Heat StressPENTHERENCT05921864
Study of Biomarkers of Heat Tolerance and Recovery During Ultra-endurance Exercise
An observational study of Heat Stress and Heat, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
Trial summary
Military personnel are called upon to serve in hot, dry or humid climates, which places great demands on their ability to tolerate heat. Induced heat stress can impair performance and lead to pathologies. Read more about this study
- Who is it for?
- Ages 18 to 37 yearsHealthy volunteers can take part
- Conditions the study is for
- Heat Stress, Heat
- What is being tested?
- Passive heat exposure and Active heat exposure
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jun 2023to 22 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 37 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study population will be composed of healthy young athletes.
Who may be able to join
- Healthy individuals
- BMI between 18 and 25 kg/m2
- Weight ≥ 51 kg
- Minimum training volume 6 days/7, aerobic
- Participation in a running competition ≥ 6hours
- Having given informed consent
Who cannot join
- Presence or history of medical pathology
- Presence of significant deviation from normal electrocardiogram values
- History of heat stroke
- Known intolerance to heat
- Inability to swallow a capsule or refusal of rectal probe
- Alcohol consumption exceeding the equivalent of 3 glasses of wine per week
Show all 11Show fewer
- Consumption of narcotics
- Smoking > 0.5 pack of cigarettes per day
- On usual medication
- Pregnant or breast-feeding women
- Protected adult, under legal protection, guardianship or curatorship, or unable to give personal written consent
Trial locations and contacts
1 site in 1 country.
France1 site
Institut de Recherche Biomédicale des Armées
Brétigny-sur-Orge, 91223
About this study
Military personnel are called upon to serve in hot, dry or humid climates, which places great demands on their ability to tolerate heat. Induced heat stress can impair performance and lead to pathologies. Faced with the challenges of global warming, this issue is becoming increasingly important in the practice of sport. While hyperthermia is known to impair endurance performance, the underlying thermophysiological responses and regulatory mechanisms during prolonged exercise remain poorly understood. The effects of hyperthermia on mental performance raise questions about the degradation of interoceptive capacities and the deleterious impact on behavioral regulation, an important component of thermal risk management in ultra-endurance exercise. What's more, despite the muscular and hydromineral consequences (rhabdomyolysis, renal failure, dehydration) of prolonged exercise, few data are available on recovery kinetics. A better understanding of the factors conditioning recovery quality could help limit the deleterious consequences of ultra-endurance exercise.
- Conditions
- Heat Stress, Heat
- Being tested
- Passive heat exposure, Active heat exposure
- Keywords
- ultra-endurance
- Medical subject headings
- Heat Stress Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive heat exposureOther
Participants will be exposed to heat in a chamber.
Active heat exposureOther
Participants will participate to a 6-hour run.
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of correlation between core temperature measured at the end of passive heat exposure and that measured at the end of active heat exposure
Core temperature will be measured in every participants at the end of passive heat exposure and at the end of active heat exposure. A correlation analysis will be performed on these measurements.
Measured: Through study completion (1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start19 Jun 2023
- Primary completion22 Jul 2023
- Study completion22 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heat StressStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
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
- NCT05921864
- Sponsor's protocol ID
- 2023PBMD05
- Other IDs
- 2023-A00730-45
- Acronym
- PENTHERE
- Status last verified
- Sep 2023
- First submitted
- 16 Jun 2023
- Last updated
- 8 Sep 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 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Biomarkers of Heat Tolerance and Recovery During Ultra-endurance Exercise
- ClinicalTrials.gov ID
- NCT05921864
- Acronym / sponsor ID
- PENTHERE / 2023PBMD05
- Conditions
- Heat Stress, Heat
- Keywords
- ultra-endurance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- 22 Jul 2023 (actual)
- Study completion
- 22 Jul 2023 (actual)
- First posted
- 27 Jun 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.
Military personnel are called upon to serve in hot, dry or humid climates, which places great demands on their ability to tolerate heat. Induced heat stress can impair performance and lead to pathologies. Faced with the challenges of global warming, this issue is becoming increasingly important in the practice of sport. While hyperthermia is known to impair endurance performance, the underlying thermophysiological responses and regulatory mechanisms during prolonged exercise remain poorly understood. The effects of hyperthermia on mental performance raise questions about the degradation of interoceptive capacities and the deleterious impact on behavioral regulation, an important component of thermal risk management in ultra-endurance exercise. What's more, despite the muscular and hydromineral consequences (rhabdomyolysis, renal failure, dehydration) of prolonged exercise, few data are available on recovery kinetics. A better understanding of the factors conditioning recovery quality could help limit the deleterious consequences of ultra-endurance exercise.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 37 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population will be composed of healthy young athletes.
Key inclusion criteria (6 listed)
- Healthy individuals
- BMI between 18 and 25 kg/m2
- Weight ≥ 51 kg
- Minimum training volume 6 days/7, aerobic
- Participation in a running competition ≥ 6hours
Key exclusion criteria (11 listed)
- Presence or history of medical pathology
- Presence of significant deviation from normal electrocardiogram values
- History of heat stroke
- Known intolerance to heat
- Inability to swallow a capsule or refusal of rectal probe
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 |
|---|---|---|
| Passive heat exposureParticipants will be exposed to heat in a chamber. | Other | – |
| Active heat exposureParticipants will participate to a 6-hour run. | Other | – |
Primary outcome
Degree of correlation between core temperature measured at the end of passive heat exposure and that measured at the end of active heat exposure
Time frame: Through study completion (1 month)
Core temperature will be measured in every participants at the end of passive heat exposure and at the end of active heat exposure. A correlation analysis will be performed on these measurements.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Stress and Heat, 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 6 inclusion and 11 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: finished, as of the sponsor's last update on 8 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of correlation between core temperature measured at the end of passive heat exposure and that measured at the end of active heat exposure (time frame: Through study completion (1 month)). 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 8 Sep 2023.