- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07671638
Methodological Study of Exercise and Hypoxic Conditions in Healthy Subjects (ExHyp)
17. juli 2026 opdateret af: University Hospital, Grenoble
The aim of this protocol is to assess physiological responses during various physical exercise protocols (whole-body exercise such as cycling or treadmill running, or localised exercise such as knee extension) and during inhalation of a gas mixtures with various oxygen contents (similar to exposure at high altitude).
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
305
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Samuel Vergès
- Telefonnummer: +33670395773
- E-mail: sverges@chu-grenoble.fr
Studiesteder
-
-
-
La Tronche, Frankrig, 38700
- CReSI (centre de recherche en santé intégrée)
-
Kontakt:
- Samuel VERGES
- Telefonnummer: +33456589900
- E-mail: SVerges@chu-grenoble.fr
-
-
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
- Voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Healthy male or female volunteers
- Aged 18-55
- Body Mass Index <30 kg/m²
- Participants covered by a social security scheme
- Participants capable of signing an informed consent form
- Negative pregnancy test and highly effective contraception for women of childbearing age
Exclusion Criteria:
- Cardiorespiratory, metabolic and neurological disorders, or other conditions assessed during the inclusion consultation that may affect physiological responses to exercise or hypoxia
- Pharmacological treatment taken during the study, other than oral or implantable contraceptive medication for female volunteers of childbearing age
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Exercise and hypoxia
Exercise test performed while inhaling a gas mixture
|
Subjects will perform an exercise test while inhaling a hypoxic gas mixture
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Muscle oxygenation
Tidsramme: During 5 minutes before starting the exercise test, continuously during the exercise test and during 10 minutes immediatly after the end of the exercise test
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Measured by NIRS in % saturation
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During 5 minutes before starting the exercise test, continuously during the exercise test and during 10 minutes immediatly after the end of the exercise test
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Gas exchange
Tidsramme: During 5 minutes before starting the exercise test, continuously during the exercise test and during 10 minutes immediatly after the end of the exercise test
|
Oxygen consumption and cardon dioxide production measured at the mouth, measured in ml/min
|
During 5 minutes before starting the exercise test, continuously during the exercise test and during 10 minutes immediatly after the end of the exercise test
|
|
Heart rate
Tidsramme: During 5 minutes before starting the exercise test, continuously during the exercise test and during 10 minutes immediatly after the end of the exercise test
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Measured by ECG in bpm
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During 5 minutes before starting the exercise test, continuously during the exercise test and during 10 minutes immediatly after the end of the exercise test
|
|
Limb blood flow
Tidsramme: During 5 minutes before starting the exercise test, continuously during the exercise test and during 10 minutes immediatly after the end of the exercise test
|
Measured by Doppler ultrasound in ml/min
|
During 5 minutes before starting the exercise test, continuously during the exercise test and during 10 minutes immediatly after the end of the exercise test
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
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
- Mazzeo RS. Physiological responses to exercise at altitude : an update. Sports Med. 2008;38(1):1-8. doi: 10.2165/00007256-200838010-00001.
- Hansford HJ, Wewege MA, Cashin AG, Hagstrom AD, Clifford BK, McAuley JH, Jones MD. If exercise is medicine, why don't we know the dose? An overview of systematic reviews assessing reporting quality of exercise interventions in health and disease. Br J Sports Med. 2022 Jun;56(12):692-700. doi: 10.1136/bjsports-2021-104977. Epub 2022 Feb 15.
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 (Anslået)
15. september 2026
Primær færdiggørelse (Anslået)
15. september 2031
Studieafslutning (Anslået)
31. marts 2032
Datoer for studieregistrering
Først indsendt
26. maj 2026
Først indsendt, der opfyldte QC-kriterier
22. juni 2026
Først opslået (Faktiske)
26. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
21. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ExHyp
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .