Clinical trial NCT04979455: Risk Factors for Exertional Heat Illness
Official title: Prospective Investigation of Risk Factors for Exertional Heat Illness
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Exertional Heat Illness
Lead sponsor: Liverpool John Moores University
Sponsor class: OTHER
Collaborators: name: Institute of Naval Medicine (UK)
name: CTCRM Lympstone (UK)
name: University of Portsmouth (UK)
name: Public Health Wales
name: Bangor University (UK)
name: Headquarters Army Recruiting and Initial Training Command (UK)
name: Defence Science and Technology (UK)
First posted: 2021-07-28
Enrollment: 783
Sex: ALL
Minimum age (years): 17
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who experience and participants who do not experience an atypical elevation in thermal strain or an EHI undergoing strenuous physical exercise.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Self-report as pregnant

Primary outcomes:
measure: Body mass index in EHI and control group
timeFrame: Baseline
measure: Fitness in EHI and control group - participants ranked by time to complete fitness test
timeFrame: Baseline
measure: Core temperature in EHI and control group
timeFrame: 1 Day
measure: Heart rate in EHI and control group
timeFrame: 2 Hours
measure: Urine osmolality in EHI and control group
timeFrame: Baseline
measure: Sleep quality and quantity, measured by Pittsburgh Sleep Quality Index, in EHI and control group
timeFrame: Throughout study - up to 1 week
measure: Sleep quality, measured by actigraphy, between EHI and control group
timeFrame: Throughout study - up to 1 week
measure: Sleep quantity, measured by actigraphy, between EHI and control group
timeFrame: Throughout study - up to 1 week
measure: Circulating Interleukin 6 in EHI and control group
timeFrame: Baseline
measure: Circulating C-Reactive Protein in EHI and control group
timeFrame: Baseline
measure: Circulating Creatine kinase in EHI and control group
timeFrame: Baseline
measure: Circulating Aspartate Aminotransferase in EHI and control group
timeFrame: Baseline
measure: Circulating Alanine Aminotransferase in EHI and control group
timeFrame: Baseline
measure: Circulating Claudin 3 in EHI and control group
timeFrame: Baseline
measure: Circulating Zonulin in EHI and control group
timeFrame: Baseline
measure: Circulating Lipopolysaccharide binding protein in EHI and control group
timeFrame: Baseline
measure: Circulating immunoglobulin E in EHI and control group
timeFrame: Baseline
measure: Salivary cortisol in EHI and control group
timeFrame: Throughout study - up to 1 week
measure: Detection of infectious pathogens in EHI and control groups
timeFrame: Throughout study - up to 1 week
measure: Respiratory illness symptomology, measured by Jackson common cold questionnaire, in EHI and control group
timeFrame: Throughout study - up to 1 week
measure: Gastrointestinal illness symptomology, measured by gastrointestinal symptoms questionnaire, in EHI and control group
timeFrame: Throughout study - up to 1 week
measure: Abundance and diversity of gastrointestinal microbiota in EHI and control group
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Lympstone
country: United Kingdom
facility: Commando Training Centre Royal Marine
state: Devon
Study officials:
References: