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

NCT02588469 | Completed

• 1 other identifier: P/2015/250
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Obesity; Sleep Apnea, Obstructive

Keywords

pediatric obesity; obstructive sleep apnea; physical exercise; compression socks; rostral fluid shift

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Upper airway resistances

  This study includes 2 assessments : baseline (T0) and 3 months (T3)

• Fluid shift

  This study includes 2 assessments : baseline (T0) and 3 months (T3)

• Calf and neck circumferences

  This study includes 2 assessments : baseline (T0) and 3 months (T3)

• Calf and neck circumferences

  This study includes 2 assessments : baseline (T0) and 3 months (T3)

• Anthropometric parameters

  This study includes 2 assessments : baseline (T0) and 3 months (T3)

Study Arms (2)

Interventional group

EXPERIMENTAL

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

Other: Interventional group

control group

ACTIVE COMPARATOR

Physical activity program without compression socks during 3 months.

Other: Control group

Interventions

Interventional group OTHER

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.

Interventional group

Control group OTHER

Standard obesity care with physical activity program

control group

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

Centre de soins de suite et de réadaptation La Beline

Salins-les-Bains, 39110, France

Location

Related Publications (2)

• 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.

  PMID: 32008915 DERIVED

• 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.

  PMID: 29852904 DERIVED

MeSH Terms

Conditions

Pediatric Obesity; Sleep Apnea, Obstructive; Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2015
• First Posted: October 27, 2015
• Study Start: August 27, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: January 24, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)