Effect of Exercise Training on Obstructive Sleep Apnea Syndrome Severity

Study Overview
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Brief Summary
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Sleep apnoea affects more than 20% of people over 65 years and is largely underdiagnosed. It does multiply tenfold the occurrence of vascular events, particularly stroke. While Continuous Positive Airway Pressure (CPAP) is currently the Gold standard treatment to prevent cerebrovascular and cardiovascular events, with a major clinical benefit, long term adherence to CPAP is a significant problem and search for alternative treatment is essential. The investigators hypothesize that long-term exercise training would allow to reduce significantly sleep apnoea syndrome severity. Thus, in this study, the investigators will compare evolution of Apnoea Hypopnea Index (AHI) in an exercise trained group performed through in a national based non-profit organization (Fédération Française d'éducation Physique et de Gymnastique Volontaire (FFEPGV)) using a medical established program (NeuroGyV) during nine months against a control group receiving only standard dietetic and physical activity counseling.

Official Title
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Effect of Exercise Training on Obstructive Sleep Apnea Syndrome Severity

Conditions
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Sleep Apnea Syndromes, Sleep Apnea, Obstructives

Intervention / Treatment
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* Other: Training
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients affiliated or entitled to a social security system Patients with AHI from 15 to 30 per hour Signature of consent Exclusion Criteria: Patients being already treated for sleep apnea or clinical status (cardiovascular comorbidities) justifying an immediate initiation of CPAP Daytime sleepiness (ESS score > 10) Known respiratory or heart disease (or discovering during stress test) contraindicated exercise training Patients with Parkinson's disease

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training<br>In this group, patients will perform 3 sessions of one hour per week of the NeuroGyV training program. It is a physical activity program with one session of Nordic walking, one session of aquagym and one session of gymnastic. Program lasts 9 months. | Other: Training<br> <br> * Other names: NeuroGyV program;|
| Other: Control<br>In this group, patients will receive only diets and physical activity counselling | Other: Control<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Final polysomnography | Percentage of patients with AHI < 15/hour through polysomnography assessment after nine months of follow-up in the training and the control groups | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First intermediate polysomnography | Percentage of patients with AHI<15/hour through polysomnography assessment after three months of follow-up in the training and the control groups. | 3 months | 
| Second intermediate polysomnography | Percentage of patients with AHI<15/hour through polysomnography assessment after six months of follow-up in the training and the control groups. | 6 months | 
| High frequency | Correlation between change in AHI and change in high frequency (HF) of spectral analysis of heart rate variability (parasympathetic index) at 9 months of follow-up in the 2 groups | 9 months | 
| Maximal aerobic capacity (VO2Max) | Correlation between the change in VO2max during stress test, walking distance during 6 minutes and AHI in the two groups | 9 months | 
| Population Physical Activity questionnaire (POPAQ) | Correlation between the change in daily physical activity energy expenditure (estimated by the POPAQ questionnaire) and AHI in the two groups | 9 months | 
| Daily physical activity energy expenditure | Correlation between the daily physical activity energy expenditure (estimated directly by an actimetry sensor for 7 days) and AHI in the two groups | 9 months | 
| Epworth sleepiness Scale | Comparison of the variation of Epworth Sleepiness Scale (ESS) after 9 months follow-up for the two groups | 9 months | 
| Pittsburgh questionnaire | Comparison of the variation of Pittsburgh questionnaire after 9 months follow-up for the two groups | 9 months | 
| Berlin questionnaire | Comparison of the variation of Berlin questionnaire after 9 months follow-up for the two groups | 9 months | 
| Blood pressure - Baroreflex | Measure of autonomic function (parasympathetic activity) - quantified via changes in blood pressure | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep Apnea Syndromes, Sleep Apnea, Obstructives, Training