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

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

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.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea, Obstructive; Pediatric Obesity
• Intervention / Treatment: Other: Interventional group; Other: Control group

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Salins-les-Bains, France, 39110
    • Centre de soins de suite et de réadaptation La Beline

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional group; Physical activity program coupled with compression socks wearing during 3 months.	Other: Interventional 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.
Active Comparator: control group; Physical activity program without compression socks during 3 months.	Other: Control group; Standard obesity care with physical activity program

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon

Publications and helpful links

General Publications

• Roche J, Corgosinho FC, Damaso AR, Isacco L, Miguet M, Fillon A, Guyon A, Moreira GA, Pradella-Hallinan M, Tufik S, Tulio de Mello M, Gillet V, Pereira B, Duclos M, Boirie Y, Masurier J, Franco P, Thivel D, Mougin F. Sleep-disordered breathing in adolescents with obesity: When does it start to affect cardiometabolic health? Nutr Metab Cardiovasc Dis. 2020 Apr 12;30(4):683-693. doi: 10.1016/j.numecd.2019.12.003. Epub 2019 Dec 16.
• Roche J, Gillet V, Perret F, Mougin F. Obstructive Sleep Apnea and Sleep Architecture in Adolescents With Severe Obesity: Effects of a 9-Month Lifestyle Modification Program Based on Regular Exercise and a Balanced Diet. J Clin Sleep Med. 2018 Jun 15;14(6):967-976. doi: 10.5664/jcsm.7162.

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: July 22, 2015
• First Submitted That Met QC Criteria: October 26, 2015
• First Posted (Estimate): October 27, 2015

Study Record Updates

• Last Update Posted (Actual): January 24, 2018
• Last Update Submitted That Met QC Criteria: January 22, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: obstructive sleep apnea; physical exercise; compression socks; pediatric obesity; rostral fluid shift
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Signs and Symptoms, Respiratory; Obesity; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Pediatric Obesity
• Other Study ID Numbers: P/2015/250

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO