Exercise and Venous Compression on Upper Airway Resistance in Obese Teenagers With OSA

Study Overview
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Brief Summary
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The purpose of this study is to assess the effects of physical exercise, associated or not with venous compression of the leg, on obstructive sleep apnea (OSA) severity and upper airway resistance in obese teenagers. Half of the participants will undergo physical exercise and compression socks program, and the other half of subjects will undergo physical exercise program without compression socks.

Detailed Description
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Obesity is an important factor of OSA development in children and teenagers, and physical activity is a relevant alternative to promote OSA decrease with ou without weight loss. Physical activity, beyond the improvement of body composition and exercise cardiorespiratory capacity, restricts fluid retaining in the lower limb of the leg by the activation of musculovenous pump. Fluid retaining is involved in OSA severity because of nocturnal fluid shift from legs to rostral zone which promotes pharyngeal oedema development and upper airway collapsibility. It has been previously shown that venous compression leads to beneficial fluid regulation in OSA subjects and appears as an efficient tool in OSA management. To the investigators knowledge no study assess the impact of the cumulative effect of physical and venous compression program on upper airway resistances in obese teenager with OSA.

Official Title
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Effects of Exercise and Venous Compression on Upper Airway Resistance in Obese Teenagers With Obstructive Sleep Apnea Syndrome

Conditions
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Pediatric Obesity, Sleep Apnea, Obstructive

Intervention / Treatment
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* Other: Interventional group
* Other: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Obese adolescents (BMI > 97th percentile), patients aged from 12 to 17 years old, (born between 07/01/2003 and 09/01/1197), enrolled in a pediatric obesity center with diet and physical activity programs and psychological management, without observed tonsils hypertrophy (Mallampati and Friedman scores), without contraindication for bioimpedance analysis, acoustic method and stain gauge plethysmography, with physical activity certificate issued by a cardiologist covered by the national insurance scheme of his/her legal representative, having signed, as well as his(her) legal representative, the informed consent of participation. Exclusion Criteria: Non obese adolescents (BMI < 97th percentile) patients aged under 12 or over 17 years old, not enrolled in a pediatric obesity center with diet and physical activity programs and psychological management, with observed tonsils hypertrophy (Mallampati and Friedman scores), with contraindication for bioimpedance analysis, acoustic method and stain gauge plethysmography, without physical activity certificate issued by a cardiologist uncovered by the national insurance scheme of his/her legal representative, not having signed, as well as his(her) legal representative, the informed consent of participation.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 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: Interventional group<br>Physical activity program coupled with compression socks wearing during 3 months. | Other: Interventional group<br>* Venous compression leads to beneficial fluid regulation in OSA participants and appears as an efficient tool in OSA management. To the investigators knowledge no study assess the impact of the cumulative effect of physical and venous compression program on upper airway resistances in obese teenager with OSA.<br>|
| Active Comparator: control group<br>Physical activity program without compression socks during 3 months. | Other: Control group<br>* Standard obesity care with physical activity program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Obstructive sleep apnea severity at 3 months. | Obstructive Sleep Apnea change will be assessed with polysomnography system at baseline and after three months | This study includes 2 assessments : baseline (T0) and 3 months (T3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper airway resistances | upper airway resistance will be assessed by acoustic method | This study includes 2 assessments : baseline (T0) and 3 months (T3) | 
| Fluid shift | fluid shift will be assessed by bioimpedance analysis | This study includes 2 assessments : baseline (T0) and 3 months (T3) | 
| Calf and neck circumferences | Calf and neck circumferences will be assessed with nonelastic tape | This study includes 2 assessments : baseline (T0) and 3 months (T3) | 
| Calf and neck circumferences | Calf and neck circumferences will be assessed by plethysmography | This study includes 2 assessments : baseline (T0) and 3 months (T3) | 
| Anthropometric parameters | weight, height, waist and hip circumferences (body weight scale, standing stadiometer and non-elastic tape) | This study includes 2 assessments : baseline (T0) and 3 months (T3) | 
| Body composition | fat mass, fat free mass ( by bioimpedance analysis) | This study includes 2 assessments : baseline (T0) and 3 months (T3) | 
| Pulmonary function during exercise | Incremental maximal exercise in cycling ergometer with respiratory gas assessment (metamax) | This study includes 2 assessments : baseline (T0) and 3 months (T3) | 
| Metabolic responses | Glucose, LDL-Cholesterol, HDL-Cholesterol, Total Cholesterol, Triglycerides (ELISA and RIA technics) | This study includes 2 assessments : baseline (T0) and 3 months (T3) | 
| Hormonal responses | Insulin, leptin, adiponectin, catecholamines (ELISA and RIA technics) | This study includes 2 assessments : baseline (T0) and 3 months (T3) | 
| Inflammatory responses | C-reactive protein (ELISA and RIA technics) | This study includes 2 assessments : baseline (T0) and 3 months (T3) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric obesity, obstructive sleep apnea, physical exercise, compression socks, rostral fluid shift