NCT05847465 Study of Thermoregulation in Exercise Heat Stroke in the Military Environment
| NCT ID | NCT05847465 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Direction Centrale du Service de Santé des Armées |
| Condition | Heat Stroke |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-05-09 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2023-05-09 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 km/h with a 2% slope at 40°C 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 individual's 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 39°C. 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 39°C. 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.
Eligibility Criteria
Inclusion Criteria: * Be included in the main EXPLO-CCE study; * Subject trained or re-trained at 2 aerobic sessions per week; * At least 2 months from the exercise heat stroke experience Exclusion Criteria: * Subject with a current medication treatment (for the control group only), * Subject with a contraindication to the ingestion of a thermal capsule, namely: * Weight less than 37 kg * Inflammatory, motor or obstructive disease of the digestive tract * History of digestive surgery * Participant requiring a CT or MRI scan prior to removal of the thermal capsule (scheduled scan) * Presence of an implantable electronic device (e.g. pacemaker)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05847465 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heat Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05847465 currently recruiting?
Yes, NCT05847465 is actively recruiting participants. Contact the research team at alexandra.malgoyre@intradef.gouv.fr for enrollment information.
Where is the NCT05847465 trial being conducted?
This trial is being conducted at Brétigny-sur-Orge, France.
Who is sponsoring the NCT05847465 clinical trial?
NCT05847465 is sponsored by Direction Centrale du Service de Santé des Armées. The trial plans to enroll 50 participants.
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