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CompletedNCT05303142Updated May 22, 2023

Comparing Exertional Heat Illness Risk Factors Between Patients and Controls

An observational study in Exertional Heat Illness, sponsored by University of Portsmouth. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-22.

Sponsored by University of Portsmouth · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
95
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Exertional Heat Illness

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03

In context

Heat Stress Disorders

111 studies on the registry are indexed under Heat Stress Disorders; 45 are open to participants now.

This study's enrollment of 95 is above the median of 55 across 13 observational studies indexed under Heat Stress Disorders.

Browse Heat Stress Disorders studies →

Lead sponsor

University of Portsmouth is the lead sponsor of 32 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Individuals who have experienced a recent exertional heat illness and matched controls with no previous history of exertional heat illness

Eligibility criteria

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
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
95 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Individuals with a history of EHI

    Service personnel who have a history of EHI.

    Other: Heat Tolerance Assessment

  • Control participants without a history of EHI

    Matched control participants with no history of EHI. They will be matched to the experimental group for parameters that are known to influence thermoregulatory responses to exercise heat-stress. 1. Relative aerobic fitness (V̇O2max; ml∙kg-1∙min-1) 2. Body mass (kg) 3. Body surface area (m2) 4. Age 5. Sex

    Other: Heat Tolerance Assessment

Interventions

  • OtherHeat Tolerance Assessment

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

06

What researchers measure

Primary outcomes

  1. Core temperature

    Measured using a rectal thermistor.

    Time frame: At 60 minutes (or test termination if earlier) of Heat Tolerance Assessment

  2. Core temperature

    Measured using a rectal thermistor.

    Time frame: Rate of rise from 30 to 60 minutes (or test termination if earlier) of Heat Tolerance Assessment

  3. Diversity of gastrointestinal microbiota

    Measured in stool sample. Assessed by alpha diversity score.

    Time frame: Baseline

  4. Diversity of gastrointestinal microbiota

    Measured in stool sample. Assessed by beta diversity score.

    Time frame: Baseline

  5. Abundance of gastrointestinal microbiota

    Measured in stool sample. Assessed at level of phylum.

    Time frame: Baseline

  6. Detection of sexually transmitted pathogens

    Assessed from urine sample. Measured using cobas CT/NG assays.

    Time frame: Baseline

  7. Detection of respiratory pathogens

    Assessed from throat swab. Measured using Allplex assays.

    Time frame: Baseline

  8. Detection of gastrointestinal pathogens

    Assessed from stool swab. Measured using Allplex.

    Time frame: Baseline

  9. Circulating Interleukin 6

    Measured using ELISA

    Time frame: Baseline

  10. Circulating Interleukin 6

    Measured using ELISA

    Time frame: Post Heat Tolerance Assessment (within 15 minutes of test end)

  11. Circulating C-Reactive Protein

    Measured using ELISA

    Time frame: Baseline

  12. Circulating C-Reactive Protein

    Measured using ELISA

    Time frame: Post Heat Tolerance Assessment (within 15 minutes of test end)

  13. Circulating Claudin 3

    Measured using ELISA

    Time frame: Baseline

  14. Circulating Claudin 3

    Measured using ELISA

    Time frame: Post Heat Tolerance Assessment (within 15 minutes of test end)

  15. Circulating Zonulin

    Measured using ELISA

    Time frame: Baseline

  16. Circulating lipopolysaccharide binding protein

    Measured using ELISA

    Time frame: Baseline

  17. Circulating lipopolysaccharide binding protein

    Measured using ELISA

    Time frame: Post Heat Tolerance Assessment (within 15 minutes of test end)

  18. Circulating intestinal fatty acid binding protein

    Measured using ELISA

    Time frame: Baseline

  19. Circulating intestinal fatty acid binding protein

    Measured using ELISA

    Time frame: Post Heat Tolerance Assessment (within 15 minutes of test end)

  20. Gastrointestinal illness symptomology questionnaire

    Visual analogue scale (0-10). Higher scores indicate worse symptomology

    Time frame: Baseline

  21. Gastrointestinal illness symptomology questionnaire

    Visual analogue scale (0-10). Higher scores indicate worse symptomology

    Time frame: Pre Heat Tolerance Assessment

  22. Gastrointestinal illness symptomology questionnaire

    Visual analogue scale (0-10). Higher scores indicate worse symptomology

    Time frame: Immediately post Heat Tolerance Assessment

  23. Respiratory illness symptomology, measured by Jackson common cold questionnaire

    Higher scores indicate worse symptomology

    Time frame: Baseline

  24. Sleep quality and quantity, measured by Pittsburgh Sleep Quality Index

    Higher scores indicate worse sleep

    Time frame: Baseline -3 days

  25. Motivation, measured by Motivation scale

    Time frame: Baseline -3 days

  26. State-trait anxiety, measured by state-trait anxiety inventory form Y-2

    Time frame: Baseline -3 days

  27. Risk taking, measured by the risk-taking inventory

    Time frame: Baseline -3 days

  28. Resilience, measured by the Connor-Davidson resilience scale

    Time frame: Baseline -3 days

  29. Stress, measured by perceived stress scale

    Time frame: Baseline -3 days

  30. Mental readiness

    Visual analogue scale (0-100). Higher scores indicate a lower state of mental readiness.

    Time frame: Baseline

  31. Stress

    Visual analogue scale (0-100). Higher scores indicate a greater state of stress.

    Time frame: Baseline

Secondary outcomes

  1. Heat rate

    Time frame: At 5 minute intervals during the Heat Tolerance Assessment

  2. Thermal comfort

    Modified 9 point Gagge scale. Higher scores indicate worse comfort.

    Time frame: At 15 minute intervals during Heat Tolerance Assessment

  3. Thermal sensation

    Modified 9 point Gagge scale. Higher scores indicate hotter sensation

    Time frame: At 15 minute intervals during Heat Tolerance Assessment

  4. Rating of Perceived Exertion

    6-20 Borg scale. Higher scores indicate higher perceived exertion

    Time frame: At 15 minute intervals during Heat Tolerance Assessment

  5. Skin Temperature

    Weighted mean skin temperature

    Time frame: During Heat Tolerance Assessment

  6. Sweat rate

    Determined from change in nude body mass during the heat tolerance assessment

    Time frame: During Heat Tolerance Assessment

Other outcomes

  1. Body mass

    Time frame: Baseline

  2. Relative maximal aerobic fitness

    Highest value measured in ml.kg-1.min-1 during a treadmill graded exercise test.

    Time frame: Baseline

  3. Urine osmolality

    Measured using freezing point depression

    Time frame: Baseline

07

Study locations

1 site
  • University of Portsmouth
    Portsmouth, Hampshire PO1 2UP, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05303142
Lead sponsor
University of Portsmouth
Collaborators
Liverpool John Moores University, Institute of Naval Medicine (UK), Headquarters Army Recruiting and Initial Training Command (UK), Public Health Wales (UK)
Responsible party
Jo Corbett (Principal Investigator, University of Portsmouth) — Principal investigator
First posted
Mar 31, 2022
Start date
Feb 1, 2022
Primary completion
Mar 6, 2023
Completion
Mar 6, 2023
Last update
May 22, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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