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

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ClinicalTrials.gov Identifier: NCT02588469
Recruitment Status : Completed
First Posted : October 27, 2015
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

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.

Condition or disease Intervention/treatment Phase
Pediatric Obesity Sleep Apnea, Obstructive Other: Interventional group Other: Control group Not Applicable

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  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of Exercise and Venous Compression on Upper Airway Resistance in Obese Teenagers With Obstructive Sleep Apnea Syndrome
Actual Study Start Date : August 27, 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change from Obstructive sleep apnea severity at 3 months. [ Time Frame: This study includes 2 assessments : baseline (T0) and 3 months (T3) ]
    Obstructive Sleep Apnea change will be assessed with polysomnography system at baseline and after three months


Secondary Outcome Measures :
  1. Upper airway resistances [ Time Frame: This study includes 2 assessments : baseline (T0) and 3 months (T3) ]
    upper airway resistance will be assessed by acoustic method

  2. Fluid shift [ Time Frame: This study includes 2 assessments : baseline (T0) and 3 months (T3) ]
    fluid shift will be assessed by bioimpedance analysis

  3. Calf and neck circumferences [ Time Frame: This study includes 2 assessments : baseline (T0) and 3 months (T3) ]
    Calf and neck circumferences will be assessed with nonelastic tape

  4. Calf and neck circumferences [ Time Frame: This study includes 2 assessments : baseline (T0) and 3 months (T3) ]
    Calf and neck circumferences will be assessed by plethysmography

  5. Anthropometric parameters [ Time Frame: This study includes 2 assessments : baseline (T0) and 3 months (T3) ]
    weight, height, waist and hip circumferences (body weight scale, standing stadiometer and non-elastic tape)

  6. Body composition [ Time Frame: This study includes 2 assessments : baseline (T0) and 3 months (T3) ]
    fat mass, fat free mass ( by bioimpedance analysis)

  7. Pulmonary function during exercise [ Time Frame: This study includes 2 assessments : baseline (T0) and 3 months (T3) ]
    Incremental maximal exercise in cycling ergometer with respiratory gas assessment (metamax)

  8. Metabolic responses [ Time Frame: This study includes 2 assessments : baseline (T0) and 3 months (T3) ]
    Glucose, LDL-Cholesterol, HDL-Cholesterol, Total Cholesterol, Triglycerides (ELISA and RIA technics)

  9. Hormonal responses [ Time Frame: This study includes 2 assessments : baseline (T0) and 3 months (T3) ]
    Insulin, leptin, adiponectin, catecholamines (ELISA and RIA technics)

  10. Inflammatory responses [ Time Frame: This study includes 2 assessments : baseline (T0) and 3 months (T3) ]
    C-reactive protein (ELISA and RIA technics)



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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02588469


Locations
France
Centre de soins de suite et de réadaptation La Beline
Salins-les-Bains, France, 39110
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02588469     History of Changes
Other Study ID Numbers: P/2015/250
First Posted: October 27, 2015    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Centre Hospitalier Universitaire de Besancon:
pediatric obesity
obstructive sleep apnea
physical exercise
compression socks
rostral fluid shift

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Pediatric Obesity
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight