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

22. januar 2018 opdateret af: Centre Hospitalier Universitaire de Besancon

Effects of Exercise and Venous Compression on Upper Airway Resistance in Obese Teenagers With Obstructive Sleep Apnea Syndrome

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

32

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Salins-les-Bains, Frankrig, 39110
        • Centre de soins de suite et de réadaptation La Beline

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

12 år til 17 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Interventional group
Physical activity program coupled with compression socks wearing during 3 months.
Andet: 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.
Aktiv komparator: control group
Physical activity program without compression socks during 3 months.
Andet: Control group
Standard obesity care with physical activity program

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Obstructive sleep apnea severity at 3 months.
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Upper airway resistances
Tidsramme: This study includes 2 assessments : baseline (T0) and 3 months (T3)
upper airway resistance will be assessed by acoustic method
This study includes 2 assessments : baseline (T0) and 3 months (T3)
Fluid shift
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
This study includes 2 assessments : baseline (T0) and 3 months (T3)
Body composition
Tidsramme: 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
Tidsramme: 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
Tidsramme: This study includes 2 assessments : baseline (T0) and 3 months (T3)
Glucose, LDL-Cholesterol, HDL-Cholesterol, Total Cholesterol, Triglycerides (ELISA and RIA technics)
This study includes 2 assessments : baseline (T0) and 3 months (T3)
Hormonal responses
Tidsramme: This study includes 2 assessments : baseline (T0) and 3 months (T3)
Insulin, leptin, adiponectin, catecholamines (ELISA and RIA technics)
This study includes 2 assessments : baseline (T0) and 3 months (T3)
Inflammatory responses
Tidsramme: This study includes 2 assessments : baseline (T0) and 3 months (T3)
C-reactive protein (ELISA and RIA technics)
This study includes 2 assessments : baseline (T0) and 3 months (T3)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Centre Hospitalier Universitaire de Besancon

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

27. august 2015

Primær færdiggørelse (Faktiske)

1. juni 2016

Studieafslutning (Faktiske)

1. juni 2016

Datoer for studieregistrering

Først indsendt

22. juli 2015

Først indsendt, der opfyldte QC-kriterier

26. oktober 2015

Først opslået (Skøn)

27. oktober 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. januar 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. januar 2018

Sidst verificeret

1. januar 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • P/2015/250

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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