UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059211 |
|---|---|
| Receipt number | R000067724 |
| Scientific Title | Randomized controlled trial on the effects of sauna-induced passive heat exposure on the maintenance and decay of heat acclimation induced by short-term exercise in a hot environment |
| Date of disclosure of the study information | 2025/09/27 |
| Last modified on | 2025/09/26 23:12:52 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of sauna-induced passive heat exposure on the maintenance and decay of heat acclimation induced by short-term exercise in a hot environment
Acronym
Effects of sauna bathing on short-term heat acclimation
Scientific Title
Randomized controlled trial on the effects of sauna-induced passive heat exposure on the maintenance and decay of heat acclimation induced by short-term exercise in a hot environment
Scientific Title:Acronym
Trial on sauna bathing and short-term heat acclimation
Region
| Japan |
Condition
Condition
Endurance performance
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify how much passive heat exposure through regular sauna bathing contributes to the maintenance and decay of heat acclimation induced by 5 days of exercise.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sweat volume and core body temperature during the heat evaluation protocol
Key secondary outcomes
Heart rate, RPE, and sodium ion concentration in sweat during the heat acclimation evaluation protocol
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants in the intervention group will enter a designated sauna room at an ambient temperature of 80 to 90 degree celsius, three sets of 10 minutes each, six times over two weeks following heat acclimation. A 5 minute rest period will be provided between sets. During this period, prolonged heat exposure and vigorous exercise should be avoided.
Interventions/Control_2
Participants in the control group will be instructed to avoid prolonged heat exposure and vigorous exercise during the two weeks following heat acclimation.
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
| 39 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy male aged 18 to 39 years old
Key exclusion criteria
People with chronic diseases
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kumpei |
| Middle name | |
| Last name | Tanisawa |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama, Japan
TEL
0429476745
tanisawa@waseda.jp
Public contact
Name of contact person
| 1st name | Kumpei |
| Middle name | |
| Last name | Tanisawa |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama, Japan
TEL
0429476745
Homepage URL
tanisawa@waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Waseda University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Waseda University, Ethics Review Procedures concerning Research with Human Subjects
Address
1-104 Totsukacho, Shinjuku-ku, Tokyo 169-8050
Tel
0352721639
rinri@list.waseda.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 | 09 | Month | 27 | 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 | 29 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 30 | 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 | 09 | Month | 26 | Day |
Last modified on
| 2025 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067724
