NCT06764264

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 24, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 8, 2025

Completed
Last Updated

January 8, 2025

Status Verified

January 1, 2025

Enrollment Period

6.9 years

First QC Date

December 24, 2024

Last Update Submit

January 1, 2025

Conditions

Keywords

Heat Tolerance TestExertional heat injuryCognitive ImpairmentThermoregulatory Function

Outcome Measures

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.

    120 minutes

Study Arms (1)

Combat soldiers post exertional heat injury

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

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Israeli Defense Forces combat soldiers

You may qualify if:

  • Combat soldiers post exertional heat injury

You may not qualify if:

  • Additional medical condition restricting combat duty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heller Institute, Institute of Military Physiology, IDF Medical Corps

Tel Litwinsky, Israel, Israel

Location

Related Publications (4)

  • 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.

    PMID: 9688970BACKGROUND
  • Epstein Y, Sohar E, Shapiro Y. Exertional heatstroke: a preventable condition. Isr J Med Sci. 1995 Jul;31(7):454-62.

    PMID: 7607879BACKGROUND
  • 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.

    PMID: 15173669BACKGROUND
  • 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.

    PMID: 17923727BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Daniel S Moran, PhD

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

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Sagi Shpitzer, MD, Chief Medical Officer, IDF Physiology Institute, Principal Investigator

Study Record Dates

First Submitted

December 24, 2024

First Posted

January 8, 2025

Study Start

February 1, 2018

Primary Completion

December 21, 2024

Study Completion

December 21, 2024

Last Updated

January 8, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, 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.

Locations