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

Heat Stress Clinical Trial

— PENTHERE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05921864
• Other study ID #: 2023PBMD05
• Secondary ID: 2023-A00730-45
• Status: Completed
• Start date: June 19, 2023
• Est. completion date: July 22, 2023

Study information

• Verified date: September 2023
• Source: Direction Centrale du Service de Santé des Armées
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: July 22, 2023
• Est. primary completion date: July 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 37 Years

Eligibility

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

Related Conditions & MeSH terms

• Heat
• Heat Stress
• Heat Stress Disorders

Intervention

Other:
• Passive heat exposure
Participants will be exposed to heat in a chamber.
• Active heat exposure
Participants will participate to a 6-hour run.

Locations

Country	Name	City	State
France	Institut de Recherche Biomédicale des Armées	Brétigny-sur-Orge

Sponsors (1)

Lead Sponsor	Collaborator
Direction Centrale du Service de Santé des Armées

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Through study completion (1 month)