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

C

Centre Hospitalier Universitaire de Besancon

Status

Completed

Conditions

Sleep Apnea, Obstructive
Pediatric Obesity

Treatments

Other: Control group
Other: Interventional group

Study type

Interventional

Funder types

Other

Identifiers

NCT02588469
P/2015/250

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 patients

Sex

All

Ages

12 to 17 years old

Volunteers

No 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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

32 participants in 2 patient groups

Interventional group
Experimental group
Description:
Physical activity program coupled with compression socks wearing during 3 months.
Treatment:
Other: Interventional group
control group
Active Comparator group
Description:
Physical activity program without compression socks during 3 months.
Treatment:
Other: Control group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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