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

Sponsor

Direction Centrale du Service de Santé des Armées (Other)

Overall Status

Recruiting

CT.gov ID

NCT05921864

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Days)

45.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Heat Stress Heat	Other: Passive heat exposure Other: Active heat exposure

Study Design

Study Type:

Observational

Anticipated Enrollment :

18 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 19, 2023

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Outcome Measures

Primary Outcome Measures

Degree of correlation between core temperature measured at the end of passive heat exposure and that measured at the end of active heat exposure [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 37 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut de Recherche Biomédicale des Armées	Brétigny-sur-Orge		France	91223

Sponsors and Collaborators

Direction Centrale du Service de Santé des Armées

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Direction Centrale du Service de Santé des Armées

ClinicalTrials.gov Identifier:

NCT05921864

Other Study ID Numbers:

2023PBMD05
2023-A00730-45

First Posted:

Jun 27, 2023

Last Update Posted:

Jun 29, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Direction Centrale du Service de Santé des Armées

ultra-endurance

Additional relevant MeSH terms:

Heat Stress Disorders

Study Results

No Results Posted as of Jun 29, 2023