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Healthy VolunteersTHPCA2024NCT05314543

Power-speed-endurance Profile (Cycling/Rowing) : Optimize Performance of the French Athletes at the Paris Olympics 2024

A study testing Hypoxia in people with Healthy Volunteers and Performance, run by Centre Hospitalier Universitaire de Saint Etienne at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers, Performance
What is being tested?
Hypoxia
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
3 sitesFrance
Study dates
29 Nov 2021to 11 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

France3 sites

  • CEPART

    Le Bourget-du-Lac, 73370

  • Chu Nantes

    Nantes, 44000

  • Chu Saint-Etienne

    Saint-Etienne, 42055

Other trials in France

About this study

Official title: Description and Determinants of the Power-speed-endurance Profile (PVE) in Cycling and Rowing to Optimize the Performance of the French Athletes at the Paris Olympics 2024

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.

Read the detailed description

The objective of this study is to evaluate the maximum capacity of power production of athletes by describing their power-endurance profile and the physiological factors underlying this maximum power generation capacity. These assessments will guide coaches and athletes for:

  1. the best use of athletes' physical abilities (for race strategy, cycling gear ratio or rowing levers)
  2. adaptation of training program to improve the maximum capacity of power production of the athletes, in order to increase the number of medals at the Paris Olympics 2024.
Being tested
Hypoxia
Keywords
Biomechanics, Track cyclists and rowers, Energetics, Muscle, Fatigue
Medical subject headings
Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT05314543
Study groupRoleWhat they receive
Track cyclists and rowers (males and females)ExperimentalAll 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.
Receives: Other: Hypoxia

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    F0i measurement

    Measured: Month : 3

  2. Speed in a fatigue-free condition

    V0i measurement

    Measured: Month : 3

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

    F0e measurement

    Measured: Month : 3

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

    V0e measurement

    Measured: Month : 3

Secondary outcomes (24)

  1. Maximal oxygen uptake (VO2max)

    Cardiac stress test

    Measured: At inclusion

  2. Maximal Ventilation (VEmax)

    Cardiac stress test

    Measured: At inclusion

  3. Cardiac output (QCmax)

    Cardiac stress test

    Measured: At inclusion

  4. Maximal cardiac frequency (fcmax)

    Cardiac stress test

    Measured: At inclusion

  5. Fibre type determination

    Muscle biopsy of the vastus lateralis

    Measured: Month : 2

  6. Microvasculature analysis

    Muscle biopsy of the vastus lateralis

    Measured: Month : 2

  7. Muscle enzyme activity (Phosphofructokinase (PFK), lactate dehydrogenase (LDH), citrate synthase (CS) et cyclo-oxygenase (COx))

    Muscle biopsy of the vastus lateralis

    Measured: Month : 2

  8. Maximal voluntary force (N)

    Comparison before and after exercise

    Measured: Month : 9

  9. Rate of force development

    Comparison of force development

    Measured: Month : 9

  10. Evoked forces (N)

    Ratio of evoked force at low and high frequencies

    Measured: Month : 9

  11. Maximum force produced at zero speed in a fatigue-free condition after bicarbonate ingestion

    F0i measurement

    Measured: Month : 3

  12. Speed in a fatigue-free condition after bicarbonate ingestion

    V0i measurement

    Measured: Month : 3

  13. Maximum force produced at zero speed at the end of the 3 min after bicarbonate ingestion

    F0e measurement

    Measured: Month : 3

  14. Speed up produced at the end of the 3 min after bicarbonate ingestion

    V0i measurement

    Measured: Month : 3

  15. Maximal oxygen uptake (VO2max) after bicarbonate ingestion

    Cardiac stress test

    Measured: At inclusion

  16. Maximal Ventilation (VEmax) after bicarbonate ingestion

    Cardiac stress test

    Measured: At inclusion

  17. Cardiac output (QCmax) after bicarbonate ingestion

    Cardiac stress test

    Measured: At inclusion

  18. Maximal cardiac frequency (fcmax) after bicarbonate ingestion

    Cardiac stress test

    Measured: At inclusion

  19. Fibre type determination after bicarbonate ingestion

    Muscle biopsy of the vastus lateralis

    Measured: Month : 2

  20. Microvasculature analysis after bicarbonate ingestion

    Muscle biopsy of the vastus lateralis

    Measured: Month : 2

  21. Muscle enzyme activity (Phosphofructokinase (PFK), lactate dehydrogenase (LDH), citrate synthase (CS) et cyclo-oxygenase (COx)) after bicarbonate ingestion

    Muscle biopsy of the vastus lateralis

    Measured: Month : 2

  22. Maximal voluntary force (N) after bicarbonate ingestion

    Comparison before and after exercise

    Measured: Month : 9

  23. Rate of force development after bicarbonate ingestion

    Comparison of force development

    Measured: Month : 9

  24. Evoked forces (N) after bicarbonate ingestion

    Ratio of evoked force at low and high frequencies

    Measured: Month : 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2022
  2. Study start29 Nov 2021
  3. Primary completion11 Aug 2024
  4. Study completion11 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
This is a prospective multi-center exploratory pilot study of physiology study on athletes, track cyclists or rowers national to international level competitors.
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05314543
Sponsor's protocol ID
21CH145
Other IDs
2021-A02341-40
Acronym
THPCA2024
Status last verified
Oct 2024
First submitted
2 Feb 2022
Last updated
26 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Blervaque L, Merlet AN, Maciejewski H, Feasson L, Messonnier LA. Capillary-to-sarcolemma distance and location of cytochrome c oxidase: Insights for maximal O2 uptake and muscle lactate release in trained athletes. J Physiol. 2025 Jul;603(14):3945-3960. doi: 10.1113/JP288318. Epub 2025 Jul 2.

    PubMed 40605256

Questions about this trial

What is this clinical trial studying?

A study testing Hypoxia in people with Healthy Volunteers and Performance, run by Centre Hospitalier Universitaire de Saint Etienne at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum force produced at zero speed in a fatigue-free condition (time frame: Month : 3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05314543, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.

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