跳至主要内容
临床试验/NCT05303142
NCT05303142已完成不适用

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

University of Portsmouth1 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
95
试验地点
1
主要终点
Diversity of gastrointestinal microbiota

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

结局指标

主要结局

Diversity of gastrointestinal microbiota

时间窗: Baseline

Measured in stool sample. Assessed by beta diversity score.

Circulating Interleukin 6

时间窗: Post Heat Tolerance Assessment (within 15 minutes of test end)

Measured using ELISA

Abundance of gastrointestinal microbiota

时间窗: Baseline

Measured in stool sample. Assessed at level of phylum.

Detection of sexually transmitted pathogens

时间窗: Baseline

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

Detection of respiratory pathogens

时间窗: Baseline

Assessed from throat swab. Measured using Allplex assays.

Detection of gastrointestinal pathogens

时间窗: Baseline

Assessed from stool swab. Measured using Allplex.

Circulating Claudin 3

时间窗: Post Heat Tolerance Assessment (within 15 minutes of test end)

Measured using ELISA

Circulating C-Reactive Protein

时间窗: Post Heat Tolerance Assessment (within 15 minutes of test end)

Measured using ELISA

Circulating Zonulin

时间窗: Baseline

Measured using ELISA

Circulating lipopolysaccharide binding protein

时间窗: Post Heat Tolerance Assessment (within 15 minutes of test end)

Measured using ELISA

Circulating intestinal fatty acid binding protein

时间窗: Post Heat Tolerance Assessment (within 15 minutes of test end)

Measured using ELISA

Gastrointestinal illness symptomology questionnaire

时间窗: Immediately post Heat Tolerance Assessment

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

Respiratory illness symptomology, measured by Jackson common cold questionnaire

时间窗: Baseline

Higher scores indicate worse symptomology

Sleep quality and quantity, measured by Pittsburgh Sleep Quality Index

时间窗: Baseline -3 days

Higher scores indicate worse sleep

Motivation, measured by Motivation scale

时间窗: Baseline -3 days

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

时间窗: Baseline -3 days

Risk taking, measured by the risk-taking inventory

时间窗: Baseline -3 days

Stress, measured by perceived stress scale

时间窗: Baseline -3 days

Mental readiness

时间窗: Baseline

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

Stress

时间窗: Baseline

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

Resilience, measured by the Connor-Davidson resilience scale

时间窗: Baseline -3 days

Core temperature

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

Measured using a rectal thermistor.

次要结局

  • Rating of Perceived Exertion(At 15 minute intervals during Heat Tolerance Assessment)
  • Skin Temperature(During Heat Tolerance Assessment)
  • Sweat rate(During Heat Tolerance Assessment)
  • Heat rate(At 5 minute intervals during the Heat Tolerance Assessment)
  • Thermal comfort(At 15 minute intervals during Heat Tolerance Assessment)
  • Thermal sensation(At 15 minute intervals during Heat Tolerance Assessment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jo Corbett

Principal Investigator

University of Portsmouth

研究点 (1)

Loading locations...

相似试验

Comparing Exertional Heat Illness Risk Factors... | 临床试验