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OpenTrials
Completed

NCT Number: NCT05921864

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

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.

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Key information

Age range

18 year–37 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut de Recherche Biomédicale des Armées

Brétigny-sur-Orge, 91223, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Passive heat exposure

Other

Participants will be exposed to heat in a chamber.

Active heat exposure

Other

Participants will participate to a 6-hour run.

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

    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.

Sponsors and collaborators

Lead sponsor

Direction Centrale du Service de Santé des Armées

Other

Registry information

Acronym: PENTHERE

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 27, 2023
Registry last updated
Sep 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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