UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059562 |
|---|---|
| Receipt number | R000068125 |
| Scientific Title | Study on heat acclimation by repeated hot water immersion |
| Date of disclosure of the study information | 2025/11/01 |
| Last modified on | 2025/11/01 11:46:28 |
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Basic information
Public title
Study on heat acclimation by repeated hot water immersion
Acronym
Study on heat acclimation by repeated hot water immersion
Scientific Title
Study on heat acclimation by repeated hot water immersion
Scientific Title:Acronym
Study on heat acclimation by repeated hot water immersion
Region
| Japan |
Condition
Condition
normal individual
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is thought that heat exposure, such as hot water exposure, improves sweating and vasodilatory function, but the extent to which hot water exposure in daily life affects these functions remains unclear. Therefore, the purpose of this study is to clarify the extent to which humans are acclimatized to heat through repeated hot water exposure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rectal temperature, ear temperature, sublingual temperature, skin temperature, heart rate, blood pressure, blood flow, sweat rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Repeat 20 minutes hot water immersion (40 degrees Celsius) for 5 days
Interventions/Control_2
Repeat 20 minutes hot showers (40 degrees Celsius) for 5 days
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
| 18 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who can voluntarily consent to participate in the study
Individuals who do not have heart disease, high blood pressure, and other cardiovascular disease.
Key exclusion criteria
Individuals who have heart disease, high blood pressure, and other cardiovascular disease.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Nishimura |
Organization
Kyushu University
Division name
Faculty of Design
Zip code
815-8540
Address
4-9-1 Shiobaru, Minamiku, Fukuoka, 815-8540, JAPAN
TEL
092-553-4433
nishimur@design.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Nishimura |
Organization
Kyushu University
Division name
Faculty of Design
Zip code
815-8540
Address
4-9-1 Shiobaru, Minamiku, Fukuoka, 815-8540, JAPAN
TEL
092-553-4433
Homepage URL
nishimur@design.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Takayuki Nishimura
Funding Source
Organization
Kyushu University
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu University Graduate School of Design Research Ethics Review Committee
Address
4-9-1 Shiobaru, Minamiku, Fukuoka, 815-8540, JAPAN
Tel
092-553-4429
gkskenkyo@jimu.kyushu-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
| 2025 | Year | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 28 | Day |
Last modified on
| 2025 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068125
