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

22. januar 2018 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

32

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

12 år til 17 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Interventional group
Physical activity program coupled with compression socks wearing during 3 months.
Annen: 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.
Annen: Control group
Standard obesity care with physical activity program

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Centre Hospitalier Universitaire de Besancon

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

27. august 2015

Primær fullføring (Faktiske)

1. juni 2016

Studiet fullført (Faktiske)

1. juni 2016

Datoer for studieregistrering

Først innsendt

22. juli 2015

Først innsendt som oppfylte QC-kriteriene

26. oktober 2015

Først lagt ut (Anslag)

27. oktober 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

24. januar 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. januar 2018

Sist bekreftet

1. januar 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • P/2015/250

Plan for individuelle deltakerdata (IPD)

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NEI

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