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Comparing Exertional Heat Illness Risk Factors Between Patients and Controls

Comparison of Novel Putative Risk Factors for Exertional Heat Illness Between a Military Patient Cohort and Matched Control Cohort During Exercise Heat Stress

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05303142
Enrollment
95
Registered
2022-03-31
Start date
2022-02-01
Completion date
2023-03-06
Last updated
2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exertional Heat Illness

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 primary aim of this study is to compare putative 'chronic' EHI risk factors between a cohort who have suffered a history of EHI and a control cohort with no EHI history. The secondary aim is to examine the influence of these EHI risk factors on thermoregulation during a standard heat tolerance assessment.

Detailed description

Military training and operations present a risk of incapacitation and death from Exertional Heat Illness (EHI). However, widely accepted EHI risk factors are absent in almost half of all United Kingdom (UK) military EHI cases, indicating that a significant number of EHI cases in military personnel involve alternative risk factors. Risk factors for EHI can been classified along a spectrum ranging from acute (e.g. recent poor sleep) to chronic (e.g. low fitness), with the role of chronic risk factors supported by the observation that individuals who have suffered an EHI are at a substantially increased risk of subsequent EHI. The primary aim of this study is to compare putative 'chronic' EHI risk factors (e.g. composition of gastrointestinal (GI) microbiome, infection and inflammation, trait-like psychological factors) between a cohort who have suffered a history of EHI and a control cohort with no EHI history. The secondary aim is to examine the influence of these EHI risk factors on thermoregulation during a standard heat tolerance assessment.

Interventions

OTHERHeat Tolerance Assessment

60-90 minutes exercise in hot (34 °C; 45% R.H.) conditions at 60%VO2max

Sponsors

Liverpool John Moores University
CollaboratorOTHER
Institute of Naval Medicine (UK)
CollaboratorUNKNOWN
Headquarters Army Recruiting and Initial Training Command (UK)
CollaboratorUNKNOWN
Public Health Wales
CollaboratorOTHER_GOV
University of Portsmouth
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

Individuals with a history of EHI: * Previous EHI episode * Normal resting ECG * Male or female * 18 - 40 years Control participants: * No previous history of EHI * Normal resting ECG * Male or female * 18 - 40 years

Design outcomes

Primary

MeasureTime frameDescription
Resilience, measured by the Connor-Davidson resilience scaleBaseline -3 days
Core temperatureAt 60 minutes (or test termination if earlier) of Heat Tolerance AssessmentMeasured using a rectal thermistor.
Stress, measured by perceived stress scaleBaseline -3 days
Diversity of gastrointestinal microbiotaBaselineMeasured in stool sample. Assessed by alpha diversity score.
Abundance of gastrointestinal microbiotaBaselineMeasured in stool sample. Assessed at level of phylum.
Mental readinessBaselineVisual analogue scale (0-100). Higher scores indicate a lower state of mental readiness.
Detection of sexually transmitted pathogensBaselineAssessed from urine sample. Measured using cobas CT/NG assays.
Detection of respiratory pathogensBaselineAssessed from throat swab. Measured using Allplex assays.
Detection of gastrointestinal pathogensBaselineAssessed from stool swab. Measured using Allplex.
Circulating Interleukin 6BaselineMeasured using ELISA
Circulating C-Reactive ProteinBaselineMeasured using ELISA
Circulating Claudin 3BaselineMeasured using ELISA
Circulating ZonulinBaselineMeasured using ELISA
Circulating lipopolysaccharide binding proteinBaselineMeasured using ELISA
Circulating intestinal fatty acid binding proteinBaselineMeasured using ELISA
Gastrointestinal illness symptomology questionnaireBaselineVisual analogue scale (0-10). Higher scores indicate worse symptomology
Respiratory illness symptomology, measured by Jackson common cold questionnaireBaselineHigher scores indicate worse symptomology
Sleep quality and quantity, measured by Pittsburgh Sleep Quality IndexBaseline -3 daysHigher scores indicate worse sleep
Motivation, measured by Motivation scaleBaseline -3 days
State-trait anxiety, measured by state-trait anxiety inventory form Y-2Baseline -3 days
Risk taking, measured by the risk-taking inventoryBaseline -3 days
StressBaselineVisual analogue scale (0-100). Higher scores indicate a greater state of stress.

Secondary

MeasureTime frameDescription
Sweat rateDuring Heat Tolerance AssessmentDetermined from change in nude body mass during the heat tolerance assessment
Skin TemperatureDuring Heat Tolerance AssessmentWeighted mean skin temperature
Heat rateAt 5 minute intervals during the Heat Tolerance Assessment
Thermal comfortAt 15 minute intervals during Heat Tolerance AssessmentModified 9 point Gagge scale. Higher scores indicate worse comfort.
Thermal sensationAt 15 minute intervals during Heat Tolerance AssessmentModified 9 point Gagge scale. Higher scores indicate hotter sensation
Rating of Perceived ExertionAt 15 minute intervals during Heat Tolerance Assessment6-20 Borg scale. Higher scores indicate higher perceived exertion

Other

MeasureTime frameDescription
Relative maximal aerobic fitnessBaselineHighest value measured in ml.kg-1.min-1 during a treadmill graded exercise test.
Urine osmolalityBaselineMeasured using freezing point depression
Body massBaseline

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026