Study of Thermoregulatory Processes in Ultra-endurance Runners in a Hot and Humid Environment

Intensive Sport Clinical Trial

— ERUPTION-2  

Official title:

Study of Thermoregulatory Processes in Ultra-endurance Runners in a Hot and Humid Environment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05098925
• Other study ID #: 2021/CHU/25
• Status: Completed
• Phase: N/A
• Start date: October 19, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2022
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Human beings are characterized by their extraordinary ability to thermoregulate.

During a physical exercise, only 20% of the energy provided by the substrates is converted into muscular mechanical work. The remaining 80% is released as heat. In temperate environments, so-called metabolic heat is dissipated by several physical phenomena (radiation, conduction, convection and evaporation). However, if the dissipation capacity (in a hot and humid environment for example) is lower than the production of metabolic heat, the body temperature increases progressively until exercise stops or heat-related pathologies develop. This pathological entity defined by the acronym EHI for Exertional Heat Illness gather a wide spectrum of clinical forms ranging from oedema or heat rash, to muscle cramps, to syncope; up to more serious forms such as heat exhaustion or heat stroke during exercise.

Heatstroke during exercise is the second most common cause of death in athletes after heart disease.

However, the results of the epidemiological studies and the recommendations are limited to events with effort durations or distances not exceeding those of the marathon. They therefore do not consider ultra-endurance disciplines.

These disciplines, defined by durations of effort of at least 6 hours, have specific characteristics (duration of effort, intensity, steep gradients, exotic destinations, extreme environments) which means that extrapolation of the results and knowledge of the physiology of thermoregulation from "classic" endurance events, such as marathons, to ultra-endurance events is hazardous. There are therefore significant areas of uncertainty in understanding the thermoregulatory function, prevalence of EHI (Exertional Heat Illness) and health implications of ultra-endurance running in a hot environment. This is the context of ERUPTION-2.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 31, 2021
• Est. primary completion date: October 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Runners participating in " La diagonale des fous " race of the "Grand Raid" 2021 on Reunion Island

Exclusion Criteria:

• Runners who do not understand French

Related Conditions & MeSH terms

• Intensive Sport

Intervention

Other:
• Biological testing
Blood sampling, microcapillary sampling, temperature monitoring, saliva testing, EHI questionnaire

Locations

Country	Name	City	State
Réunion	CHU Réunion	Saint-Denis

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion

Country where clinical trial is conducted

Réunion, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Core temperature measurement	Measure of core temperature (°C) will be carried out by continuous monitoring using e-Celsius performance Bodycap technology sensors carried by the athletes through the race	during 3 days of the race
Primary	Natremia measurement	Measure of natremia (blood sodium concentration) will be made by 5 measurements carried out on the eve of the start and during the race, by microcapillary blood sample using the i-STAT technology and CHEM8+ cartridges.	during 3 days of the race
Primary	Hydration saliva measurement	Hydration will be measured 5 times carried out on the eve of the start and during the race using saliva sample to measure the salivary osmolarity with the MX3 testing device.	during 3 days of the race
Primary	Hydration by weight measurement	Weight in kg will be measured 5 times carried out on the eve of the start and during the race	during 3 days of the race