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Non-invasive Prediction of Thermal Strain in Healthy Male Adults

NCT ID: NCT04650776

Last Updated: 2020-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2018-04-30

Brief Summary

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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

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Conditions

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Heat Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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High heat strain

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

Group Type EXPERIMENTAL

Heat strain

Intervention Type 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.

Low heat strain

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

Group Type EXPERIMENTAL

Heat strain

Intervention Type 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.

Interventions

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Heat strain

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.

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Simon Annaheim

OTHER

Sponsor Role lead

Responsible Party

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Simon Annaheim

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Simon Annaheim, Dr.

Role: PRINCIPAL_INVESTIGATOR

Empa, Swiss Federal Laboratories for Materials Science and Technology

Locations

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Empa

Sankt Gallen, Canton of St. Gallen, Switzerland

Site Status

Countries

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Switzerland

Related Links

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https://www.frontiersin.org/articles/10.3389/fphys.2018.01780/full

Published manuscript

Other Identifiers

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5213.00095

Identifier Type: -

Identifier Source: org_study_id