Risk of Heat StressNCT04197375
Impact of Pre-cooling in Adolescent Tennis Athletes
A study testing Thermal stress and performance using a pre-cooling protocol and Thermal stress and performance without a pre-cooling protocol in people with Risk of Heat Stress, run by Petros Dinas at 1 site in Greece.
Trial summary
Many tennis tournaments are played outdoors in hot and humid conditions, which poses a significant challenge particularly for children athletes. The purpose of this investigation is to examine if a precooling method can reduce thermal strain and consequently improve the performance of adolescent tennis athletes while… Read more about this study
- Who is it for?
- Ages 14 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Risk of Heat Stress
- What is being tested?
- Thermal stress and performance using a pre-cooling protocol and Thermal stress and performance without a pre-cooling protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteGreece
- Study dates
- 1 Aug 2018to 30 Sep 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 14 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy adolescent athletes
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
1 site in 1 country.
Greece1 site
FAME Lab, Department of Exercise Science, University of Thessaly
Trikala, Thessaly, 42100
About this study
Official title: Impact of Pre-cooling in Adolescent Athletes While Playing Tennis in Hot Conditions
Many tennis tournaments are played outdoors in hot and humid conditions, which poses a significant challenge particularly for children athletes. The purpose of this investigation is to examine if a precooling method can reduce thermal strain and consequently improve the performance of adolescent tennis athletes while exercising in hot conditions.
Read the detailed description
Matches were conducted on hard-court surfaces separated by 24h (n=4 pairs) or 144h (n=1pair) between 9am and 6pm and were played in winning two sets. Participants were paired according to their level of play and competed against the same component at the same time of the day in both matches.
Three hours before the start of their scheduled match, each player ingested a telemetric pill in order to estimate the visceral temperature. Upon arrival, all participants provided a urine sample for assessment of urine specific gravity as an indicator of their hydration status and they emptied their bladders before were weighed. They were weighed twice, at baseline and at the end of the match with a precision weight scale (Kern DE 150K2D, KERN \& SOHN GmbH, Balingen, Germany). During the match the participants consumed water and any other sport drink and food ad libitum. The total weight of the players' food and fluids that was consumed was measured using a precision weight scale. If participants wished to urinate during the match, they were asked to use a urine cup and their urine was weighed.
One hour before the match, the precooling group was wearing a Cooling Cap (WElkins Sideline Cooling System, SCS) for 45 minutes. On removal from a -20oC freezer, the cap surface was 10.7±2.5oC. After 45 minutes, participants removed the cap and they performed a 5 minutes standardized warm-up (running around the court and running exercises from baseline to net and back to baseline) and 10 min tennis specific warm up (rallies and serves) on court. Each participant, before the warm-up, was outfitted with a heart rate chest strap and iBUTTON sensors at four sites of the body (chest, upper arm, thigh and calf).
The scoring and timing characteristics of the matches complied with 2016 ITF rules. Three new balls were used for each match with the players retrieving balls between points. Matches were filmed from one end of the court, using a digital video camera (Sony DCR-VX2000E PAL, Japan). Participants were performed on perceptual measurements at baseline, after each set, and at the end of the match.
Thermoregulatory, cardiovascular and perceptual responses were recorded with standardized techniques: 1) visceral temperature using telemetric pill (BodyCap, Caen, France) was continuously recorded throughout the match; 2) skin temperature using iBUTTON sensors (type DS1921 H, Maxim/Dallas Semiconductor Corp., USA) on chest, upper arm, thigh and calf was recorded continuously; 3) heart rate (HR) variability data were sampled through short-range telemetry at 1,000 Hz with a Polar RS800CX (Polar Electro , Kempele, Finland). The heart rate monitor signal will be transferred to the Polar Precision Performance Software (release 3.00; Polar Electro Oy); 4) thermal comfort (scale 1-5), thermal sensation (scale 1-10) and rating of perceived exertion using standardized questionnaires were recorded at baseline, after each set, and at the end of the match.
Hydration status was recorded with urine specific gravity. All the collected urine samples will be analyzed using a refractrometer (Atago, Tokyo, Japan) for the determination of urine specific gravity. Euhydration will be defined as urine specific gravity <1.02 according to internationally accepted standards.
A digital video camera (Sony DCR-VX2000E PAL, Japan) was used to record the match - play characteristics. The footage was used to conduct the retrospective notational analysis. The quantitative performance indices that assessed had been: games and points won in each set and normalized to the number of games and points that record in each set respectively. Also unforced errors, first and second serve accuracy, aces, shots per rally and direction changes in each point calculated. Point's duration, between point-duration as well the effective point time calculated. The effective point time starting with the ball toss of the serve and ending when the ball passed the player or bounced twice on court. In case of double fault, starting time recorded from the beginning of the second serve.
Environmental data including air temperature, relative humidity, and wind speed were measured continuously using a portable weather station (Kestrel 5500FW Fire Weather Meter Pro, USA). The weather station was placed 1 meter above the ground according to the manufacturer's guidelines.
- Conditions
- Risk of Heat Stress
- Being tested
- Thermal stress and performance using a pre-cooling protocol, Thermal stress and performance without a pre-cooling protocol
- Keywords
- heat stress, heat strain, performance, children, exercise, thermal
- Medical subject headings
- Heat Stress Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal stress and performance using a pre-cooling protocolBehavioural
One hour before a tennis match, participants were wearing a Cooling Cap (WElkins Sideline Cooling System, SCS) for 45 minutes. During the tennis match the following variables were monitored: heart rate, core temperature, skin temperature, thermal sensation and comfort, rating of perceived exertion and hydration status.
Thermal stress and performance without a pre-cooling protocolBiological
During a tennis match the following variables were monitored: heart rate, core temperature, skin temperature, thermal sensation and comfort, rating of perceived exertion and hydration status.
| Study group | Role | What they receive |
|---|---|---|
| Pre-cooling scenario | Experimental | One hour before a tennis match, the pre-cooling group was wearing a Cooling Cap (WElkins Sideline Cooling System, SCS) for 45 minutes. Receives: Behavioral: Thermal stress and performance using a pre-cooling protocol |
| Sham evaluation | Sham comparator | Participants were monitored during a usual game without any kind of pre-cooling strategy Receives: Biological: Thermal stress and performance without a pre-cooling protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
Heart rate data were continuously monitored using a Polar Team system (Polar® Team 2, Polar Electro Oy, Kempele, Finland
Measured: Up to 4 hours, during a one complete tennis match
Core temperature
Visceral temperature was continuously recorded throughout the match using telemetric pills (BodyCap, Caen, France)
Measured: Up to 4 hours, during a one complete tennis match
Skin temperature
Skin temperature was continuously recorded throughout the match using iBUTTON sensors (type DS1921 H, Maxim/Dallas Semiconductor Corp., USA)
Measured: Up to 4 hours, during a one complete tennis match
Change from baseline thermal comfort at after each set
Thermal comfort was assessed via the thermal comfort scale (1 = comfortable; 5 = extremely uncomfortable).
Measured: Change from baseline up to 1 hour after each set and up to 4 hours at the end of the match
Change from baseline thermal sensation at after each set
Thermal sensation was assessed via the thermal sensation scale (-3 = cold; +3 = hot)
Measured: Change from baseline up to 1 hour after each set and up to 4 hours at the end of the match
Change from baseline rating of perceived exertion at after each set
We used the Borg 20th Scale (6 = no exertion at all; 20 = maximal exertion)
Measured: Change from baseline up to 1 hour after each set and up to 4 hours at the end of the match
Change from baseline urine specific gravity (hydration status) at the end of each match
Urine samples was obtained to evaluate the urine specific gravity. Urine specific gravity (single assessmentno units) was assessed using a refractometer (PAL-10S, ATAGO CO., LTD., Fukaya, Saitama Prefecture, Japan). Urine color was assessed using a urine color scale
Measured: Change from baseline up to 4 hours at the end of the tennis match
Match - play characteristics (i.e., performance)
They were recorded by analyzing the video footage from the match. The quantitative performance indices assessed were: games and points won in each set and normalized to the number of games and points recorded in each set, respectively. Unforced errors, first and second serve accuracy, aces, shots per rally and direction changes in each point calculated. Point's duration, between point-duration as well the effective point time calculated. The effective point time starting with the ball toss of the serve and ending when the ball passed the player or bounced twice on court. In case of double fault, starting time recorded from the beginning of the second serve.
Measured: Up to 4 hours, during a one complete tennis match
Air temperature
It was measured continuously using a portable weather station (Kestrel 5500FW Fire Weather Meter Pro, USA) placed 1 meter above the ground according to the manufacturer's
Measured: Up to 4 hours, during a one complete tennis match
Relative humidity
It was measured continuously using a portable weather station (Kestrel 5500FW Fire Weather Meter Pro, USA) placed 1 meter above the ground according to the manufacturer's guidelines
Measured: Up to 4 hours, during a one complete tennis match
Wind speed
It was measured continuously using a portable weather station (Kestrel 5500FW Fire Weather Meter Pro, USA) placed 1 meter above the ground according to the manufacturer's guidelines
Measured: Up to 4 hours, during a one complete tennis match
Solar radiation
It was measured continuously using a portable weather station (Kestrel 5500FW Fire Weather Meter Pro, USA) placed 1 meter above the ground according to the manufacturer's guidelines. Solar radiation is measured directly by the device of portable weather station.
Measured: Up to 4 hours, during a one complete tennis match
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start1 Aug 2018
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 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
- NCT04197375
- Sponsor's protocol ID
- 8. Tennis pre-cooling
- Status last verified
- Dec 2019
- First submitted
- 7 Dec 2019
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Misailidi M, Mantzios K, Papakonstantinou C, Ioannou LG, Flouris AD. Environmental and Psychophysical Heat Stress in Adolescent Tennis Athletes. Int J Sports Physiol Perform. 2021 Dec 1;16(12):1895-1900. doi: 10.1123/ijspp.2020-0820. Epub 2021 May 21.
PubMed 34021093
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pre-cooling in Adolescent Athletes While Playing Tennis in Hot Conditions
- ClinicalTrials.gov ID
- NCT04197375
- Acronym / sponsor ID
- 8. Tennis pre-cooling
- Conditions
- Risk of Heat Stress
- Keywords
- heat stress, heat strain, performance, children, exercise, thermal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Petros DinasUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 13 Dec 2019 (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.
Many tennis tournaments are played outdoors in hot and humid conditions, which poses a significant challenge particularly for children athletes. The purpose of this investigation is to examine if a precooling method can reduce thermal strain and consequently improve the performance of adolescent tennis athletes while exercising in hot conditions.
Detailed description
Matches were conducted on hard-court surfaces separated by 24h (n=4 pairs) or 144h (n=1pair) between 9am and 6pm and were played in winning two sets. Participants were paired according to their level of play and competed against the same component at the same time of the day in both matches.
Three hours before the start of their scheduled match, each player ingested a telemetric pill in order to estimate the visceral temperature. Upon arrival, all participants provided a urine sample for assessment of urine specific gravity as an indicator of their hydration status and they emptied their bladders before were weighed. They were weighed twice, at baseline and at the end of the match with a precision weight scale (Kern DE 150K2D, KERN \& SOHN GmbH, Balingen, Germany). During the match the participants consumed water and any other sport drink and food ad libitum. The total weight of the players' food and fluids that was consumed was measured using a precision weight scale. If participants wished to urinate during the match, they were asked to use a urine cup and their urine was weighed.
One hour before the match, the precooling group was wearing a Cooling Cap (WElkins Sideline Cooling System, SCS) for 45 minutes. On removal from a -20oC freezer, the cap surface was 10.7±2.5oC. After 45 minutes, participants removed the cap and they performed a 5 minutes standardized warm-up (running around the court and running exercises from baseline to net and back to baseline) and 10 min tennis specific warm up (rallies and serves) on court. Each participant, before the warm-up, was outfitted with a heart rate chest strap and iBUTTON sensors at four sites of the body (chest, upper arm, thigh and calf).
The scoring and timing characteristics of the matches complied with 2016 ITF rules. Three new balls were used for each match with the players retrieving balls between points. Matches were filmed from one end of the court, using a digital video camera (Sony DCR-VX2000E PAL, Japan). Participants were performed on perceptual measurements at baseline, after each set, and at the end of the match.
Thermoregulatory, cardiovascular and perceptual responses were recorded with standardized techniques: 1) visceral temperature using telemetric pill (BodyCap, Caen, France) was continuously recorded throughout the match; 2) skin temperature using iBUTTON sensors (type DS1921 H, Maxim/Dallas Semiconductor Corp., USA) on chest, upper arm, thigh and calf was recorded continuously; 3) heart rate (HR) variability data were sampled through short-range telemetry at 1,000 Hz with a Polar RS800CX (Polar Electro , Kempele, Finland). The heart rate monitor signal will be transferred to the Polar Precision Performance Software (release 3.00; Polar Electro Oy); 4) thermal comfort (scale 1-5), thermal sensation (scale 1-10) and rating of perceived exertion using standardized questionnaires were recorded at baseline, after each set, and at the end of the match.
Hydration status was recorded with urine specific gravity. All the collected urine samples will be analyzed using a refractrometer (Atago, Tokyo, Japan) for the determination of urine specific gravity. Euhydration will be defined as urine specific gravity <1.02 according to internationally accepted standards.
A digital video camera (Sony DCR-VX2000E PAL, Japan) was used to record the match - play characteristics. The footage was used to conduct the retrospective notational analysis. The quantitative performance indices that assessed had been: games and points won in each set and normalized to the number of games and points that record in each set respectively. Also unforced errors, first and second serve accuracy, aces, shots per rally and direction changes in each point calculated. Point's duration, between point-duration as well the effective point time calculated. The effective point time starting with the ball toss of the serve and ending when the ball passed the player or bounced twice on court. In case of double fault, starting time recorded from the beginning of the second serve.
Environmental data including air temperature, relative humidity, and wind speed were measured continuously using a portable weather station (Kestrel 5500FW Fire Weather Meter Pro, USA). The weather station was placed 1 meter above the ground according to the manufacturer's guidelines.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-cooling scenario | Experimental | Behavioral: Thermal stress and performance using a pre-cooling protocolOne hour before a tennis match, the pre-cooling group was wearing a Cooling Cap (WElkins Sideline Cooling System, SCS) for 45 minutes. |
| Sham evaluation | Sham comparator | Biological: Thermal stress and performance without a pre-cooling protocolParticipants were monitored during a usual game without any kind of pre-cooling strategy |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy adolescent athletes
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 |
|---|---|---|
| Thermal stress and performance using a pre-cooling protocolOne hour before a tennis match, participants were wearing a Cooling Cap (WElkins Sideline Cooling System, SCS) for 45 minutes. During the tennis match the following variables were monitored: heart rate, core temperature, skin temperature, thermal sensation and comfort, rating of perceived exertion and hydration status. | Behavioural | Pre-cooling scenario |
| Thermal stress and performance without a pre-cooling protocolDuring a tennis match the following variables were monitored: heart rate, core temperature, skin temperature, thermal sensation and comfort, rating of perceived exertion and hydration status. | Biological | Sham evaluation |
Primary outcome
Heart rate
Time frame: Up to 4 hours, during a one complete tennis match
Heart rate data were continuously monitored using a Polar Team system (Polar® Team 2, Polar Electro Oy, Kempele, Finland
Core temperature
Time frame: Up to 4 hours, during a one complete tennis match
Visceral temperature was continuously recorded throughout the match using telemetric pills (BodyCap, Caen, France)
Skin temperature
Time frame: Up to 4 hours, during a one complete tennis match
Skin temperature was continuously recorded throughout the match using iBUTTON sensors (type DS1921 H, Maxim/Dallas Semiconductor Corp., USA)
Change from baseline thermal comfort at after each set
Time frame: Change from baseline up to 1 hour after each set and up to 4 hours at the end of the match
Thermal comfort was assessed via the thermal comfort scale (1 = comfortable; 5 = extremely uncomfortable).
Change from baseline thermal sensation at after each set
Time frame: Change from baseline up to 1 hour after each set and up to 4 hours at the end of the match
Thermal sensation was assessed via the thermal sensation scale (-3 = cold; +3 = hot)
Change from baseline rating of perceived exertion at after each set
Time frame: Change from baseline up to 1 hour after each set and up to 4 hours at the end of the match
We used the Borg 20th Scale (6 = no exertion at all; 20 = maximal exertion)
Change from baseline urine specific gravity (hydration status) at the end of each match
Time frame: Change from baseline up to 4 hours at the end of the tennis match
Urine samples was obtained to evaluate the urine specific gravity. Urine specific gravity (single assessmentno units) was assessed using a refractometer (PAL-10S, ATAGO CO., LTD., Fukaya, Saitama Prefecture, Japan). Urine color was assessed using a urine color scale
Match - play characteristics (i.e., performance)
Time frame: Up to 4 hours, during a one complete tennis match
They were recorded by analyzing the video footage from the match. The quantitative performance indices assessed were: games and points won in each set and normalized to the number of games and points recorded in each set, respectively. Unforced errors, first and second serve accuracy, aces, shots per rally and direction changes in each point calculated. Point's duration, between point-duration as well the effective point time calculated. The effective point time starting with the ball toss of the serve and ending when the ball passed the player or bounced twice on court. In case of double fault, starting time recorded from the beginning of the second serve.
Air temperature
Time frame: Up to 4 hours, during a one complete tennis match
It was measured continuously using a portable weather station (Kestrel 5500FW Fire Weather Meter Pro, USA) placed 1 meter above the ground according to the manufacturer's
Relative humidity
Time frame: Up to 4 hours, during a one complete tennis match
It was measured continuously using a portable weather station (Kestrel 5500FW Fire Weather Meter Pro, USA) placed 1 meter above the ground according to the manufacturer's guidelines
Wind speed
Time frame: Up to 4 hours, during a one complete tennis match
It was measured continuously using a portable weather station (Kestrel 5500FW Fire Weather Meter Pro, USA) placed 1 meter above the ground according to the manufacturer's guidelines
Solar radiation
Time frame: Up to 4 hours, during a one complete tennis match
It was measured continuously using a portable weather station (Kestrel 5500FW Fire Weather Meter Pro, USA) placed 1 meter above the ground according to the manufacturer's guidelines. Solar radiation is measured directly by the device of portable weather station.
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 13 Dec 2019.
- Derived from this study: PubMed 34021093Misailidi M, Mantzios K, Papakonstantinou C, Ioannou LG, Flouris AD. Environmental and Psychophysical Heat Stress in Adolescent Tennis Athletes. Int J Sports Physiol Perform. 2021 Dec 1;16(12):1895-1900. doi: 10.1123/ijspp.2020-0820. Epub 2021 May 21.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermal stress and performance using a pre-cooling protocol and Thermal stress and performance without a pre-cooling protocol in people with Risk of Heat Stress, run by Petros Dinas at 1 site 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 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Heart rate (time frame: Up to 4 hours, during a one complete tennis match). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04197375, which also lists 1 linked publication.
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 13 Dec 2019.