Pediatric Obesity, Sleep Apnea, Obstructive
Conditions
Keywords
pediatric obesity, obstructive sleep apnea, physical exercise, compression socks, rostral fluid shift
Brief summary
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
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.
Interventions
OTHERInterventional group
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.
OTHERControl group
Standard obesity care with physical activity program
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Obstructive sleep apnea severity at 3 months. | This study includes 2 assessments : baseline (T0) and 3 months (T3) | Obstructive Sleep Apnea change will be assessed with polysomnography system at baseline and after three months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fluid shift | This study includes 2 assessments : baseline (T0) and 3 months (T3) | fluid shift will be assessed by bioimpedance analysis |
| Calf and neck circumferences | This study includes 2 assessments : baseline (T0) and 3 months (T3) | Calf and neck circumferences will be assessed with nonelastic tape |
| Anthropometric parameters | This study includes 2 assessments : baseline (T0) and 3 months (T3) | weight, height, waist and hip circumferences (body weight scale, standing stadiometer and non-elastic tape) |
| Body composition | This study includes 2 assessments : baseline (T0) and 3 months (T3) | fat mass, fat free mass ( by bioimpedance analysis) |
| Upper airway resistances | This study includes 2 assessments : baseline (T0) and 3 months (T3) | upper airway resistance will be assessed by acoustic method |
| Metabolic responses | This study includes 2 assessments : baseline (T0) and 3 months (T3) | Glucose, LDL-Cholesterol, HDL-Cholesterol, Total Cholesterol, Triglycerides (ELISA and RIA technics) |
| Hormonal responses | This study includes 2 assessments : baseline (T0) and 3 months (T3) | Insulin, leptin, adiponectin, catecholamines (ELISA and RIA technics) |
| Inflammatory responses | This study includes 2 assessments : baseline (T0) and 3 months (T3) | C-reactive protein (ELISA and RIA technics) |
| Pulmonary function during exercise | This study includes 2 assessments : baseline (T0) and 3 months (T3) | Incremental maximal exercise in cycling ergometer with respiratory gas assessment (metamax) |
Countries
France
Outcome results
None listed