Actively Recruiting
Study of Thermoregulation in Exercise Heat Stroke in the Military Environment
Led by Direction Centrale du Service de Santé des Armées · Updated on 2023-08-02
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
The EXPLO-MITO study focuses on people affected by exercise heat stroke and healthy individuals, studying how their bodies regulate heat during physical activity. This observational study uses the Heat Tolerance Test (HTT), which is a controlled treadmill walk in a hot environment to measure how well participants tolerate heat. The test aims to distinguish between those who are heat intolerant and heat tolerant by monitoring heart rate, body temperatures, skin blood flow, and sweat loss. Participants undergo several tests including the HTT, a bike stress test involving cycling with gas exchange monitoring, and a heat nociception test using infrared light to assess heat sensitivity. The HTT specifically involves walking at 5 km/h on a 2% slope in a 40°C environment with 40% humidity while continuously measuring rectal temperature, heart rate, and skin temperature, and checking blood pressure every 30 minutes. The study includes a case group of heat stroke patients and a control group of healthy individuals. During the study, participants will be monitored closely with physiological measurements and tests to understand their heat regulation. Researchers will measure the percentage of heat intolerant individuals throughout the 48-month study period. The tests are designed to be safe and reproducible under controlled laboratory conditions. Participants' exercise habits and medical history are also considered to assess their heat tolerance and recovery after heat stroke.
CONDITIONS
Brief Title
Study of Thermoregulation in Exercise Heat Stroke in the Military Environment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be included in the main EXPLO-CCE study
- Participate in at least two aerobic exercise sessions per week
- At least two months have passed since the exercise heat stroke event
You will not qualify if you...
- Current medication treatment (for control group participants only)
- Weight less than 37 kg
- Inflammatory, motor, or obstructive disease of the digestive tract
- History of digestive surgery
- Requirement for CT or MRI scan before removal of thermal capsule
- Presence of an implantable electronic device such as a pacemaker
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to study completion (48 months)
Participants undergo tests including a bike stress test, heat tolerance test, and heat nociception test to assess their thermoregulation and heat intolerance.
1 to 2 visits depending on group assignment
Duration - Through study completion (48 months)
Participants are monitored over time to evaluate the percentage of heat intolerant individuals based on the Heat Tolerance Test.
Periodic assessments during the study period
Trial Site Locations
Total: 1 location
1
Institut de Recherche Biomédicale des Armées
Brétigny-sur-Orge, France, 91223
Actively Recruiting
Research Team
A
Alexandra MALGOYRE, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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