Risk Factors for Exertional Heat Illness

Exertional Heat Illness Clinical Trial

Official title:

Prospective Investigation of Risk Factors for Exertional Heat Illness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04979455
• Other study ID #: 2029/MODREC/21
• Status: Recruiting
• Start date: June 11, 2021
• Est. completion date: October 2024

Study information

• Verified date: September 2023
• Source: Liverpool John Moores University
• Contact: Michael J Zurawlew, PhD
• Phone: 07875476915
• Email: m.j.zurawlew[@]ljmu.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 783
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 35 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Self-report as pregnant

Related Conditions & MeSH terms

• Exertional Heat Illness
• Heat Stress Disorders

Intervention

Other:
• Core temperature monitoring
Core temperature will be monitored on the day of exercise

Behavioral:
• Questionnaires
Questionnaires will be completed at baseline and on the day of exercise

Other:
• Heart rate monitoring
Heart rate will be monitored on the day of exercise
• Urine collection
Urine samples will be collected at baseline and on the day of exercise
• Sleep monitoring
Sleep will be monitored at baseline and on the day of exercise
• Blood collection
Blood samples will be completed at baseline
• Saliva collection
Saliva samples will be collected at baseline and on the day of exercise
• Throat swab collection
Throat swab samples will be collected at baseline and on the day of exercise
• Stool collection
Stool samples will be collected at baseline and on the day of exercise

Locations

Country	Name	City	State
United Kingdom	Commando Training Centre Royal Marine	Lympstone	Devon

Sponsors (8)

Lead Sponsor	Collaborator
Liverpool John Moores University	Bangor University (UK), CTCRM Lympstone (UK), Defence Science and Technology (UK), Headquarters Army Recruiting and Initial Training Command (UK), Institute of Naval Medicine (UK), Public Health Wales (UK), University of Portsmouth (UK)

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body mass index in EHI and control group		Baseline
Primary	Fitness in EHI and control group - participants ranked by time to complete fitness test		Baseline
Primary	Core temperature in EHI and control group		1 Day
Primary	Heart rate in EHI and control group		2 Hours
Primary	Urine osmolality in EHI and control group		Baseline
Primary	Sleep quality and quantity, measured by Pittsburgh Sleep Quality Index, in EHI and control group	0-21 Scale. Higher score indicates worse outcome	Throughout study - up to 1 week
Primary	Sleep quality, measured by actigraphy, between EHI and control group		Throughout study - up to 1 week
Primary	Sleep quantity, measured by actigraphy, between EHI and control group		Throughout study - up to 1 week
Primary	Circulating Interleukin 6 in EHI and control group		Baseline
Primary	Circulating C-Reactive Protein in EHI and control group		Baseline
Primary	Circulating Creatine kinase in EHI and control group		Baseline
Primary	Circulating Aspartate Aminotransferase in EHI and control group		Baseline
Primary	Circulating Alanine Aminotransferase in EHI and control group		Baseline
Primary	Circulating Claudin 3 in EHI and control group		Baseline
Primary	Circulating Zonulin in EHI and control group		Baseline
Primary	Circulating Lipopolysaccharide binding protein in EHI and control group		Baseline
Primary	Circulating immunoglobulin E in EHI and control group		Baseline
Primary	Salivary cortisol in EHI and control group		Throughout study - up to 1 week
Primary	Detection of infectious pathogens in EHI and control groups		Throughout study - up to 1 week
Primary	Respiratory illness symptomology, measured by Jackson common cold questionnaire, in EHI and control group	0-24 Scale. Higher score indicates worse outcome	Throughout study - up to 1 week
Primary	Gastrointestinal illness symptomology, measured by gastrointestinal symptoms questionnaire, in EHI and control group	0-10 Scale per symptom. Higher score indicates worse outcome	Throughout study - up to 1 week
Primary	Abundance and diversity of gastrointestinal microbiota in EHI and control group		Baseline