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

Not Applicable

Completed

• Conditions: Sleep Apnea, Obstructive; Pediatric Obesity
• Interventions: Other: Interventional group; Other: Control group

• Registration Number: NCT02588469
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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.

Study Timeline

• Study First Submitted: 2015-07-22
• Study Start: 2015-08-27
• Study First Submitted QC: 2015-10-26
• Study First Posted: 2015-10-27
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-22
• Last Update Posted: 2018-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional group	Interventional group	Physical activity program coupled with compression socks wearing during 3 months.
control group	Control group	Physical activity program without compression socks during 3 months.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Inflammatory responses	This study includes 2 assessments : baseline (T0) and 3 months (T3)	C-reactive protein (ELISA and RIA technics)
Body composition	This study includes 2 assessments : baseline (T0) and 3 months (T3)	fat mass, fat free mass ( by bioimpedance analysis)
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)
Upper airway resistances	This study includes 2 assessments : baseline (T0) and 3 months (T3)	upper airway resistance will be assessed by acoustic method
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 by plethysmography
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)
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)

Trial Locations

Locations (1)

Centre de soins de suite et de réadaptation La Beline; 🇫🇷 Salins-les-Bains, France