Non-invasive Prediction of Thermal Strain in Healthy Male Adults

Not Applicable

Completed

• Conditions: Heat Stress
• Interventions: Other: Heat strain

• Registration Number: NCT04650776
• Lead Sponsor: Simon Annaheim

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-01
• Primary Completion: 2018-04-30
• Study Completion: 2018-04-30
• Status Verified: 2020-11
• Study First Submitted: 2020-11-19
• Study First Submitted QC: 2020-11-25
• Last Update Submitted: 2020-11-25
• Study First Posted: 2020-12-03
• Last Update Posted: 2020-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 13

Inclusion Criteria

• Apparently healthy males
• aged 18-45 y
• regularly participate in sport, exercise, or equivalent physical activity on a weekly basis.

Exclusion Criteria

• 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High heat strain	Heat strain	participants exercised at 75% of their heart rate maximum (HR max) and wore light athletic clothing (t-shirt and shorts)
Low heat strain	Heat strain	participants exercised at 50% HR max, wearing protective firefighter clothing (jacket and trousers)

Primary Outcome Measures

Name	Time	Method
Predicted core body temperature	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	90 minutes	Rectal core body temperature (unit of measure is degree celsius °C)
ECG-based heat strain index	90 minutes	ECG-based index of heat strain derived from heart rate variability

Trial Locations

Locations (1)

Empa; 🇨🇭 St.Gallen, SG, Switzerland