn 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DGS 20050312 | REGISTRY | DGS | None |