UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Hiroya SHIMASAKI
Organization	Oyamada Memorial Spa Hospital
Division name	tuusyo rehabilitation
Address	5538-1, Yamada-Cho, Yokkaichi-City, Mie
TEL	059-328-1260
Email	tuusyo-oya@syutaikai.jp

Public contact
Name of contact person	Hiroya SHIMASAKI
Organization	Oyamada Memorial Spa Hospital
Division name	tuusyo rehabilitation
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 08 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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