NCT02880150

Brief Summary

Climbing at high altitude and tolerating hypoxic environment require specific physiological adaptations. Large intersubjects differences exist regarding the ability to adapt to high altitude and hypoxia. The present study aims to characterise the physiological responses to hypoxia in a group of elite climbers by comparison to sea level athletes. We hypothesised that elite climbers would show better physiological responses to hypoxia and more preserved performances compared to sea level.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2013

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

May 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
2.3 years until next milestone

First Posted

Study publicly available on registry

August 26, 2016

Completed
Last Updated

August 26, 2016

Status Verified

August 1, 2016

Enrollment Period

10 months

First QC Date

October 21, 2013

Last Update Submit

August 22, 2016

Conditions

HypoxiaExerciseSport Performance

Keywords

elite climbersnear infrared spectroscopy

Outcome Measures

Primary Outcomes (1)

  • Performance reduction in hypoxia versus normoxia

    Difference in maximal cycling power output between the normoxic and the hypoxic exercise test

    Day one on the evaluation day

Secondary Outcomes (1)

  • Near infrared signals during exercise

    Day one on the evaluation day

Study Arms (2)

Elite climbers

OTHER

Elite climbers selected in a national group for their previous performances at high altitude

Other: Stress test

Sea level sportsmen

OTHER

Control group with similar anthropometric, age, gender and maximal normoxic oxygen consumption that the elite climber group

Other: Stress test

Interventions

Stress testOTHER
Elite climbersSea level sportsmen

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 and 40
  • Member of the national high altitude climbing group

You may not qualify if:

  • Any diseases incompatible with hypoxic exposure, exercise testing
  • Pregnancy

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: 22319046BACKGROUND

MeSH Terms

Conditions

HypoxiaMotor Activity

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2013

First Posted

August 26, 2016

Study Start

May 1, 2013

Primary Completion

March 1, 2014

Study Completion

May 1, 2014

Last Updated

August 26, 2016

Record last verified: 2016-08

Locations

FR(1)