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临床试验/NCT05847465
NCT05847465招募中不适用

Study of Thermoregulation in Exercise Heat Stroke in the Military Environment

Direction Centrale du Service de Santé des Armées1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年5月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
Percentage of heat intolerant individuals based on the Heat Tolerance Test

研究概览

简要总结

The EXPLO-MITO study is an ancillary study from the main EXPLO-CCE study (NCT04593316; IDRCB: 2020-A01967-32).

The Heat Tolerance Test (HTT) is a physiological exploration that has several advantages for use in research and clinical settings. Unlike the walk-run test, it is performed under controlled conditions, both environmentally (temperature control, humidity, etc.) and in terms of effort intensity. In addition, there are published interpretation criteria for this test allowing to characterize thermoregulation profiles and to distinguish between Heat Intolerant (HI) and Heat Tolerant (HT) patients.

The reproducibility of this test and its performance in a climatic chamber allows a true comparison of thermophysiological responses (heart rate, rectal and skin temperatures, skin blood flow and sweat loss), which was not possible with the run-walk test, which was more a field test validating a physical aptitude for recovery (so-called "occupational" test) than a physiological exploration evaluating a response to stress by comparing it with the expected response in a population of young, healthy, properly trained subjects. Moreover, the HTT is a much less physiologically demanding test than the 8-km run. The HTT, which corresponds to a 2-hour walk at 5 km/h with a 2% slope at 40°C and 40% relative humidity, is a so-called "compensable" thermal stress; that is, under these conditions of exercise and environment, when the individual has normal thermoregulatory capacities, a thermal equilibrium plateau is reached during the second hour, when the individual's thermolysis capacities make it possible to compensate for the production of heat by the exercise and the gain of heat related to the environment. On average, this plateau is between 38° and 39°C. This is clearly not the case with our experience of physiological monitoring of the 8-km walk-run which rarely allows a temperature plateau to be reached and is accompanied by a temperature rise constantly above 39°C. In addition to being performed in the laboratory, this test is therefore completely safe.

For all these reasons (reproducibility, relevance, predictive value of recurrence), this test has been used for more than 30 years by the Israeli army for the assessment of these cases of exercise heat stroke before their return to work. There is therefore a fair amount of published data and hindsight on the use and interest of this test. The Israeli test has the highest level of recommendation (Grade A) of all the other published heat tolerance tests. Also, the availability of a climatic chamber means that this test can now be proposed as one of the explorations available to clinicians who have to decide on the fitness of soldiers after exercise heat stroke.

研究设计

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

入排标准

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

入选标准

  • Be included in the main EXPLO-CCE study;
  • Subject trained or re-trained at 2 aerobic sessions per week;
  • At least 2 months from the exercise heat stroke experience

排除标准

  • Subject with a current medication treatment (for the control group only),
  • Subject with a contraindication to the ingestion of a thermal capsule, namely:
  • Weight less than 37 kg
  • Inflammatory, motor or obstructive disease of the digestive tract
  • History of digestive surgery
  • Participant requiring a CT or MRI scan prior to removal of the thermal capsule (scheduled scan)
  • Presence of an implantable electronic device (e.g. pacemaker)

结局指标

主要结局

Percentage of heat intolerant individuals based on the Heat Tolerance Test

时间窗: Through study completion (48 months)

Classification of participants between Heat Intolerant (HI) and Heat Tolerant (HT) will be determined according to measured rectal temperature. Participants will be classified as HI if they have at least one of the following criteria at HTT: * Rectal temperature \> 38.5°C at the end of the 2 hours * Rectal temperature change during the second hour \> 0.45°C

次要结局

未报告次要终点

研究者

发起方
Direction Centrale du Service de Santé des Armées
申办方类型
Other
责任方
Sponsor

研究点 (1)

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