Not yet recruiting NCT07671638
Methodological Study of Exercise and Hypoxic Conditions in Healthy Subjects
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise and hypoxia.
- Who it may be relevant to
- Registry conditions: Healthy Subjects (HS), Exercise, Hypoxia. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
Interventions
- Combination product Exercise and hypoxia
Subjects will perform an exercise test while inhaling a hypoxic gas mixture
Primary outcome measures
- Muscle oxygenation [Time frame: 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]
Secondary outcome measures (3)
- Gas exchange [Time frame: 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 [Time frame: 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 [Time frame: 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
France · 1 center
- CReSI (centre de recherche en santé intégrée) — La Tronche
Publications
- Mazzeo RS. Physiological responses to exercise at altitude : an update. Sports Med. 2008;38(1):1-8. doi: 10.2165/00007256-200838010-00001. PMID 18081363
- 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. PMID 35168956
Identifiers
NCT: NCT07671638 · ExHyp