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Clinical Trials/NCT04979455
NCT04979455
Active, not recruiting
Not Applicable

Prospective Investigation of Risk Factors for Exertional Heat Illness

Liverpool John Moores University1 site in 1 country783 target enrollmentJune 11, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Exertional Heat Illness
Sponsor
Liverpool John Moores University
Enrollment
783
Locations
1
Primary Endpoint
Heart rate in EHI and control group
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

The arduous nature of military training and operations require personnel to encounter high heat load, e.g., during intense physical exertion, particularly in the heat. These conditions reduce operational effectiveness and expose personnel to a risk of incapacitation and death from exertional heat illness (EHI).

The aim of this study is to examine traditional and novel risk factors that may increase thermal strain and EHI likelihood in military recruits undergoing strenuous physical exercise.

Registry
clinicaltrials.gov
Start Date
June 11, 2021
End Date
July 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Men and women aged 17-35 years enrolled in military training

Exclusion Criteria

  • Self-report as pregnant

Outcomes

Primary Outcomes

Heart rate in EHI and control group

Time Frame: 2 Hours

Sleep quality, measured by actigraphy, between EHI and control group

Time Frame: Throughout study - up to 1 week

Circulating C-Reactive Protein in EHI and control group

Time Frame: Baseline

Circulating Aspartate Aminotransferase in EHI and control group

Time Frame: Baseline

Circulating Claudin 3 in EHI and control group

Time Frame: Baseline

Gastrointestinal illness symptomology, measured by gastrointestinal symptoms questionnaire, in EHI and control group

Time Frame: Throughout study - up to 1 week

0-10 Scale per symptom. Higher score indicates worse outcome

Urine osmolality in EHI and control group

Time Frame: Baseline

Circulating Creatine kinase in EHI and control group

Time Frame: Baseline

Circulating Lipopolysaccharide binding protein in EHI and control group

Time Frame: Baseline

Salivary cortisol in EHI and control group

Time Frame: Throughout study - up to 1 week

Abundance and diversity of gastrointestinal microbiota in EHI and control group

Time Frame: Baseline

Core temperature in EHI and control group

Time Frame: 1 Day

Sleep quantity, measured by actigraphy, between EHI and control group

Time Frame: Throughout study - up to 1 week

Circulating Interleukin 6 in EHI and control group

Time Frame: Baseline

Detection of infectious pathogens in EHI and control groups

Time Frame: Throughout study - up to 1 week

Respiratory illness symptomology, measured by Jackson common cold questionnaire, in EHI and control group

Time Frame: Throughout study - up to 1 week

0-24 Scale. Higher score indicates worse outcome

Body mass index in EHI and control group

Time Frame: Baseline

Fitness in EHI and control group - participants ranked by time to complete fitness test

Time Frame: Baseline

Circulating Zonulin in EHI and control group

Time Frame: Baseline

Circulating immunoglobulin E in EHI and control group

Time Frame: Baseline

Sleep quality and quantity, measured by Pittsburgh Sleep Quality Index, in EHI and control group

Time Frame: Throughout study - up to 1 week

0-21 Scale. Higher score indicates worse outcome

Circulating Alanine Aminotransferase in EHI and control group

Time Frame: Baseline

Study Sites (1)

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