NCT07671638

Brief Summary

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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
305

participants targeted

Target at P75+ for not_applicable

Timeline
67mo left

Started Sep 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 26, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

September 15, 2026

Expected
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2031

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2032

Last Updated

July 21, 2026

Status Verified

July 1, 2026

Enrollment Period

5 years

First QC Date

May 26, 2026

Last Update Submit

July 17, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Muscle oxygenation

    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 Outcomes (3)

  • Gas exchange

    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

    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

    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

Study Arms (1)

Exercise and hypoxia

EXPERIMENTAL

Exercise test performed while inhaling a gas mixture

Combination Product: Exercise and hypoxia

Interventions

Exercise and hypoxiaCOMBINATION_PRODUCT

Subjects will perform an exercise test while inhaling a hypoxic gas mixture

Exercise and hypoxia

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Pharmacological treatment taken during the study, other than oral or implantable contraceptive medication for female volunteers of childbearing age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CReSI (centre de recherche en santé intégrée)

La Tronche, 38700, France

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Motor ActivityHypoxia

Interventions

Exercise

Condition Hierarchy (Ancestors)

BehaviorSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2026

First Posted

June 26, 2026

Study Start (Estimated)

September 15, 2026

Primary Completion (Estimated)

September 15, 2031

Study Completion (Estimated)

March 31, 2032

Last Updated

July 21, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations