UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058471 |
|---|---|
| Receipt number | R000066719 |
| Scientific Title | Examination of the effects of sauna bathing time on thermoregulatory function, autonomic function, and dehydration. |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/07/15 12:30:15 |
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Basic information
Public title
sauna bathing study
Acronym
sauna bathing study
Scientific Title
Examination of the effects of sauna bathing time on thermoregulatory function, autonomic function, and dehydration.
Scientific Title:Acronym
Examination of the effects of sauna bathing time on thermoregulatory function, autonomic function, and dehydration.
Region
| Japan |
Condition
Condition
kidney disease
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effects of sauna bathing time on thermoregulatory, autonomic function and dehydration.
Basic objectives2
Others
Basic objectives -Others
Effectiveness of sauna bathing
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The comparison of the changes in urinary osmolality concentrations from before sauna bathing to immediately after sauna bathing and after 60 minutes.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
sauna bathing (10 minutes)
Interventions/Control_2
sauna bathing (20 minutes)
Interventions/Control_3
sauna bathing (30 minutes)
Interventions/Control_4
Control (no sauna)
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
| 39 | years-old | >= |
Gender
Male
Key inclusion criteria
1. persons with relatively preserved renal function
2. adult male over 18 years old who have been fully informed of the purpose and content of this study and who have given their consent in writing of their own free will based on a thorough understanding of the purpose and content of the research
Key exclusion criteria
1. persons who suffer from specific underlying diseases or a history of associated symptoms
2. persons taking medications that affect systemic hemodynamics
3. other persons deemed unsuitable by the principal investigator
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Ryoma |
| Middle name | |
| Last name | Michishita |
Organization
Fukuoka University
Division name
Faculty of Sports and Health Science
Zip code
814-0180
Address
8-19-1 Nanakuma, Johnan-ku, Fukuoka, Fukuoka, Japan
TEL
092-871-6631
rmichishita@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Shotaro |
| Middle name | |
| Last name | Kawakami |
Organization
Toyama Prefectural University
Division name
Faculty of Engineering
Zip code
939-0398
Address
5180 Kurokawa, Imizu, Toyama, Japan
TEL
0766-56-7500
Homepage URL
skawakami@pu-toyama.ac.jp
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Fukuoka University
Address
7-45-1 Nanakuma, Johnan-ku, Fukuoka, Fukuoka, Japan
Tel
092-801-1011
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
| 2025 | Year | 08 | 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
| 2025 | Year | 07 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | 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 | 07 | Month | 15 | Day |
Last modified on
| 2025 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066719
