Study of Biomarkers of Heat Tolerance and Recovery During Ultra-endurance Exercise (PENTHERE)

September 7, 2023 updated by: Direction Centrale du Service de Santé des Armées
Military personnel are called upon to serve in hot, dry or humid climates, which places great demands on their ability to tolerate heat. Induced heat stress can impair performance and lead to pathologies. Faced with the challenges of global warming, this issue is becoming increasingly important in the practice of sport. While hyperthermia is known to impair endurance performance, the underlying thermophysiological responses and regulatory mechanisms during prolonged exercise remain poorly understood. The effects of hyperthermia on mental performance raise questions about the degradation of interoceptive capacities and the deleterious impact on behavioral regulation, an important component of thermal risk management in ultra-endurance exercise. What's more, despite the muscular and hydromineral consequences (rhabdomyolysis, renal failure, dehydration) of prolonged exercise, few data are available on recovery kinetics. A better understanding of the factors conditioning recovery quality could help limit the deleterious consequences of ultra-endurance exercise.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

11

Contacts and Locations

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

Study Locations

  • France
      • Brétigny-sur-Orge, France, 91223
        • Institut de Recherche Biomédicale des Armées

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population will be composed of healthy young athletes.

Description

Inclusion Criteria:

  • Healthy individuals
  • BMI between 18 and 25 kg/m2
  • Weight ≥ 51 kg
  • Minimum training volume 6 days/7, aerobic
  • Participation in a running competition ≥ 6hours
  • Having given informed consent

Exclusion Criteria:

  • Presence or history of medical pathology
  • Presence of significant deviation from normal electrocardiogram values
  • History of heat stroke
  • Known intolerance to heat
  • Inability to swallow a capsule or refusal of rectal probe
  • Alcohol consumption exceeding the equivalent of 3 glasses of wine per week
  • Consumption of narcotics
  • Smoking > 0.5 pack of cigarettes per day
  • On usual medication
  • Pregnant or breast-feeding women
  • Protected adult, under legal protection, guardianship or curatorship, or unable to give personal written consent

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of correlation between core temperature measured at the end of passive heat exposure and that measured at the end of active heat exposure
Time Frame: Through study completion (1 month)
Core temperature will be measured in every participants at the end of passive heat exposure and at the end of active heat exposure. A correlation analysis will be performed on these measurements.
Through study completion (1 month)

Collaborators and Investigators

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

Sponsor

Direction Centrale du Service de Santé des Armées

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)

June 19, 2023

Primary Completion (Actual)

July 22, 2023

Study Completion (Actual)

July 22, 2023

Study Registration Dates

First Submitted

June 16, 2023

First Submitted That Met QC Criteria

June 16, 2023

First Posted (Actual)

June 27, 2023

Study Record Updates

Last Update Posted (Actual)

September 8, 2023

Last Update Submitted That Met QC Criteria

September 7, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023PBMD05
  • 2023-A00730-45 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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