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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031614
Receipt No. 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

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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
Email 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
Email tuusyo-oya@syutaikai.jp

Sponsor
Institute Oyamada Memorial Spa Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036088

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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