Risk Factors for Exertional Heat Illness

Sponsor
Liverpool John Moores University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04979455
Collaborator
Institute of Naval Medicine (UK) (Other), CTCRM Lympstone (UK) (Other), University of Portsmouth (UK) (Other), Public Health Wales (UK) (Other), Bangor University (UK) (Other), Headquarters Army Recruiting and Initial Training Command (UK) (Other), Defence Science and Technology (UK) (Other)
979
1
27.7
35.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Core temperature monitoring
  • Behavioral: Questionnaires
  • Other: Heart rate monitoring
  • Other: Urine collection
  • Other: Sleep monitoring
  • Other: Blood collection
  • Other: Saliva collection
  • Other: Throat swab collection
  • Other: Stool collection

Study Design

Study Type:
Observational
Anticipated Enrollment :
979 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prospective Investigation of Risk Factors for Exertional Heat Illness
Actual Study Start Date :
Jun 11, 2021
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Exertional heat illness

Participants who experience an atypical elevation in thermal strain or an EHI undergoing strenuous physical exercise.

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

Other: Urine collection
Urine samples will be collected at baseline and on the day of exercise

Other: Sleep monitoring
Sleep will be monitored at baseline and on the day of exercise

Other: Blood collection
Blood samples will be completed at baseline

Other: Saliva collection
Saliva samples will be collected at baseline and on the day of exercise

Other: Throat swab collection
Throat swab samples will be collected at baseline and on the day of exercise

Other: Stool collection
Stool samples will be collected at baseline and on the day of exercise

Control

Participants who do not experience an atypical elevation in thermal strain or an EHI undergoing strenuous physical exercise.

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

Other: Urine collection
Urine samples will be collected at baseline and on the day of exercise

Other: Sleep monitoring
Sleep will be monitored at baseline and on the day of exercise

Other: Blood collection
Blood samples will be completed at baseline

Other: Saliva collection
Saliva samples will be collected at baseline and on the day of exercise

Other: Throat swab collection
Throat swab samples will be collected at baseline and on the day of exercise

Other: Stool collection
Stool samples will be collected at baseline and on the day of exercise

Outcome Measures

Primary Outcome Measures

  1. Body mass index in EHI and control group [Baseline]

  2. Fitness in EHI and control group - participants ranked by time to complete fitness test [Baseline]

  3. Core temperature in EHI and control group [1 Day]

  4. Heart rate in EHI and control group [2 Hours]

  5. Urine osmolality in EHI and control group [Baseline]

  6. Sleep quality and quantity, measured by Pittsburgh Sleep Quality Index, in EHI and control group [Throughout study - up to 1 week]

    0-21 Scale. Higher score indicates worse outcome

  7. Sleep quality, measured by actigraphy, between EHI and control group [Throughout study - up to 1 week]

  8. Sleep quantity, measured by actigraphy, between EHI and control group [Throughout study - up to 1 week]

  9. Circulating Interleukin 6 in EHI and control group [Baseline]

  10. Circulating C-Reactive Protein in EHI and control group [Baseline]

  11. Circulating Creatine kinase in EHI and control group [Baseline]

  12. Circulating Aspartate Aminotransferase in EHI and control group [Baseline]

  13. Circulating Alanine Aminotransferase in EHI and control group [Baseline]

  14. Circulating Claudin 3 in EHI and control group [Baseline]

  15. Circulating Zonulin in EHI and control group [Baseline]

  16. Circulating Lipopolysaccharide binding protein in EHI and control group [Baseline]

  17. Circulating immunoglobulin E in EHI and control group [Baseline]

  18. Salivary cortisol in EHI and control group [Throughout study - up to 1 week]

  19. Detection of infectious pathogens in EHI and control groups [Throughout study - up to 1 week]

  20. Respiratory illness symptomology, measured by Jackson common cold questionnaire, in EHI and control group [Throughout study - up to 1 week]

    0-24 Scale. Higher score indicates worse outcome

  21. Gastrointestinal illness symptomology, measured by gastrointestinal symptoms questionnaire, in EHI and control group [Throughout study - up to 1 week]

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

  22. Abundance and diversity of gastrointestinal microbiota in EHI and control group [Baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:
17 Years to 35 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Men and women aged 17-35 years enrolled in military training
Exclusion Criteria:
  • Self-report as pregnant

Contacts and Locations

Locations

Site City State Country Postal Code
1 Commando Training Centre Royal Marine Lympstone Devon United Kingdom EX8 5AR

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Liverpool John Moores University
ClinicalTrials.gov Identifier:
NCT04979455
Other Study ID Numbers:
  • 2029/MODREC/21
First Posted:
Jul 28, 2021
Last Update Posted:
Jul 28, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 28, 2021