NCT05314543

Brief Summary

As part of the preparation at the Paris 2024 Olympic Games, the French rowing and cycling federations and a consortium of researchers met to reach an ultimate goal: to increase the number of medals in these two disciplines for Paris 2024 Olympics.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable healthy-volunteers

Timeline
Completed

Started Nov 2021

Longer than P75 for not_applicable healthy-volunteers

Geographic Reach
1 country

3 active sites

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

November 29, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2024

Completed
Last Updated

October 26, 2024

Status Verified

October 1, 2024

Enrollment Period

2.7 years

First QC Date

February 2, 2022

Last Update Submit

October 24, 2024

Conditions

Keywords

BiomechanicsTrack cyclists and rowersEnergeticsMuscleFatigue

Outcome Measures

Primary Outcomes (4)

  • Maximum force produced at zero speed in a fatigue-free condition

    F0i measurement

    Month : 3

  • Speed in a fatigue-free condition

    V0i measurement

    Month : 3

  • Maximum force produced at zero speed at the end of the 3 min.

    F0e measurement

    Month : 3

  • Speed up produced at the end of the 3 min.

    V0e measurement

    Month : 3

Secondary Outcomes (24)

  • Maximal oxygen uptake (VO2max)

    At inclusion

  • Maximal Ventilation (VEmax)

    At inclusion

  • Cardiac output (QCmax)

    At inclusion

  • Maximal cardiac frequency (fcmax)

    At inclusion

  • Fibre type determination

    Month : 2

  • +19 more secondary outcomes

Study Arms (1)

Track cyclists and rowers (males and females)

EXPERIMENTAL

All female and male rowing and track cycling athletes at the national or international national or international level, registered in a selection process and likely to represent France at the likely to represent France at the 2024 Olympics will be asked to take part to take part in this study.

Other: Hypoxia

Interventions

HypoxiaOTHER

Subjects will be subjected to mild hypoxia simulating an altitude of 1750 m (normobaric hypoxia). Hypoxia decreases oxygen supply to tissue and limit exercise capacity. For this, the subjects will inhale a gas mixture depleted in oxygen (enriched in nitrogen). The barometric pressure at 1500 m being 621 mmHg, PIO2 at this altitude (PIO2 = (621 - 47) x 21%) is 120.5 mmHg. For sea level altitude where the barometric pressure is 760 mmHg, the hypoxic gas mixture should contain (x = 120.5 / (760 - 47)) 16.8% O2. Thus, by inhaling a gas mixture that is oxygen-depleted from 21 to 16.8%, subjects (will simulate the altitude of 1750 and) will experience the equivalent of a 20% reduction in oxygen supply.

Track cyclists and rowers (males and females)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • experienced, well-trained (national to international level) rowers and cyclists
  • written consent

You may not qualify if:

  • taking medications interfering with measured parameters
  • contraindication to competitive sport practice
  • currently participating in an other structured exercise program
  • muscular, bone or joint injuries
  • neurologic disease
  • pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CEPART

Le Bourget-du-Lac, 73370, France

Location

Chu Nantes

Nantes, 44000, France

Location

Chu Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Léonard FEASSON, PhD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR
  • Laurent MESSONNIER, PhD

    Université Savoie Mont Blanc, CHAMBERY

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: This is a prospective multi-center exploratory pilot study of physiology study on athletes, track cyclists or rowers national to international level competitors.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2022

First Posted

April 6, 2022

Study Start

November 29, 2021

Primary Completion

August 11, 2024

Study Completion

August 11, 2024

Last Updated

October 26, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations