Single-centre Experimental Evaluation of Methods for Reliable Non-invasive Prediction of Thermal Strain in Healthy Male Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Predicted core body temperature
研究概览
简要总结
This is primarily an experimental study investigating methods of temperature measurement / heat strain detection. In the calibration study, there are different skin temperature sensor types, and in the prediction study there are different methods for determining heat strain, including conventional methods (rectal, gastro-intestinal), the development of a prediction model, and an index based on heart rate variability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Apparently healthy males
- •aged 18-45 y
- •regularly participate in sport, exercise, or equivalent physical activity on a weekly basis.
排除标准
- •Known injuries or illnesses that may affect safe participation. These include injuries or illnesses involving (but not limited to):
- •cardiovascular, renal, or gastrointestinal tract
- •heat or exercise intolerance
- •acute infections,
- •immunological diseases (including asthma)
- •psychiatric disorders.
- •Participants must not be currently or previously on cardiovascular-related medication and must not be taking psychotropic medication (last 60 days).
研究组 & 干预措施
High heat strain
participants exercised at 75% of their heart rate maximum (HR max) and wore light athletic clothing (t-shirt and shorts)
干预措施: Heat strain (Other)
Low heat strain
participants exercised at 50% HR max, wearing protective firefighter clothing (jacket and trousers)
干预措施: Heat strain (Other)
结局指标
主要结局
Predicted core body temperature
时间窗: 90 minutes
Estimated core body temperature (°C) from selected non-invasive measurements: applying a multiple linear regression model several predictive parameters, including skin temperature at different body sites, heat flux at different body sites, and heart rate will be combined to achieve one reported temperature value (°C)
Core body temperature
时间窗: 90 minutes
Rectal core body temperature (unit of measure is degree celsius °C)
ECG-based heat strain index
时间窗: 90 minutes
ECG-based index of heat strain derived from heart rate variability
次要结局
未报告次要终点
研究者
Simon Annaheim
Principal Investigator
Empa, Swiss Federal Laboratories for Materials Science and Technology