Power-speed-endurance Profile (Cycling/Rowing) : Optimize Performance of the French Athletes at the Paris Olympics 2024 (THPCA2024)

October 24, 2024 updated by: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Le Bourget-du-Lac, France, 73370
        • CEPART
      • Nantes, France, 44000
        • CHU Nantes
      • Saint-Étienne, France, 42055
        • CHU Saint-Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Track cyclists and rowers (males and females)
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximum force produced at zero speed in a fatigue-free condition
Time Frame: Month : 3
F0i measurement
Month : 3
Speed in a fatigue-free condition
Time Frame: Month : 3
V0i measurement
Month : 3
Maximum force produced at zero speed at the end of the 3 min.
Time Frame: Month : 3
F0e measurement
Month : 3
Speed up produced at the end of the 3 min.
Time Frame: Month : 3
V0e measurement
Month : 3

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximal oxygen uptake (VO2max)
Time Frame: At inclusion
Cardiac stress test
At inclusion
Maximal Ventilation (VEmax)
Time Frame: At inclusion
Cardiac stress test
At inclusion
Cardiac output (QCmax)
Time Frame: At inclusion
Cardiac stress test
At inclusion
Maximal cardiac frequency (fcmax)
Time Frame: At inclusion
Cardiac stress test
At inclusion
Fibre type determination
Time Frame: Month : 2
Muscle biopsy of the vastus lateralis
Month : 2
Microvasculature analysis
Time Frame: Month : 2
Muscle biopsy of the vastus lateralis
Month : 2
Muscle enzyme activity (Phosphofructokinase (PFK), lactate dehydrogenase (LDH), citrate synthase (CS) et cyclo-oxygenase (COx))
Time Frame: Month : 2
Muscle biopsy of the vastus lateralis
Month : 2
Maximal voluntary force (N)
Time Frame: Month : 9
Comparison before and after exercise
Month : 9
Rate of force development
Time Frame: Month : 9
Comparison of force development
Month : 9
Evoked forces (N)
Time Frame: Month : 9
Ratio of evoked force at low and high frequencies
Month : 9
Maximum force produced at zero speed in a fatigue-free condition after bicarbonate ingestion
Time Frame: Month : 3
F0i measurement
Month : 3
Speed in a fatigue-free condition after bicarbonate ingestion
Time Frame: Month : 3
V0i measurement
Month : 3
Maximum force produced at zero speed at the end of the 3 min after bicarbonate ingestion
Time Frame: Month : 3
F0e measurement
Month : 3
Speed up produced at the end of the 3 min after bicarbonate ingestion
Time Frame: Month : 3
V0i measurement
Month : 3
Maximal oxygen uptake (VO2max) after bicarbonate ingestion
Time Frame: At inclusion
Cardiac stress test
At inclusion
Maximal Ventilation (VEmax) after bicarbonate ingestion
Time Frame: At inclusion
Cardiac stress test
At inclusion
Cardiac output (QCmax) after bicarbonate ingestion
Time Frame: At inclusion
Cardiac stress test
At inclusion
Maximal cardiac frequency (fcmax) after bicarbonate ingestion
Time Frame: At inclusion
Cardiac stress test
At inclusion
Fibre type determination after bicarbonate ingestion
Time Frame: Month : 2
Muscle biopsy of the vastus lateralis
Month : 2
Microvasculature analysis after bicarbonate ingestion
Time Frame: Month : 2
Muscle biopsy of the vastus lateralis
Month : 2
Muscle enzyme activity (Phosphofructokinase (PFK), lactate dehydrogenase (LDH), citrate synthase (CS) et cyclo-oxygenase (COx)) after bicarbonate ingestion
Time Frame: Month : 2
Muscle biopsy of the vastus lateralis
Month : 2
Maximal voluntary force (N) after bicarbonate ingestion
Time Frame: Month : 9
Comparison before and after exercise
Month : 9
Rate of force development after bicarbonate ingestion
Time Frame: Month : 9
Comparison of force development
Month : 9
Evoked forces (N) after bicarbonate ingestion
Time Frame: Month : 9
Ratio of evoked force at low and high frequencies
Month : 9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Saint Etienne

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Léonard FEASSON, PhD, CHU Saint-Etienne
  • Study Director: Laurent MESSONNIER, PhD, Université Savoie Mont Blanc, CHAMBERY

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 29, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 11, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 11, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21CH145
  • 2021-A02341-40 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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