NCT05098925

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

October 19, 2021

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 28, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 1, 2022

Status Verified

March 1, 2022

Enrollment Period

5 days

First QC Date

September 15, 2021

Last Update Submit

March 31, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (1)

Intervention

EXPERIMENTAL

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

Other: Biological testing

Interventions

Blood sampling, microcapillary sampling, temperature monitoring, saliva testing, EHI questionnaire

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Runners who do not understand French

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Réunion

Saint-Denis, 97400, Reunion

Location

Related Publications (1)

  • Bouscaren N, Berly L, Descombes G, Tounkara B, Lacroix E, Lemarchand B, Racinais S, Millet GY. Thermoregulation and Hydration Dynamics in a 160-km Ultra-Endurance Race in a Tropical Environment: A Field Study on 80 Runners. Sports Med. 2025 Dec 4. doi: 10.1007/s40279-025-02356-6. Online ahead of print.

Study Officials

  • Nicolas Bouscaren, MD

    Centre Hospitalier Universitaire de La REUNION

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2021

First Posted

October 28, 2021

Study Start

October 19, 2021

Primary Completion

October 24, 2021

Study Completion

December 31, 2021

Last Updated

April 1, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations