Risk of Heat StressNCT04241900
Effect of Aging and Aerobic Fitness Level on Heat Dissipation
A study testing Shuttle run test in people with Risk of Heat Stress, run by Petros Dinas at 2 sites in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Risk of Heat Stress
- What is being tested?
- Shuttle run test
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 431 participants
- Where
- 2 sitesGreece
- Study dates
- 1 May 2014to 30 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy children and adults
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
Department of Exercise Science, University of Thessaly
Trikala, Thessaly, 42100
FAME Lab, Department of Exercise Science, University of Thessaly
Trikala, Thessaly, 42100
About this study
Official title: Effect of Aging and Aerobic Fitness Level on Heat Dissipation in Neutral Conditions
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.
Read the 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.
- Conditions
- Risk of Heat Stress
- Being tested
- Shuttle run test
- Keywords
- heat loss, aging, aerobic fitness level, heat stress
- Medical subject headings
- Heat Stress Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shuttle run testBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Shuttle run test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 30 minutes, during a one complete shuttle run test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start1 May 2014
- Primary completion30 Oct 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk of Heat StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 431 participants (actual)
Sponsor and investigators
- Lead sponsor
- Petros Dinas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Petros Dinas, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04241900
- Sponsor's protocol ID
- 10. Aging and heat loss
- Status last verified
- Jan 2020
- First submitted
- 16 Jan 2020
- Last updated
- 27 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aging and Aerobic Fitness Level on Heat Dissipation in Neutral Conditions
- ClinicalTrials.gov ID
- NCT04241900
- Acronym / sponsor ID
- 10. Aging and heat loss
- Conditions
- Risk of Heat Stress
- Keywords
- heat loss, aging, aerobic fitness level, heat stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 431 participants (actual)
- Lead sponsor
- Petros DinasUniversity, hospital or other
- Study start
- 1 May 2014 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shuttle run test | Experimental | Behavioral: Shuttle run testAt 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. |
Who may qualify
- Ages
- 9 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Healthy children and adults
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shuttle run testAt 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. | Behavioural | Shuttle run test |
Primary outcome
Aerobic fitness level
Time frame: Through study completion (a shuttle run test), an average of 15 minutes
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
Time frame: Change from baseline to the end of study completion (a shuttle run test), an average of 15 minutes
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
Time frame: Change from baseline to the end of study completion (a shuttle run test), an average of 15 minutes
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
Time frame: Once before the shuttle run test
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
Time frame: Change from baseline to the end of study completion (a shuttle run test), an average of 15 minutes
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
Time frame: Change from baseline to the end of study completion (a shuttle run test), an average of 15 minutes
Whole Body Sweat Rate was determined by the difference of the pre-test and post-test weight of the participants
Air temperature
Time frame: Up to 30 minutes, during a one complete shuttle run test
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
Time frame: Up to 30 minutes, during a one complete shuttle run test
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shuttle run test in people with Risk of Heat Stress, run by Petros Dinas at 2 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aerobic fitness level (time frame: Through study completion (a shuttle run test), an average of 15 minutes). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.