Study of Thermoregulation in Exercise Heat Stroke in the Military Environment
NCT ID: NCT05847465
Last Updated: 2023-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
50 participants
OBSERVATIONAL
2023-05-09
2027-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Risk Factors for the Occurrence and Severity of Exertional Heatstroke in the Military Environment
NCT04593316
Study of Biomarkers of Heat Tolerance and Recovery During Ultra-endurance Exercise
NCT05921864
Comparing Exertional Heat Illness Risk Factors Between Patients and Controls
NCT05303142
Risk Factors for Exertional Heat Illness
NCT04979455
Integrating Cognitive Assessments Into the Heat Tolerance Test After Exertional Heat Injury
NCT06764264
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Case group (exercise heat stroke patients)
Participants enrolled in the case group have been experiencing exercise heat stroke and are participating in the main EXPLO-CCE study.
Bike stress test
This is an incremental exercise under maximal pedaling on an Excalibur® type bike with electromagnetic brake over 36 minutes during which gas exchanges are continuously measured through a face mask (Cosmed®).
Heat Tolerance Test
The test consists of a walk on a treadmill in shorts, bare chest or bra for women, at 5 km/h and 2% slope in an environment at 40°C, 40% relative humidity, without convection.
During the test, rectal temperature, heart rate and skin temperature will be monitored continuously.
The blood pressure will be measured manually every 30 minutes during the test.
Heat nociception test
This test consists in applying a thermal flux generated by an infrared light source on a beam of 1 cm diameter on 2 areas of the dominant lower limb (glabrous face of the forearm and thenar eminence).
Participants will be instructed to remove their limb as soon as the sensation of heat begins to become uncomfortable.
The time between the beginning of the stimulus and the moment of withdrawal will be recorded.
Control group (healthy individuals)
Participants enrolled in the control group are healthy individuals who are participating in the main EXPLO-CCE study.
Bike stress test
This is an incremental exercise under maximal pedaling on an Excalibur® type bike with electromagnetic brake over 36 minutes during which gas exchanges are continuously measured through a face mask (Cosmed®).
Heat Tolerance Test
The test consists of a walk on a treadmill in shorts, bare chest or bra for women, at 5 km/h and 2% slope in an environment at 40°C, 40% relative humidity, without convection.
During the test, rectal temperature, heart rate and skin temperature will be monitored continuously.
The blood pressure will be measured manually every 30 minutes during the test.
Heat nociception test
This test consists in applying a thermal flux generated by an infrared light source on a beam of 1 cm diameter on 2 areas of the dominant lower limb (glabrous face of the forearm and thenar eminence).
Participants will be instructed to remove their limb as soon as the sensation of heat begins to become uncomfortable.
The time between the beginning of the stimulus and the moment of withdrawal will be recorded.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bike stress test
This is an incremental exercise under maximal pedaling on an Excalibur® type bike with electromagnetic brake over 36 minutes during which gas exchanges are continuously measured through a face mask (Cosmed®).
Heat Tolerance Test
The test consists of a walk on a treadmill in shorts, bare chest or bra for women, at 5 km/h and 2% slope in an environment at 40°C, 40% relative humidity, without convection.
During the test, rectal temperature, heart rate and skin temperature will be monitored continuously.
The blood pressure will be measured manually every 30 minutes during the test.
Heat nociception test
This test consists in applying a thermal flux generated by an infrared light source on a beam of 1 cm diameter on 2 areas of the dominant lower limb (glabrous face of the forearm and thenar eminence).
Participants will be instructed to remove their limb as soon as the sensation of heat begins to become uncomfortable.
The time between the beginning of the stimulus and the moment of withdrawal will be recorded.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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)
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Direction Centrale du Service de Santé des Armées
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Institut de Recherche Biomédicale des Armées
Brétigny-sur-Orge, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-A00156-39
Identifier Type: OTHER
Identifier Source: secondary_id
2019PBMD03-1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.