Clinical trial NCT06764264: Integrating Cognitive Assessments Into the Heat Tolerance Test After Exertional Heat Injury
Official title: Cognitive Assessment During Heat Tolerance Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exertional Heat Injury
Keywords: Heat Tolerance Test
Exertional heat injury
Cognitive Impairment
Thermoregulatory Function
Lead sponsor: Medical Corps, Israel Defense Force
Sponsor class: OTHER
Collaborators: name: The Chaim Sheba Medical Center
First posted: 2025-01-08
Enrollment: 70
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Israeli Defense Forces combat soldiers

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Combat soldiers post exertional heat injury

Exclusion Criteria:

* Additional medical condition restricting combat duty

Primary outcomes:
measure: Number of Participants Classified as Heat-Intolerant during Heat Tolerant Test
timeFrame: 120 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Heller Institute, Institute of Military Physiology, IDF Medical Corps
Study officials:
affiliation: Institute of Military Physiology, IDF Medical Corps, Tel Hashomer, Israel
name: Daniel S Moran, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Epstein Y, Sohar E, Shapiro Y. Exertional heatstroke: a preventable condition. Isr J Med Sci. 1995 Jul;31(7):454-62.
citation: 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.
citation: 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.