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CompletedNCT06764264Updated Jan 8, 2025

Integrating Cognitive Assessments Into the Heat Tolerance Test After Exertional Heat Injury

An observational study in Exertional Heat Injury, sponsored by Medical Corps, Israel Defense Force. Completed at 1 site in Israel. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-08.

Sponsored by Medical Corps, Israel Defense Force · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
70
Ages
18 Years and older
Sex
Male
01

Study summary

This prospective observational study is to evaluate soldiers post-exertional heat injury (EHI) during a heat tolerant test (HTT) to investigate the impact on their cognitive performance.

Read the detailed description

The objective of the proposed research is to add a cognitive evaluation to the physiological parameters monitored in the heat tolerance test (HTT) and to construct a new cognitive-physiological model for evaluation based on the accumulated knowledge on soldiers' heat tolerance. Each year, in the Israel Defense Forces (IDF), approximately 50 soldiers post exertional heat injury (EHI) are referred to perform the HTT. The HTT is carried out approximately one month post injury as part of clinical evaluation of the patient and is also intended to determine return to duty for combatants in field units. Currently, the criteria used in the HTT to determine heat tolerance are based solely on physiological parameters, while no cognitive evaluation is utilized in the HTT. Noteworthy are the numerous studies published in scientific literature describing the influence of exposure to heat conditions and physical effort on cognition and psychological strain in humans.

The subjects performing the HTT will also undergo cognitive evaluation and psychological strain assessment using tests used and validated in the research laboratories of the United States military (USARIEM). The cognitive evaluation will be performed in addition to the validated physiological monitoring performed in the HTT. All gathered physiological and cognitive data will be used to construct new bio-statistical models and new criteria will be suggested for the definition of heat tolerance or intolerance.

02

Conditions studied

  • Exertional Heat Injury

Keywords

  • Heat Tolerance Test
  • Exertional heat injury
  • Cognitive Impairment
  • Thermoregulatory Function
03

In context

Cognitive Dysfunction

3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.

This study's enrollment of 70 is below the median of 150 across 997 observational studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

Medical Corps, Israel Defense Force is the lead sponsor of 33 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Israeli Defense Forces combat soldiers

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Combat soldiers post exertional heat injury

Exclusion criteria

Exclusion Criteria:

  • Additional medical condition restricting combat duty
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
70 participants (actual)
Patient registry
No

Groups and cohorts

  • Combat soldiers post exertional heat injury

    Participants were classified into heat-intolerant (HI) or heat-tolerant (HT) groups based on their HTT physiological outcomes.

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What researchers measure

Primary outcomes

  1. Number of Participants Classified as Heat-Intolerant during Heat Tolerant Test

    Participants are classified as heat-intolerant if they exhibit any of the following indicators during the Heat Tolerance Test: a core body temperature (Tre) ≥ 38.5°C (≥ 101.38°F), a heart rate (HR) ≥ 150 bpm, or failure to achieve a Tre-to-HR ratio ≥ 0.2798°C ∙ bpm-¹. Participants meeting none of these criteria are classified as heat-tolerant.

    Time frame: 120 minutes

07

Study locations

1 site
  • Heller Institute, Institute of Military Physiology, IDF Medical Corps
    Tel Hashomer, Israel
08

References and documents

Publications

  • Moran DS, Shitzer A, Pandolf KB. A physiological strain index to evaluate heat stress. Am J Physiol. 1998 Jul;275(1):R129-34. doi: 10.1152/ajpregu.1998.275.1.R129. PubMed 9688970 ↗
  • Epstein Y, Sohar E, Shapiro Y. Exertional heatstroke: a preventable condition. Isr J Med Sci. 1995 Jul;31(7):454-62. PubMed 7607879 ↗
  • Moran DS, Heled Y, Still L, Laor A, Shapiro Y. Assessment of heat tolerance for post exertional heat stroke individuals. Med Sci Monit. 2004 Jun;10(6):CR252-7. Epub 2004 Jun 1. PubMed 15173669 ↗
  • Moran DS, Erlich T, Epstein Y. The heat tolerance test: an efficient screening tool for evaluating susceptibility to heat. J Sport Rehabil. 2007 Aug;16(3):215-21. doi: 10.1123/jsr.16.3.215. PubMed 17923727 ↗

Individual participant data

Plan to share: Yes — The data for this belong to the Israel Defense Forces and the Israel Ministry of Defense. Data sharing will be considered if the corresponding author receives a reasonable request and establishes an institution-to-institution data-sharing agreement.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: The data are available, and sharing will be considered if the corresponding author receives a reasonable request and establishes an institution-to-institution data-sharing agreement.

Access criteria: Sharing will be considered if the corresponding author receives a reasonable request and establishes an institution-to-institution data-sharing agreement.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06764264
Lead sponsor
Medical Corps, Israel Defense Force
Collaborators
The Chaim Sheba Medical Center
Responsible party
ITAY (Dr. Sagi Shpitzer, MD, Chief Medical Officer, IDF Physiology Institute, Principal Investigator, Medical Corps, Israel Defense Force) — Principal investigator
First posted
Jan 8, 2025
Start date
Feb 1, 2018
Primary completion
Dec 21, 2024
Completion
Dec 21, 2024
Last update
Jan 8, 2025

Study contacts

Daniel S Moran, PhD
study director · Institute of Military Physiology, IDF Medical Corps, Tel Hashomer, Israel

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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