Decline, CognitiveNCT05068804
Intermittent Cooling During Baseball Games on Hitting and Defense Performance
A study testing Cooling in people with Decline, Cognitive, run by National Taiwan Sport University at 1 site in Taiwan.
Trial summary
This study adopted a practical approach in intermittent cooling on forehead and neck during an intra-squad baseball game. Exit velocity of batted balls was used as an indicator for hitting performance and a baseball-specific reactive agility test to evaluate the cognitive performance in defense. Read more about this study
- Who is it for?
- Ages 20 to 23 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Decline, Cognitive
- What is being tested?
- Cooling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Jul 2020to 10 Sep 2020
- 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 20 to 23 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- baseball players from National Taiwan University of Sport, Taiwan
- at least 6 years of experience in baseball training
- have competed nationally.
Who cannot join
- having cardiovascular or other known chronic diseases
- taking any medication in the preceding 2 months
- having musculoskeletal injuries in the preceding 2 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intermittent Cooling During Baseball Games Alleviated Perceived Exertion But Had no Effect on Hitting and Defense Performance in Hot Environment
This study adopted a practical approach in intermittent cooling on forehead and neck during an intra-squad baseball game. Exit velocity of batted balls was used as an indicator for hitting performance and a baseball-specific reactive agility test to evaluate the cognitive performance in defense.
Read the detailed description
This study used a randomized cross-over design. Each participant completed a cooling and a non-cooling trial in a random order, separated by a 20-day washout period. Each trial contained a 7-inning intra-squad game in hot environment. Hitting, reactive agility, and cognitive tests were administered before and after the game. Forehead skin and tympanic temperature, perceived exertion, and thermal sensation were measured during the game.
Experimental procedure After body weight and rectal temperature were measured in a temperature-controlled room, the participants consumed a standardized breakfast. The breakfast included white bread 1.2 g/kg, jam 0.1 g/kg, butter 0.l g/kg, and soybean milk 5 ml/kg (6.2 kcal/kg, containing carbohydrate 1.0 g/kg, protein 0.24 g/kg, and fat 0.14 g/kg). Go/NoGo and Stroop Color-Word tasks were administered after breakfast. After finishing the cognitive tests, the participants moved to the field for self-selected warm up, followed by hitting and reactive agility tests. After the intra-squad game, the participants repeated the hitting, reactive agility, and cognitive tests. The participants can drink water ad libitum during the experimental period.
Intra-squad game The 7-inning intra-squad games were played under the standard rules of baseball in hot environmental conditions (temperature 31.1-33.4℃, humidity 63-67%).
Cooling intervention The participants in the cooling trial put cold towels on their forehead and neck for 3 min in the shaded dugout during their offensive half innings when they were not scheduled to hit or on base. Each participant received the cooling intervention 3 to 4 times in each game. After each use, the towels were kept in a cooler that contained water mixed with ice and salt to keep the temperature at approximately 0℃. The participants in the control trial sat in the shaded dugout without any cooling intervention.
Measurement of temperature Rectal temperature was measured before breakfast and after the game with a digital thermometer fitted with disposable sheaths. Forehead skin and tympanic temperature were measured with infrared thermometers during their offensive half innings in the dugout.
Hitting test The participants used their own bat to hit balls thrown by a pitching machine positioned 12 m from the home plate. The ball speed was approximately 120 km/h. The participants were asked to make the best effort to hit the balls. Each test was consisted of 15 batted balls. Exit velocity was measured with a video system and swing power was measured with a sensor attached to the knob of the bat.
Reactive agility test The infielders played defense against ground balls at the short stop position while the outfielders played defense against fly balls in center field. The participants were asked to move toward the ball as soon as they determine the trajectory and make the best effort to catch it. Each test was consisted of 15 batted balls. The reaction time, the time from bat-ball contact to the participant's first definitive movement in the intended direction, was calculated post-hoc using frame-by-frame analysis of the video footage by an experienced coach
Cognitive tests The Go/NoGo and Stroop Color-Word tasks were administered on a laptop computer in a quiet room. Each task contained 100 trials.
Perceived exertion and thermal sensation The participants reported their perceived exertion and thermal sensation during their offensive half innings. Perceived exertion was estimated with a 10-point Borg scale. Thermal sensation was estimated with a 7-point scale from -3 being the coolest to 3 being the hottest.
- Conditions
- Decline, Cognitive
- Being tested
- Cooling, control
- Keywords
- baseball, cognitive, cooling
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoolingProcedure or surgery
The participants in the cooling trial put cold towels on their forehead and neck for 3 min in the shaded dugout during their offensive half innings when they were not scheduled to hit or on base. Each participant received the cooling intervention 3 to 4 times in each game. After each use, the towels were kept in a cooler that contained water mixed with ice and salt to keep the temperature at approximately 0℃.
controlOther
The participants in the control trial sat in the shaded dugout without any cooling intervention.
| Study group | Role | What they receive |
|---|---|---|
| cooling | Experimental | The participants in the cooling trial put cold towels on their forehead and neck for 3 min in the shaded dugout during their offensive half innings when they were not scheduled to hit or on base. Each participant received the cooling intervention 3 to 4 times in each game. After each use, the towels were kept in a cooler that contained water mixed with ice and salt to keep the temperature at approximately 0℃. Receives: Procedure: Cooling |
| Control | Placebo comparator | The participants in the control trial sat in the shaded dugout without any cooling intervention. Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
rectal temperature
Measured: baseline
change in rectal temperature
Measured: 5 hours after the baseline
forehead skin temperature
Measured: baseline
change in forehead skin temperature
measured after each inning in an 2-hour 7-inning intra-squad baseball game
Measured: 2 hours after the baseline
tympanic temperature
Measured: baseline
change in tympanic temperature
measured after each inning in an 2-hour 7-inning intra-squad baseball game
Measured: 2 hours after the baseline
exit velocity of batted balls
Measured: baseline
change in exit velocity of batted balls
Measured: 3 hours after baseline
reactive agility in defense
The reaction time, the time from bat-ball contact to the participant's first definitive movement in the intended direction
Measured: baseline
change in reactive agility in defense
The reaction time, the time from bat-ball contact to the participant's first definitive movement in the intended direction
Measured: 3 hours after baseline
swing power
power of bat swings
Measured: baseline
change in swing power
power of bat swings
Measured: 3 hours after baseline
Secondary outcomes (8)
ratings of perceived exertion
Measured: baseline
change in ratings of perceived exertion
measured after each inning in an 2-hour 7-inning intra-squad baseball game
Measured: 2 hours after baseline
thermal sensation
Measured: baseline
change in thermal sensation
measured after each inning in an 2-hour 7-inning intra-squad baseball game
Measured: 2 hours after baseline
Go/NoGo tasks
reaction time and error rate
Measured: baseline
change in Go/NoGo tasks
reaction time and error rate
Measured: 5 hours after baseline
Stroop Color-Word test
reaction time and error rate
Measured: baseline
change in Stroop Color-Word test
reaction time and error rate
Measured: 5 hours after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start15 Jul 2020
- Primary completion10 Sep 2020
- Study completion10 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decline, CognitiveStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan Sport University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Principal investigator, Chen Kang, National Taiwan Sport University
- Investigators
- Chen-Kang Chang, Principal investigator, National Taiwan University of Sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068804
- Sponsor's protocol ID
- 18-076-A
- Status last verified
- Sep 2021
- First submitted
- 6 Sep 2021
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Cooling During Baseball Games Alleviated Perceived Exertion But Had no Effect on Hitting and Defense Performance in Hot Environment
- ClinicalTrials.gov ID
- NCT05068804
- Acronym / sponsor ID
- 18-076-A
- Conditions
- Decline, Cognitive
- Keywords
- baseball, cognitive, cooling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- National Taiwan Sport UniversityUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 10 Sep 2020 (actual)
- Study completion
- 10 Sep 2020 (actual)
- First posted
- 6 Oct 2021 (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.
This study adopted a practical approach in intermittent cooling on forehead and neck during an intra-squad baseball game. Exit velocity of batted balls was used as an indicator for hitting performance and a baseball-specific reactive agility test to evaluate the cognitive performance in defense.
Detailed description
This study used a randomized cross-over design. Each participant completed a cooling and a non-cooling trial in a random order, separated by a 20-day washout period. Each trial contained a 7-inning intra-squad game in hot environment. Hitting, reactive agility, and cognitive tests were administered before and after the game. Forehead skin and tympanic temperature, perceived exertion, and thermal sensation were measured during the game.
Experimental procedure After body weight and rectal temperature were measured in a temperature-controlled room, the participants consumed a standardized breakfast. The breakfast included white bread 1.2 g/kg, jam 0.1 g/kg, butter 0.l g/kg, and soybean milk 5 ml/kg (6.2 kcal/kg, containing carbohydrate 1.0 g/kg, protein 0.24 g/kg, and fat 0.14 g/kg). Go/NoGo and Stroop Color-Word tasks were administered after breakfast. After finishing the cognitive tests, the participants moved to the field for self-selected warm up, followed by hitting and reactive agility tests. After the intra-squad game, the participants repeated the hitting, reactive agility, and cognitive tests. The participants can drink water ad libitum during the experimental period.
Intra-squad game The 7-inning intra-squad games were played under the standard rules of baseball in hot environmental conditions (temperature 31.1-33.4℃, humidity 63-67%).
Cooling intervention The participants in the cooling trial put cold towels on their forehead and neck for 3 min in the shaded dugout during their offensive half innings when they were not scheduled to hit or on base. Each participant received the cooling intervention 3 to 4 times in each game. After each use, the towels were kept in a cooler that contained water mixed with ice and salt to keep the temperature at approximately 0℃. The participants in the control trial sat in the shaded dugout without any cooling intervention.
Measurement of temperature Rectal temperature was measured before breakfast and after the game with a digital thermometer fitted with disposable sheaths. Forehead skin and tympanic temperature were measured with infrared thermometers during their offensive half innings in the dugout.
Hitting test The participants used their own bat to hit balls thrown by a pitching machine positioned 12 m from the home plate. The ball speed was approximately 120 km/h. The participants were asked to make the best effort to hit the balls. Each test was consisted of 15 batted balls. Exit velocity was measured with a video system and swing power was measured with a sensor attached to the knob of the bat.
Reactive agility test The infielders played defense against ground balls at the short stop position while the outfielders played defense against fly balls in center field. The participants were asked to move toward the ball as soon as they determine the trajectory and make the best effort to catch it. Each test was consisted of 15 batted balls. The reaction time, the time from bat-ball contact to the participant's first definitive movement in the intended direction, was calculated post-hoc using frame-by-frame analysis of the video footage by an experienced coach
Cognitive tests The Go/NoGo and Stroop Color-Word tasks were administered on a laptop computer in a quiet room. Each task contained 100 trials.
Perceived exertion and thermal sensation The participants reported their perceived exertion and thermal sensation during their offensive half innings. Perceived exertion was estimated with a 10-point Borg scale. Thermal sensation was estimated with a 7-point scale from -3 being the coolest to 3 being the hottest.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cooling | Experimental | Procedure: CoolingThe participants in the cooling trial put cold towels on their forehead and neck for 3 min in the shaded dugout during their offensive half innings when they were not scheduled to hit or on base. Each participant received the cooling intervention 3 to 4 times in each game. After each use, the towels were kept in a cooler that contained water mixed with ice and salt to keep the temperature at approximately 0℃. |
| Control | Placebo comparator | Other: controlThe participants in the control trial sat in the shaded dugout without any cooling intervention. |
Who may qualify
- Ages
- 20 to 23 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- baseball players from National Taiwan University of Sport, Taiwan
- at least 6 years of experience in baseball training
- have competed nationally.
Key exclusion criteria (3 listed)
- having cardiovascular or other known chronic diseases
- taking any medication in the preceding 2 months
- having musculoskeletal injuries in the preceding 2 months.
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 |
|---|---|---|
| CoolingThe participants in the cooling trial put cold towels on their forehead and neck for 3 min in the shaded dugout during their offensive half innings when they were not scheduled to hit or on base. Each participant received the cooling intervention 3 to 4 times in each game. After each use, the towels were kept in a cooler that contained water mixed with ice and salt to keep the temperature at approximately 0℃. | Procedure or surgery | cooling |
| controlThe participants in the control trial sat in the shaded dugout without any cooling intervention. | Other | Control |
Primary outcome
rectal temperature
Time frame: baseline
change in rectal temperature
Time frame: 5 hours after the baseline
forehead skin temperature
Time frame: baseline
change in forehead skin temperature
Time frame: 2 hours after the baseline
measured after each inning in an 2-hour 7-inning intra-squad baseball game
tympanic temperature
Time frame: baseline
change in tympanic temperature
Time frame: 2 hours after the baseline
measured after each inning in an 2-hour 7-inning intra-squad baseball game
exit velocity of batted balls
Time frame: baseline
change in exit velocity of batted balls
Time frame: 3 hours after baseline
reactive agility in defense
Time frame: baseline
The reaction time, the time from bat-ball contact to the participant's first definitive movement in the intended direction
change in reactive agility in defense
Time frame: 3 hours after baseline
The reaction time, the time from bat-ball contact to the participant's first definitive movement in the intended direction
swing power
Time frame: baseline
power of bat swings
change in swing power
Time frame: 3 hours after baseline
power of bat swings
8 secondary outcomes
ratings of perceived exertion
Time frame: baseline
change in ratings of perceived exertion
Time frame: 2 hours after baseline
thermal sensation
Time frame: baseline
change in thermal sensation
Time frame: 2 hours after baseline
Go/NoGo tasks
Time frame: baseline
change in Go/NoGo tasks
Time frame: 5 hours after baseline
Stroop Color-Word test
Time frame: baseline
change in Stroop Color-Word test
Time frame: 5 hours after baseline
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 6 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Chen-Kang Chang principal investigator
National Taiwan University of Sport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cooling in people with Decline, Cognitive, run by National Taiwan Sport University at 1 site in Taiwan.
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 3 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 6 Oct 2021. 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 Taiwan. 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?
rectal temperature (time frame: baseline). 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?
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 6 Oct 2021.