Study of Risk Factors for the Occurrence and Severity of Exertional Heatstroke in the Military Environment
NCT ID: NCT04593316
Last Updated: 2021-03-09
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
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UNKNOWN
300 participants
OBSERVATIONAL
2020-11-02
2024-11-30
Brief Summary
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Extrinsic factors are well known (high ambient temperature and hygrometry, poorly "breathable" clothing, intense and prolonged physical effort) but some of them may be observed in milder conditions. In the French Armed Forces, 25% of the exertional heatstrokes that have been reported between 2005 and 2011 occurred below 17°C.
Intrinsic factors, on the other hand, are numerous and less consensual, partly because of the imperfect knowledge of exertional heatstroke physiopathology. Potential factors include a thermoregulatory defect (inability to maintain a temperature plateau during an effort) and several genetic mutations may also contribute to explain a propensity to present an exertional heatstroke. While exertional heatstroke is clearly not a monogenic pathology, the association of several polymorphisms could contribute to this vulnerability. Among the genes that have been explored, mutations in ryanodine receptor type 1 (RyR 1), calsequestrin-1 or angiotensin-1 converting enzyme (ACE) appear to be potential candidates. However, it is very likely that other polymorphisms may be involved, such as: genes involved in sports performance and exercise rhabdomyolysis, in the inflammatory cascade, permeability of the digestive epithelial barrier, adenosine receptors and susceptibility to anxiety.
Finally, motivation is a mixed factor often claimed to be involved in exertional heatstroke but has never been quantified and needs to be objectified.
To date, none of these hypotheses has been clearly assessed by comparing patients who experienced exertional heatstroke to healthy subjects.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Exertional heatstroke group
Patients presenting or having presented exertional heatstroke.
Saliva collection
A saliva sample will be collected before physical exercise.
Questionnaires
The participant will fill in questionnaires relative to his heath status and psychological and motivational resource questionnaires before physical exercise.
Ingestible core temperature capsule intake
The participant will ingest a capsule before physical exercise in order to continuously monitor core temperature during physical exercise.
Physical exercise
The participant will perform a walk/run test.
Heart rate monitoring
Heart rate will be monitored during physical exercise thanks to a chest belt.
Core temperature monitoring
Heart rate will be monitored during physical exercise thanks to an ingestible core temperature capsule.
Control group
Healthy people who never experienced exertional heatstroke.
Saliva collection
A saliva sample will be collected before physical exercise.
Questionnaires
The participant will fill in questionnaires relative to his heath status and psychological and motivational resource questionnaires before physical exercise.
Ingestible core temperature capsule intake
The participant will ingest a capsule before physical exercise in order to continuously monitor core temperature during physical exercise.
Physical exercise
The participant will perform a walk/run test.
Heart rate monitoring
Heart rate will be monitored during physical exercise thanks to a chest belt.
Core temperature monitoring
Heart rate will be monitored during physical exercise thanks to an ingestible core temperature capsule.
Interventions
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Saliva collection
A saliva sample will be collected before physical exercise.
Questionnaires
The participant will fill in questionnaires relative to his heath status and psychological and motivational resource questionnaires before physical exercise.
Ingestible core temperature capsule intake
The participant will ingest a capsule before physical exercise in order to continuously monitor core temperature during physical exercise.
Physical exercise
The participant will perform a walk/run test.
Heart rate monitoring
Heart rate will be monitored during physical exercise thanks to a chest belt.
Core temperature monitoring
Heart rate will be monitored during physical exercise thanks to an ingestible core temperature capsule.
Eligibility Criteria
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Inclusion Criteria
* Between 18 and 45 years old
* Ability to the walk/run test
Exclusion Criteria
* BMI greater than or equal to 30,
* Contraindication to the ingestion of a core temperature capsule
18 Years
45 Years
ALL
Yes
Sponsors
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Direction Centrale du Service de Santé des Armées
OTHER
Responsible Party
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Locations
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Institut de Recherche Biomédicale des Armées
Brétigny-sur-Orge, , France
Hôpital d'Instruction des Armées Laveran
Marseille, , France
Ecole du Val-de-Grâce
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2020-A01967-32
Identifier Type: OTHER
Identifier Source: secondary_id
2019PBMD03
Identifier Type: -
Identifier Source: org_study_id
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