- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02588469
Exercise and Venous Compression on Upper Airway Resistance in Obese Teenagers With OSA (OBESOMAC)
Effects of Exercise and Venous Compression on Upper Airway Resistance in Obese Teenagers With Obstructive Sleep Apnea Syndrome
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Salins-les-Bains, Francie, 39110
- Centre de soins de suite et de réadaptation La Beline
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: Interventional group
Physical activity program coupled with compression socks wearing during 3 months.
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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. |
Aktivní komparátor: control group
Physical activity program without compression socks during 3 months.
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Standard obesity care with physical activity program
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Change from Obstructive sleep apnea severity at 3 months.
Časové okno: 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
|
This study includes 2 assessments : baseline (T0) and 3 months (T3)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Upper airway resistances
Časové okno: This study includes 2 assessments : baseline (T0) and 3 months (T3)
|
upper airway resistance will be assessed by acoustic method
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This study includes 2 assessments : baseline (T0) and 3 months (T3)
|
Fluid shift
Časové okno: This study includes 2 assessments : baseline (T0) and 3 months (T3)
|
fluid shift will be assessed by bioimpedance analysis
|
This study includes 2 assessments : baseline (T0) and 3 months (T3)
|
Calf and neck circumferences
Časové okno: This study includes 2 assessments : baseline (T0) and 3 months (T3)
|
Calf and neck circumferences will be assessed with nonelastic tape
|
This study includes 2 assessments : baseline (T0) and 3 months (T3)
|
Calf and neck circumferences
Časové okno: This study includes 2 assessments : baseline (T0) and 3 months (T3)
|
Calf and neck circumferences will be assessed by plethysmography
|
This study includes 2 assessments : baseline (T0) and 3 months (T3)
|
Anthropometric parameters
Časové okno: 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)
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This study includes 2 assessments : baseline (T0) and 3 months (T3)
|
Body composition
Časové okno: This study includes 2 assessments : baseline (T0) and 3 months (T3)
|
fat mass, fat free mass ( by bioimpedance analysis)
|
This study includes 2 assessments : baseline (T0) and 3 months (T3)
|
Pulmonary function during exercise
Časové okno: This study includes 2 assessments : baseline (T0) and 3 months (T3)
|
Incremental maximal exercise in cycling ergometer with respiratory gas assessment (metamax)
|
This study includes 2 assessments : baseline (T0) and 3 months (T3)
|
Metabolic responses
Časové okno: This study includes 2 assessments : baseline (T0) and 3 months (T3)
|
Glucose, LDL-Cholesterol, HDL-Cholesterol, Total Cholesterol, Triglycerides (ELISA and RIA technics)
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This study includes 2 assessments : baseline (T0) and 3 months (T3)
|
Hormonal responses
Časové okno: This study includes 2 assessments : baseline (T0) and 3 months (T3)
|
Insulin, leptin, adiponectin, catecholamines (ELISA and RIA technics)
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This study includes 2 assessments : baseline (T0) and 3 months (T3)
|
Inflammatory responses
Časové okno: This study includes 2 assessments : baseline (T0) and 3 months (T3)
|
C-reactive protein (ELISA and RIA technics)
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This study includes 2 assessments : baseline (T0) and 3 months (T3)
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Spolupracovníci a vyšetřovatelé
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- P/2015/250
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