NCT04241900

Brief Summary

In the context of global aging, the health risk factors associated with exercising or working in the heat for aging population are exacerbated by the rising in global surface temperatures. The purpose of this investigation is to determine at what age the heat loss decrements occur and to examine if aerobic fitness level can affect the heat loss capacity in neutral environmental conditions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
431

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

4.5 years

First QC Date

January 16, 2020

Last Update Submit

January 22, 2020

Conditions

Keywords

heat lossagingaerobic fitness levelheat stress

Outcome Measures

Primary Outcomes (8)

  • Aerobic fitness level

    Aerobic fitness level was defined by peak oxygen uptake (VO2peak). VO2peak was determined by a 20m shuttle run test. The number of the last announced stage and the equivalent maximal speed from participants' performance were used for its VO2peak estimation

    Through study completion (a shuttle run test), an average of 15 minutes

  • Change from baseline ear canal temperature

    Ear canal temperature was recorded twice, at baseline and at the end of the shuttle run test (three times each at the left ear and recorded the mean value), using ear thermometer (IR100, MicrolifeSwitzerland)

    Change from baseline to the end of study completion (a shuttle run test), an average of 15 minutes

  • Change from baseline axillary temperature

    Axillary temperature was recorded twice, at baseline and at the end of the shuttle run test, using the electronic digital thermometer (EcoTemp, OMRON, Japan)

    Change from baseline to the end of study completion (a shuttle run test), an average of 15 minutes

  • Physical activity levels

    Physical activity of the subject in a usual week was recorded via International Physical Activity Questionnaire. Scores include steps/day and METs/week, with no lower and upper limit

    Once before the shuttle run test

  • Change from baseline body weight

    Weight was recorded twice, at baseline and at the end of the shuttle run test, using a precision weight scale (Kern DE 150K2D, KERN \& SOHN GmbH, Balingen, Germany

    Change from baseline to the end of study completion (a shuttle run test), an average of 15 minutes

  • Change from baseline whole Body Sweat Rate

    Whole Body Sweat Rate was determined by the difference of the pre-test and post-test weight of the participants

    Change from baseline to the end of study completion (a shuttle run test), an average of 15 minutes

  • Air temperature

    Air temperature was measured continuously using a portable weather station (LCD Digital Temperature \& Humidity Meter HTC-1placed) 1 meter above the ground according to the manufacturer's guidelines

    Up to 30 minutes, during a one complete shuttle run test

  • Relative humidity

    Relative humidity was measured continuously using a portable weather station (LCD Digital Temperature \& Humidity Meter HTC-1) placed 1 meter above the ground according to the manufacturer's guidelines

    Up to 30 minutes, during a one complete shuttle run test

Study Arms (1)

Shuttle run test

EXPERIMENTAL

At the shuttle run test, participants were required to run between two lines 20 meters apart, while keeping pace with audio signals emitted from a pre-recorded CD. The frequency of the sound signals increases in such way that running speed was increased by 0.5 km h-1 each minute from the starting speed 8.5 km h-1.

Behavioral: Shuttle run test

Interventions

At the shuttle run test, participants were required to run between two lines 20 meters apart, while keeping pace with audio signals emitted from a pre-recorded CD. The frequency of the sound signals increases in such way that running speed was increased by 0.5 km h-1 each minute from the starting speed 8.5 km h-1.

Shuttle run test

Eligibility Criteria

Age9 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Healthy children and adults

You may not qualify if:

  • Diagnosed chronic medical condition;
  • Symptoms of acute illness;
  • Recent (past 4 weeks) usage of medications known to affect the circulatory system, the thyroid, the pituitary function, or the metabolic status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Exercise Science, University of Thessaly

Trikala, Thessaly, 42100, Greece

Location

FAME Lab, Department of Exercise Science, University of Thessaly

Trikala, Thessaly, 42100, Greece

Location

MeSH Terms

Conditions

Heat Stress Disorders

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Researcher in human physiology

Study Record Dates

First Submitted

January 16, 2020

First Posted

January 27, 2020

Study Start

May 1, 2014

Primary Completion

October 30, 2018

Study Completion

October 30, 2018

Last Updated

January 27, 2020

Record last verified: 2020-01

Locations