NCT01614119

Brief Summary

While the exercise responses are classically described at the cardiorespiratory and muscle levels, recent data suggest that the brain is also significantly stressed by exercise and may even participate to performance limitation. In hypoxia in particular, cerebral responses to exercise may be altered and promote performance reduction during endurance exercise. In the present study, the investigators used innovative approaches to assess cerebral perturbations associated with exercise in hypoxia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 7, 2012

Completed
Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

1.1 years

First QC Date

May 23, 2012

Last Update Submit

December 15, 2025

Conditions

Brain HypoxiaHypoxia

Keywords

CerebralOxygenationPerformanceExercise

Outcome Measures

Primary Outcomes (1)

  • Change in voluntary activation

    Maximum voluntary activation level measured using TMS

    Baseline and after 4h of exercise

Secondary Outcomes (1)

  • Change in tissue oxygenation

    Baseline and after 4 hours of exercise

Study Arms (1)

Sportsmen

EXPERIMENTAL

One single group of active healthy subjects was investigated

Other: Hypoxic exposure

Interventions

Hypoxic exposureOTHER

Subjects breath either normoxic or hypoxic (FiO2 = 12%) gas mixture

Also known as: Hypoxia (FiO2 = 12%)
Sportsmen

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • yrs
  • No cardiovascular, respiratory or neuromuscular disorders

You may not qualify if:

  • Cardiovascular, respiratory or neuromuscular diseases
  • Contraindication for TMS and MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grenoble University Hospital

Grenoble, 38042, France

Location

Related Publications (1)

  • Verges S, Rupp T, Jubeau M, Wuyam B, Esteve F, Levy P, Perrey S, Millet GY. Cerebral perturbations during exercise in hypoxia. Am J Physiol Regul Integr Comp Physiol. 2012 Apr 15;302(8):R903-16. doi: 10.1152/ajpregu.00555.2011. Epub 2012 Feb 8.

    PMID: 22319046RESULT

MeSH Terms

Conditions

Hypoxia, BrainHypoxiaMotor Activity

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Bernard Wuyam, MD PhD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2012

First Posted

June 7, 2012

Study Start

June 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

December 22, 2025

Record last verified: 2025-12

Locations

FR(1)