Effect of Aging and Aerobic Fitness Level on Heat Dissipation
Primary Purpose
Risk of Heat Stress
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Shuttle run test
Sponsored by
About this trial
This is an interventional prevention trial for Risk of Heat Stress focused on measuring heat loss, aging, aerobic fitness level, heat stress
Eligibility Criteria
Inclusion Criteria:
- Healthy children and adults
Exclusion Criteria:
- 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
Sites / Locations
- Department of Exercise Science, University of Thessaly
- FAME Lab, Department of Exercise Science, University of Thessaly
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Shuttle run test
Arm Description
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.
Outcomes
Primary Outcome Measures
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
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 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)
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
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 whole Body Sweat Rate
Whole Body Sweat Rate was determined by the difference of the pre-test and post-test weight of the participants
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
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04241900
Brief Title
Effect of Aging and Aerobic Fitness Level on Heat Dissipation
Official Title
Effect of Aging and Aerobic Fitness Level on Heat Dissipation in Neutral Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2014 (Actual)
Primary Completion Date
October 30, 2018 (Actual)
Study Completion Date
October 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Petros Dinas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
All trials were conducted to indoor gyms with the same environmental temperature and relative humidity, 26 - 30oC and 40-50% respectively, to ensure no difference in body temperature were due to the external thermal stress. The participants were instructed to refrain from intense exercise as well as alcohol and caffeine consumption for 24 hours prior to experimental trial and to had a light meal 2h before their arrival.
Upon arrival, participants would have to wear running shoes, light and short running shorts and light cotton socks. Participants received comprehensive instructions about the shuttle run test and the whole process of measurements. Firstly participants answered the International Physical Activity Questionnaire (IPAQ). Thereafter, anthropometrics data (weight and height) were evaluated as well as the body temperature in external ear canal and axillary. All participants followed five minutes warming up and then performed to 20 m shuttle run test until their volitional limit. Once the participants could no longer run, the test was over and the number of laps was recorded. After the end of the shuttle run, were evaluated the body temperature and the weight of each participants. No fluids consumptions were permitted until the second weighing. They were weighed twice, at baseline and at the end of the running test with a precision weight scale (Kern DE 150K2D, KERN & SOHN GmbH, Balingen, Germany).
Environmental data including air temperature and relative humidity were measured continuously using a portable weather station (LCD Digital Temperature & Humidity Meter HTC-1). The weather station was placed 1 meter above the ground according to the manufacturer's guidelines.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Risk of Heat Stress
Keywords
heat loss, aging, aerobic fitness level, heat stress
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
431 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Shuttle run test
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Shuttle run test
Intervention Description
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.
Primary Outcome Measure Information:
Title
Aerobic fitness level
Description
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
Time Frame
Through study completion (a shuttle run test), an average of 15 minutes
Title
Change from baseline ear canal temperature
Description
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)
Time Frame
Change from baseline to the end of study completion (a shuttle run test), an average of 15 minutes
Title
Change from baseline axillary temperature
Description
Axillary temperature was recorded twice, at baseline and at the end of the shuttle run test, using the electronic digital thermometer (EcoTemp, OMRON, Japan)
Time Frame
Change from baseline to the end of study completion (a shuttle run test), an average of 15 minutes
Title
Physical activity levels
Description
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
Time Frame
Once before the shuttle run test
Title
Change from baseline body weight
Description
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
Time Frame
Change from baseline to the end of study completion (a shuttle run test), an average of 15 minutes
Title
Change from baseline whole Body Sweat Rate
Description
Whole Body Sweat Rate was determined by the difference of the pre-test and post-test weight of the participants
Time Frame
Change from baseline to the end of study completion (a shuttle run test), an average of 15 minutes
Title
Air temperature
Description
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
Time Frame
Up to 30 minutes, during a one complete shuttle run test
Title
Relative humidity
Description
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
Time Frame
Up to 30 minutes, during a one complete shuttle run test
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy children and adults
Exclusion Criteria:
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
Facility Information:
Facility Name
Department of Exercise Science, University of Thessaly
City
Trikala
State/Province
Thessaly
ZIP/Postal Code
42100
Country
Greece
Facility Name
FAME Lab, Department of Exercise Science, University of Thessaly
City
Tríkala
State/Province
Thessaly
ZIP/Postal Code
42100
Country
Greece
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effect of Aging and Aerobic Fitness Level on Heat Dissipation
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