Exercise Intolerance in Obstructive Sleep Apnea Syndrome Patients

NCT00837018 | Completed

• 2 other identifiers: 0520DGS 2005/0312
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

OSAS; exercise; metabolic; cardio-vascular

Outcome Measures

Primary Outcomes (1)

• Comparison of maximal oxygen consumption : OSAS patient versus control subjects.

  when the last patient realised the last visit

Secondary Outcomes (1)

• To compare physical exercise program to continuous positive airway pressure after 12 weeks of treatment in OSAS patients.

  when the last patient realised the last visit

Study Arms (1)

Physical exercise program

EXPERIMENTAL

45 min, 3 times a week

Other: physical exercise program

Interventions

physical exercise program OTHER

45 min, 3times a week

Physical exercise program

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• AGIR à Dom: collaborator

Study Sites (1)

CHU, medecine du sport

Grenoble, 38000, France

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Behavior

Study Officials

• Bernard Wuyam, doctor

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2009
• First Posted: February 4, 2009
• Study Start: June 1, 2005
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2012
• Last Updated: March 5, 2013

Record last verified: 2013-03

Locations

FR (1)