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

Primary Purpose

Pediatric Obesity, Sleep Apnea, Obstructive

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Interventional group
Control group
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pediatric Obesity focused on measuring pediatric obesity, obstructive sleep apnea, physical exercise, compression socks, rostral fluid shift

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre de soins de suite et de réadaptation La Beline

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interventional group

control group

Arm Description

Physical activity program coupled with compression socks wearing during 3 months.

Physical activity program without compression socks during 3 months.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 22, 2015
Last Updated
January 22, 2018
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT02588469
Brief Title
Exercise and Venous Compression on Upper Airway Resistance in Obese Teenagers With OSA
Acronym
OBESOMAC
Official Title
Effects of Exercise and Venous Compression on Upper Airway Resistance in Obese Teenagers With Obstructive Sleep Apnea Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
August 27, 2015 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity, Sleep Apnea, Obstructive
Keywords
pediatric obesity, obstructive sleep apnea, physical exercise, compression socks, rostral fluid shift

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional group
Arm Type
Experimental
Arm Description
Physical activity program coupled with compression socks wearing during 3 months.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Physical activity program without compression socks during 3 months.
Intervention Type
Other
Intervention Name(s)
Interventional group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
Standard obesity care with physical activity program
Primary Outcome Measure Information:
Title
Change from Obstructive sleep apnea severity at 3 months.
Description
Obstructive Sleep Apnea change will be assessed with polysomnography system at baseline and after three months
Time Frame
This study includes 2 assessments : baseline (T0) and 3 months (T3)
Secondary Outcome Measure Information:
Title
Upper airway resistances
Description
upper airway resistance will be assessed by acoustic method
Time Frame
This study includes 2 assessments : baseline (T0) and 3 months (T3)
Title
Fluid shift
Description
fluid shift will be assessed by bioimpedance analysis
Time Frame
This study includes 2 assessments : baseline (T0) and 3 months (T3)
Title
Calf and neck circumferences
Description
Calf and neck circumferences will be assessed with nonelastic tape
Time Frame
This study includes 2 assessments : baseline (T0) and 3 months (T3)
Title
Calf and neck circumferences
Description
Calf and neck circumferences will be assessed by plethysmography
Time Frame
This study includes 2 assessments : baseline (T0) and 3 months (T3)
Title
Anthropometric parameters
Description
weight, height, waist and hip circumferences (body weight scale, standing stadiometer and non-elastic tape)
Time Frame
This study includes 2 assessments : baseline (T0) and 3 months (T3)
Title
Body composition
Description
fat mass, fat free mass ( by bioimpedance analysis)
Time Frame
This study includes 2 assessments : baseline (T0) and 3 months (T3)
Title
Pulmonary function during exercise
Description
Incremental maximal exercise in cycling ergometer with respiratory gas assessment (metamax)
Time Frame
This study includes 2 assessments : baseline (T0) and 3 months (T3)
Title
Metabolic responses
Description
Glucose, LDL-Cholesterol, HDL-Cholesterol, Total Cholesterol, Triglycerides (ELISA and RIA technics)
Time Frame
This study includes 2 assessments : baseline (T0) and 3 months (T3)
Title
Hormonal responses
Description
Insulin, leptin, adiponectin, catecholamines (ELISA and RIA technics)
Time Frame
This study includes 2 assessments : baseline (T0) and 3 months (T3)
Title
Inflammatory responses
Description
C-reactive protein (ELISA and RIA technics)
Time Frame
This study includes 2 assessments : baseline (T0) and 3 months (T3)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Centre de soins de suite et de réadaptation La Beline
City
Salins-les-Bains
ZIP/Postal Code
39110
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32008915
Citation
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.
Results Reference
derived
PubMed Identifier
29852904
Citation
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.
Results Reference
derived

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

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