Non-invasive Prediction of Thermal Strain in Healthy Male Adults

NCT04650776 | Completed

• 1 other identifier: 5213.00095
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Heat Stress

Outcome Measures

Primary Outcomes (3)

• Core body temperature

  Rectal core body temperature (unit of measure is degree celsius °C)

  90 minutes

• Predicted core body temperature

  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)

  90 minutes

• ECG-based heat strain index

  ECG-based index of heat strain derived from heart rate variability

  90 minutes

Study Arms (2)

High heat strain

EXPERIMENTAL

participants exercised at 75% of their heart rate maximum (HR max) and wore light athletic clothing (t-shirt and shorts)

Other: Heat strain

Low heat strain

EXPERIMENTAL

participants exercised at 50% HR max, wearing protective firefighter clothing (jacket and trousers)

Other: Heat strain

Interventions

Heat strain OTHER

The experimental procedure comprised 15 min baseline seated rest (23.2 ± 0.3°C, 24.5 ± 1.6% relative humidity), followed by 15 min seated rest and cycling in a climatic chamber (35.4 ± 0.2◦C, 56.5 ± 3.9% relative humidity; to +1.5◦C or maximally 38.5°C rectal temperature, duration 20-60 min), with a final 30 min seated rest outside the chamber.

High heat strain; Low heat strain

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Simon Annaheim: lead

Study Sites (1)

Empa

Sankt Gallen, Canton of St. Gallen, 9014, Switzerland

Location

Related Links

• Published manuscript

MeSH Terms

Conditions

Heat Stress Disorders

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Simon Annaheim, Dr.

  Empa, Swiss Federal Laboratories for Materials Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: December 3, 2020
• Study Start: September 1, 2017
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: December 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)