- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07671638
Methodological Study of Exercise and Hypoxic Conditions in Healthy Subjects (ExHyp)
July 17, 2026 updated by: 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).
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
305
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Samuel Vergès
- Phone Number: +33670395773
- Email: sverges@chu-grenoble.fr
Study Locations
-
-
-
La Tronche, France, 38700
- CReSI (centre de recherche en santé intégrée)
-
Contact:
- Samuel VERGES
- Phone Number: +33456589900
- Email: SVerges@chu-grenoble.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercise and hypoxia
Exercise test performed while inhaling a gas mixture
|
Subjects will perform an exercise test while inhaling a hypoxic gas mixture
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Measured by NIRS in % saturation
|
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
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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
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
|
Measured by ECG in bpm
|
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
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 15, 2026
Primary Completion (Estimated)
September 15, 2031
Study Completion (Estimated)
March 31, 2032
Study Registration Dates
First Submitted
May 26, 2026
First Submitted That Met QC Criteria
June 22, 2026
First Posted (Actual)
June 26, 2026
Study Record Updates
Last Update Posted (Actual)
July 21, 2026
Last Update Submitted That Met QC Criteria
July 17, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ExHyp
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.