Heat StrokeEXPLO-MITONCT05847465
Study of Thermoregulation in Exercise Heat Stroke in the Military Environment
An observational study of Heat Stroke, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heat Stroke
- What is being tested?
- Bike stress test, Heat Tolerance Test and Heat nociception test
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 9 May 2023to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This ancillary study will involve a subgroup of participants included in the case group (exercise heat stroke) and the control group of the main EXPLO-CCE study.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Institut de Recherche Biomédicale des Armées
Brétigny-sur-Orge, 91223
Alexandra MALGOYRE, MD, PhD, 178651317 ext. +33, alexandra.malgoyre@intradef.gouv.fr
About this study
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.
Read more
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.
- Conditions
- Heat Stroke
- Being tested
- Bike stress test, Heat Tolerance Test, Heat nociception test
- Keywords
- Heat tolerance test
- Medical subject headings
- Heat Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bike stress testOther
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 TestOther
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 testOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Bike stress test; Other: Heat Tolerance Test; Other: Heat nociception test | |
| Control group (healthy individuals) | Participants enrolled in the control group are healthy individuals who are participating in the main EXPLO-CCE study. Receives: Other: Bike stress test; Other: Heat Tolerance Test; Other: Heat nociception test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of heat intolerant individuals based on the Heat Tolerance Test
Classification of participants between Heat Intolerant (HI) and Heat Tolerant (HT) will be determined according to measured rectal temperature.
Participants will be classified as HI if they have at least one of the following criteria at HTT:
- Rectal temperature > 38.5°C at the end of the 2 hours
- Rectal temperature change during the second hour > 0.45°C
Measured: Through study completion (48 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start9 May 2023
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heat StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847465
- Sponsor's protocol ID
- 2019PBMD03-1
- Other IDs
- 2023-A00156-39
- Acronym
- EXPLO-MITO
- Status last verified
- Aug 2023
- First submitted
- 27 Apr 2023
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Thermoregulation in Exercise Heat Stroke in the Military Environment
- ClinicalTrials.gov ID
- NCT05847465
- Acronym / sponsor ID
- EXPLO-MITO / 2019PBMD03-1
- Conditions
- Heat Stroke
- Keywords
- Heat tolerance test
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 9 May 2023 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group (exercise heat stroke patients) | – | Other: Bike stress test, Other: Heat Tolerance Test, Other: Heat nociception testParticipants enrolled in the case group have been experiencing exercise heat stroke and are participating in the main EXPLO-CCE study. |
| Control group (healthy individuals) | – | Other: Bike stress test, Other: Heat Tolerance Test, Other: Heat nociception testParticipants enrolled in the control group are healthy individuals who are participating in the main EXPLO-CCE study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This ancillary study will involve a subgroup of participants included in the case group (exercise heat stroke) and the control group of the main EXPLO-CCE study.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- Subject with a current medication treatment (for the control group only),
- Subject with a contraindication to the ingestion of a thermal capsule, namely:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bike stress testThis 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®). | Other | Case group (exercise heat stroke patients), Control group (healthy individuals) |
| Heat Tolerance TestThe 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. | Other | Case group (exercise heat stroke patients), Control group (healthy individuals) |
| Heat nociception testThis 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. | Other | Case group (exercise heat stroke patients), Control group (healthy individuals) |
Primary outcome
Percentage of heat intolerant individuals based on the Heat Tolerance Test
Time frame: Through study completion (48 months)
Classification of participants between Heat Intolerant (HI) and Heat Tolerant (HT) will be determined according to measured rectal temperature. Participants will be classified as HI if they have at least one of the following criteria at HTT: * Rectal temperature > 38.5°C at the end of the 2 hours * Rectal temperature change during the second hour > 0.45°C
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heat Stroke, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandra MALGOYRE, MD, PhD (178651317 ext. +33, alexandra.malgoyre@intradef.gouv.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of heat intolerant individuals based on the Heat Tolerance Test (time frame: Through study completion (48 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.