- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04241900
Effect of Aging and Aerobic Fitness Level on Heat Dissipation
Effect of Aging and Aerobic Fitness Level on Heat Dissipation in Neutral Conditions
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Thessaly
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Trikala, Thessaly, Greece, 42100
- Department of Exercise Science, University of Thessaly
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Tríkala, Thessaly, Greece, 42100
- FAME Lab, Department of Exercise Science, University of Thessaly
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Shuttle run test
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Aerobic fitness level
Time Frame: Through study completion (a shuttle run test), an average of 15 minutes
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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
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Through study completion (a shuttle run test), an average of 15 minutes
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Change from baseline ear canal temperature
Time Frame: Change from baseline to the end of study completion (a shuttle run test), an average of 15 minutes
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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)
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Change from baseline to the end of study completion (a shuttle run test), an average of 15 minutes
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Change from baseline axillary temperature
Time Frame: Change from baseline to the end of study completion (a shuttle run test), an average of 15 minutes
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Axillary temperature was recorded twice, at baseline and at the end of the shuttle run test, using the electronic digital thermometer (EcoTemp, OMRON, Japan)
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Change from baseline to the end of study completion (a shuttle run test), an average of 15 minutes
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Physical activity levels
Time Frame: Once before the shuttle run test
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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
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Once before the shuttle run test
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Change from baseline body weight
Time Frame: Change from baseline to the end of study completion (a shuttle run test), an average of 15 minutes
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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
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Change from baseline to the end of study completion (a shuttle run test), an average of 15 minutes
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Change from baseline whole Body Sweat Rate
Time Frame: Change from baseline to the end of study completion (a shuttle run test), an average of 15 minutes
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Whole Body Sweat Rate was determined by the difference of the pre-test and post-test weight of the participants
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Change from baseline to the end of study completion (a shuttle run test), an average of 15 minutes
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Air temperature
Time Frame: Up to 30 minutes, during a one complete shuttle run test
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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
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Up to 30 minutes, during a one complete shuttle run test
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Relative humidity
Time Frame: Up to 30 minutes, during a one complete shuttle run test
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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
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Up to 30 minutes, during a one complete shuttle run test
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10. Aging and heat loss
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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