Viewing Study NCT05847465



Ignite Creation Date: 2024-05-06 @ 6:57 PM
Last Modification Date: 2024-10-26 @ 2:58 PM
Study NCT ID: NCT05847465
Status: RECRUITING
Last Update Posted: 2023-08-02
First Post: 2023-04-27

Brief Title: Study of Thermoregulation in Exercise Heat Stroke in the Military Environment
Sponsor: Direction Centrale du Service de Santé des Armées
Organization: Direction Centrale du Service de Santé des Armées

Study Overview

Official Title: Study of Thermoregulation in Exercise Heat Stroke in the Military Environment
Status: RECRUITING
Status Verified Date: 2023-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: EXPLO-MITO
Brief Summary: The EXPLO-MITO study is an ancillary study from the main EXPLO-CCE study NCT04593316 IDRCB 2020-A01967-32

The Heat Tolerance Test HTT is a physiological exploration that has several advantages for use in research and clinical settings Unlike the walk-run test it is performed under controlled conditions both environmentally temperature control humidity etc and in terms of effort intensity In addition there are published interpretation criteria for this test allowing to characterize thermoregulation profiles and to distinguish between Heat Intolerant HI and Heat Tolerant HT patients

The reproducibility of this test and its performance in a climatic chamber allows a true comparison of thermophysiological responses heart rate rectal and skin temperatures skin blood flow and sweat loss which was not possible with the run-walk test which was more a field test validating a physical aptitude for recovery so-called occupational test than a physiological exploration evaluating a response to stress by comparing it with the expected response in a population of young healthy properly trained subjects Moreover the HTT is a much less physiologically demanding test than the 8-km run The HTT which corresponds to a 2-hour walk at 5 kmh with a 2 slope at 40C and 40 relative humidity is a so-called compensable thermal stress that is under these conditions of exercise and environment when the individual has normal thermoregulatory capacities a thermal equilibrium plateau is reached during the second hour when the individuals thermolysis capacities make it possible to compensate for the production of heat by the exercise and the gain of heat related to the environment On average this plateau is between 38 and 39C This is clearly not the case with our experience of physiological monitoring of the 8-km walk-run which rarely allows a temperature plateau to be reached and is accompanied by a temperature rise constantly above 39C In addition to being performed in the laboratory this test is therefore completely safe

For all these reasons reproducibility relevance predictive value of recurrence this test has been used for more than 30 years by the Israeli army for the assessment of these cases of exercise heat stroke before their return to work There is therefore a fair amount of published data and hindsight on the use and interest of this test The Israeli test has the highest level of recommendation Grade A of all the other published heat tolerance tests Also the availability of a climatic chamber means that this test can now be proposed as one of the explorations available to clinicians who have to decide on the fitness of soldiers after exercise heat stroke
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
2023-A00156-39 OTHER IDRCB None