Exercise Intolerance in Obstructive Sleep Apnea Syndrome Patients

NCT ID: NCT00837018

Last Updated: 2013-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2012-05-31

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 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.

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

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Blinding Strategy: SINGLE

Study Groups

Physical exercise program

45 min, 3 times a week

Group Type: EXPERIMENTAL

physical exercise program

Intervention Type: OTHER

45 min, 3times a week

Interventions

physical exercise program

45 min, 3times a week

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AGIR à Dom

OTHER

Sponsor Role: collaborator

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bernard Wuyam, doctor

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

CHU, medecine du sport

Grenoble, , France

Countries

France

Other Identifiers

DGS 2005/0312

Identifier Type: REGISTRY

Identifier Source: secondary_id

0520

Identifier Type: -

Identifier Source: org_study_id