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

NCT ID: NCT02588469

Last Updated: 2018-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-27
• Study Completion Date: 2016-06-30

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.

Conditions

Pediatric Obesity; Sleep Apnea, Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Interventional group

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

Group Type: EXPERIMENTAL

Interventional group

Intervention Type: 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.

control group

Physical activity program without compression socks during 3 months.

Group Type: ACTIVE_COMPARATOR

Control group

Intervention Type: OTHER

Standard obesity care with physical activity program

Interventions

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.

Intervention Type: OTHER

Control group

Standard obesity care with physical activity program

Intervention Type: OTHER

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre de soins de suite et de réadaptation La Beline

Salins-les-Bains, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 32008915 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29852904 (View on PubMed)

Other Identifiers

P/2015/250

Identifier Type: -

Identifier Source: org_study_id