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OBese Patients With Obstructive Sleep Apnea Syndrome(OSAS) and EXercise Training (OBEX1)

1. oktober 2018 oppdatert av: AGIR à Dom

Comparison of 3 Exercise Training Modalities in Obese Patient With Sleep Apnea Syndrome Treated by Continue Positive Airway Pressure : a Randomized Controlled Study

The study was designed to test the following hypotheses:

In obese patients with OSAS, the benefit of the combination of exercise training + continuous positive airway pressure (CPAP) will be higher than CPAP alone in term of functional capacity, metabolic, inflammatory, cardiovascular and sleep parameters and quality of life.

In obese patients with OSAS, the benefit of training using ventilatory assistance (NIV) during cycloergometer [cycloergometer with NIV] or respiratory muscles training (spirotiger) in addition to cycloergometer [cycloergometer + spirotiger] will be higher than cycloergometer training alone [cycloergometer] in term of functional and exercise capacities.

Dyspnea during walking test and respiratory muscle strength at baseline could influence the response to combined exercise training such as [cycloergometer + NIV] or [cycloergometer + spirotiger]

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Background: Obesity and sleep apnea syndrome lead to metabolic troubles and increasing cardiovascular risk. Furthermore, both diseases are associated with reduced exercise tolerance. We hypothesized that exercise training could be complementary to nocturnal ventilatory treatment in restoring metabolic disturbances, exercise tolerance and sleep parameters in obese patients with SAS.

Objective: To evaluate the effect of training on exercise tolerance (walking distance and dyspnea during walk)(main objective), systemic inflammation, vascular endothelial function, insulin resistance, quality of sleep and quality of life in obese patients treated by CPAP for OSAS (secondary objectives)

Methods: We proposed to conduct a controlled, randomized clinical trial comparing the efficacy of 3 different modalities of training in obese patients with SAS. After a 6-week control pre-inclusion period, patients are included in either [cycloergometer] vs. [cycloergometer with ventilatory assistance] vs. [cycloergometer + respiratory muscle exercises]. Before and after the control period, and both immediately and 9 month after training, patients perform walking test, maximal incremental test on cycloergometer, blood sampling and cardiovascular function, body composition, muscle function, quality of sleep and quality of life assessments as well as spontaneous physical activity measurement. During the 5 years following inclusion in the training program, the number of cardiovascular event is recorded every year.

An interim analysis will be carried out when 30 will have completed the third evaluation session (after the training program). The Peto's method will be used to correct the p-values.

Studietype

Intervensjonell

Registrering (Faktiske)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

  • Canada
      • Quebec, Canada, GIV 4G5
        • Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
  • Frankrike
      • Grenoble, Frankrike, 38043
        • Hopital Universitaire de Grenoble

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

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • OSAS (AHI > 30 before CPAP treatment)
  • > 4h/d CPAP treatment adherence
  • Obese patients with 35 < BMI < 45 kg/m2
  • Patients who give written consent
  • Patients who subscribed social insurance

Exclusion Criteria:

  • Cardiovascular or respiratory failure discovered at the moment of the inclusion in the study
  • Contraindication to exercise
  • Pregnant or breast-feed woman
  • Patients under guardianship
  • Imprisoned patients

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: ERGO
General endurance training on cycloergometer
Annen: Rehabilitation

12 weeks : 3 sessions per week (2 supervised sessions and 1 session at home)

1 technical visit and 1 nursing visit every two months at home for the CPAP
Aktiv komparator: ERGONIV/ ERGOSPIRO
General endurance training on cycloergometer using ventilatory assistance (ERGONIV) or additional respiratory muscle training (ERGOSPIRO)
Annen: Rehabilitation

12 weeks : 3 sessions per week (2 supervised sessions and 1 session at home)

1 technical visit and 1 nursing visit every two months at home for the CPAP

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in exercise tolerance during walking test
Tidsramme: After control period (6th wk) vs. after training period (18th wk)
  • walking distance
  • dyspnea score
After control period (6th wk) vs. after training period (18th wk)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Changes in Aerobic capacity
Tidsramme: After control period (6th wk) vs. after training period (18th and 52th wks)
Maximal oxygen consumption
After control period (6th wk) vs. after training period (18th and 52th wks)
Changes in cardiovascular and metabolic function
Tidsramme: After control period (6th wk) vs. after training period (18th and 52th wks)
Pulse wave velocity, peripheral arterial tone, BP, inflammatory and metabolic plasmatic markers
After control period (6th wk) vs. after training period (18th and 52th wks)
Changes in sleep parameters and Quality Of life
Tidsramme: After control period (6th wk) vs. after training period (18th and 52th wks)
Nocturnal oxygen saturation, CPAP data, Epworth questionnaire, Short Form (36) Health Survey questionnaire
After control period (6th wk) vs. after training period (18th and 52th wks)
Number of cardiovascular events per year
Tidsramme: Every year from the 1st to the 5th year
Questionnaire sent to the patient by mail
Every year from the 1st to the 5th year
Changes in body composition
Tidsramme: After control period (6th wk) vs. after training period (18th and 52th wks)
Fat mass and fat-mass index Fat-free mass and fat-free mass index assessed by impedancemetry measurements
After control period (6th wk) vs. after training period (18th and 52th wks)
Change in physical activity and sleep duration
Tidsramme: After control period (6th wk) vs. after training period (18th and 52th wks)
Number of hour per day of physical activity at 1, 2, 3 or 4 Metabolic Equivalents (METS); Number of steps per day; Sleep to lying position duration ratio
After control period (6th wk) vs. after training period (18th and 52th wks)
Change in exercise tolerance during walking test
Tidsramme: After control period (6th wk) vs. after trainng (52th wk)
  • isotime dyspnea
  • isotime oxygen saturation
After control period (6th wk) vs. after trainng (52th wk)
Change in physiological variables during the control period
Tidsramme: Before (1st) vs. after control period (6th wk)
  • functional and exercise parameters
  • cardiovascular parameters
  • metabolic parameters
  • sleep and quality of life parameters (Short Form (36) Health Survey)
  • physical activity
Before (1st) vs. after control period (6th wk)
Baseline characteristics
Tidsramme: Before control period (1st week) or after the control period (6th week)
  • functional and exercise parameters
  • cardiovascular parameters
  • metabolic parameters
  • sleep and quality of life parameters (Short Form (36) Health Survey)
  • physical activity
Before control period (1st week) or after the control period (6th week)

Samarbeidspartnere og etterforskere

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

Sponsor

AGIR à Dom

Samarbeidspartnere

University Hospital, Grenoble

Etterforskere

  • Hovedetterforsker: Jean-Louis Pépin, MD, PhD, Laboratoire EFCR, CHU de Grenoble, 38043, Grenoble, France

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

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

1. juli 2010

Primær fullføring (Faktiske)

1. desember 2014

Studiet fullført (Forventet)

1. desember 2018

Datoer for studieregistrering

Først innsendt

30. juni 2010

Først innsendt som oppfylte QC-kriteriene

30. juni 2010

Først lagt ut (Anslag)

1. juli 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. oktober 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. oktober 2018

Sist bekreftet

1. september 2018

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • AGIR-03

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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