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CompletedNCT05921864PENTHEREUpdated Sep 8, 2023

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

An observational study in Heat Stress and Heat, sponsored by Direction Centrale du Service de Santé des Armées. Completed at 1 site in France. Open to participants aged 18 Years to 37 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-08.

Sponsored by Direction Centrale du Service de Santé des Armées · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
11
Ages
18 Years to 37 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Heat Stress
  • Heat

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Keywords

  • ultra-endurance
03

In context

Heat Stress Disorders

111 studies on the registry are indexed under Heat Stress Disorders; 45 are open to participants now.

This study's enrollment of 11 is below the median of 55 across 13 observational studies indexed under Heat Stress Disorders.

Browse Heat Stress Disorders studies →

Lead sponsor

Direction Centrale du Service de Santé des Armées is the lead sponsor of 93 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 37 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The study population will be composed of healthy young athletes.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
11 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • OtherPassive heat exposure

    Participants will be exposed to heat in a chamber.

  • OtherActive heat exposure

    Participants will participate to a 6-hour run.

06

What researchers measure

Primary outcomes

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

    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.

    Time frame: Through study completion (1 month)

07

Study locations

1 site
  • Institut de Recherche Biomédicale des Armées
    Brétigny-sur-Orge, 91223, France
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05921864
Lead sponsor
Direction Centrale du Service de Santé des Armées
Responsible party
Sponsor
First posted
Jun 27, 2023
Start date
Jun 19, 2023
Primary completion
Jul 22, 2023
Completion
Jul 22, 2023
Last update
Sep 8, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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