UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061050 |
|---|---|
| Receipt number | R000069794 |
| Scientific Title | Effects of body-cooling recovery during golf play on core body temperature in a hot environment: a crossover study |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/05/19 12:33:49 |
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Basic information
Public title
Effects of body-cooling recovery during golf play on core body temperature
Acronym
GOLF-COOL Study
Scientific Title
Effects of body-cooling recovery during golf play on core body temperature in a hot environment: a crossover study
Scientific Title:Acronym
GOLF-COOL Core trial
Region
| Japan |
Condition
Condition
Heat stress during exercise
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether body-cooling recovery during golf play attenuates the increase in core body temperature.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes and differences in core body temperature between cooling and non-cooling conditions during golf play, measured continuously using an ingestible telemetric temperature sensor.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Cooling
Interventions/Control_2
Control
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 30 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male
Key inclusion criteria
1.Individuals aged 30 to 75 years who have received a full explanation of the study objectives and procedures, have understood the content, and have provided written informed consent voluntarily.
2. Male participants who are golf course users.
Key exclusion criteria
1.Individuals who have been advised by a physician to restrict physical activity, or those for whom exercise may worsen their medical condition.
2.Individuals with serious cardiovascular diseases (e.g., unstable angina, recent myocardial infarction), severe arrhythmias, or a history of cerebrovascular disease that may affect safety.
3.Individuals with severe respiratory or renal diseases, or any other condition that may interfere with the conduct of the study.
4.Individuals who are deemed inappropriate for participation by the principal investigator for safety or other reasons.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yasuki |
| Middle name | |
| Last name | Higaki |
Organization
Fukuoka University
Division name
Faculty of Sports and Health Science
Zip code
814-0180
Address
Nanakuma 8-19-1,Jonan-ku, Fukuoka
TEL
0928716631
higaki@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Rie |
| Middle name | |
| Last name | Tomiga |
Organization
Fukuoka university
Division name
Faculty of Sports and Health Science
Zip code
814-0180
Address
Nanakuma 8-19-1,Jonan-ku, Fukuoka
TEL
0928716631
Homepage URL
lrietty.tl@gmail.com
Sponsor or person
Institute
Fukuoka university
Institute
Department
Personal name
Funding Source
Organization
Kitakyushu Power Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka Univ. Department of Bioethics & Medical Ethics
Address
Nanakuma 8-19-1,Jonan-ku, Fukuoka
Tel
092-801-1011 (Ext. 3193)
fumed-ethics@fukuoka-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 25 | Day |
Last modified on
| 2026 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069794
