UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031614 |
|---|---|
| Receipt number | R000036088 |
| Scientific Title | Changes in body temperature and arterial blood flow rate of 42 degrees C bathing Comparison of a hot spring plunge bath and home bathtub bath |
| Date of disclosure of the study information | 2018/03/06 |
| Last modified on | 2018/03/06 21:06:16 |
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Basic information
Public title
Changes in body temperature and arterial blood flow rate of 42 degrees C bathing
Comparison of a hot spring plunge bath and home bathtub bath
Acronym
Changes in body temperature and arterial blood flow rate of 42 degrees C bathing
Scientific Title
Changes in body temperature and arterial blood flow rate of 42 degrees C bathing
Comparison of a hot spring plunge bath and home bathtub bath
Scientific Title:Acronym
Changes in body temperature and arterial blood flow rate of 42 degrees C bathing
Region
| Japan |
Condition
Condition
The subjects were 10 healthy adult men
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
One of the effects of the hot spring provides worm temperature. This effect raises temperature, and temperature control function operates and causes increase of the bloodstream. This time, these changes examined the thing by the size of the bathtub and the spring quality of the hot spring.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
They bathed for 10 min in bathtubs at 42 degrees C.
The enforcement used plunge bath (approximately 1,700 L: simple alkaline hot spring) and home bathtub (approximately 300 L: hot water, 0.1% artificially chlorinated spring). Measurement item of the maximum arterial blood flow rate, deep body temperatures.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
They bathed for 10 min in bathtubs at 42 degrees C.
plunge bath (approximately 1,700 L: simple alkaline hot spring) and home bathtub (approximately 300 L: hot water, 0.1% artificially chlorinated spring).
Three patterns were conducted on different days (within 1 to 2 weeks).
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
Healthy male
Key exclusion criteria
Not have serious underlying disease
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroya SHIMASAKI |
Organization
Oyamada Memorial Spa Hospital
Division name
tuusyo rehabilitation
Zip code
Address
5538-1, Yamada-Cho, Yokkaichi-City, Mie
TEL
059-328-1260
tuusyo-oya@syutaikai.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroya SHIMASAKI |
Organization
Oyamada Memorial Spa Hospital
Division name
tuusyo rehabilitation
Zip code
Address
5538-1, Yamada-Cho, Yokkaichi-City, Mie
TEL
059-328-1260
Homepage URL
tuusyo-oya@syutaikai.jp
Sponsor or person
Institute
Oyamada Memorial Spa Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Health & Research Institute
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 03 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2013 | Year | 08 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 19 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 06 | Day |
Last modified on
| 2018 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036088
