UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The physical and mental impacts of continuous one day bathing for 3 months in Ukiha hot spring
Title of the study (Brief title)	Ukina-Onsen bathing
Region	Japan

Condition
Condition	Life habits related diseases
Classification by specialty	Medicine in general Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the impacts of 2days batihng per a week in hot spring of Ukiha city
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	SF-8, POMS and Self effocacy before and after 3 months intervention
Key secondary outcomes	2 step test, functional reach, bend forward, body measurements (Height, Weight, BMI, Waist circumference), Accelerated photoplethysmography, PWV, Blood pressure, Heart rate valiability, Salivary amylase,muscle hardness, skin condition, blood examination(general items, d-ROM, BAP) before and after intervention

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Behavior,custom Other
Interventions/Control_1	Bathing in hot spring of Ukiha city (2times a week for 3 months)
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	74 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy adults
Key exclusion criteria	People under a medical care for hypertension
Target sample size	40

Research contact person
Name of lead principal investigator	Yausaki Goto
Organization	Japan health and research institute
Division name	Research division
Address	3-1-4 Nihonbashi, Chuo, Tokyo
TEL	81-3-5290-1621
Email	ygoto@jph-ri.or.jp

Public contact
Name of contact person	Yausaki Goto
Organization	Japan health and research institute
Division name	Research Division
Address	3-1-4 Nihonbashi, Chuo, Tokyo
TEL	81-3-5290-1621
Homepage URL
Email	ygoto@jph-ri.or.jp

Sponsor
Institute	Japan health and research institute
Institute
Department

Funding Source
Organization	Ukiha City
Organization
Division
Category of Funding Organization	Local Government
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	2017 Year 11 Month 14 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 10 Month 01 Day
Anticipated trial start date	2017 Year 11 Month 14 Day
Last follow-up date	2018 Year 03 Month 01 Day
Date of closure to data entry	2018 Year 03 Month 01 Day
Date trial data considered complete	2018 Year 03 Month 01 Day
Date analysis concluded	2020 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 11 Month 12 Day
Last modified on	2017 Year 11 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034197