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

January 1, 2025 updated by: ITAY, Medical Corps, Israel Defense Force

Cognitive Assessment During Heat Tolerance Test

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.

Study Overview

Status

Completed

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.

Study Type

Observational

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Israeli Defense Forces combat soldiers

Description

Inclusion Criteria:

  • Combat soldiers post exertional heat injury

Exclusion Criteria:

  • Additional medical condition restricting combat duty

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Combat soldiers post exertional heat injury
Participants were classified into heat-intolerant (HI) or heat-tolerant (HT) groups based on their HTT physiological outcomes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Classified as Heat-Intolerant during Heat Tolerant Test
Time Frame: 120 minutes
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.
120 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Daniel S Moran, PhD, Institute of Military Physiology, IDF Medical Corps, Tel Hashomer, Israel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2018

Primary Completion (Actual)

December 21, 2024

Study Completion (Actual)

December 21, 2024

Study Registration Dates

First Submitted

December 24, 2024

First Submitted That Met QC Criteria

January 1, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 1, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDF- 123 1779-2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Exertional Heat Injury

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