UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The physical and mental impacts by bathing and exercise at "NAGAYU" kurhaus
Title of the study (Brief title)	"NAGAYU" kurhaus study
Region	Japan

Condition
Condition	Musculoskeletal pain
Classification by specialty	Medicine in general Psychosomatic Internal Medicine Surgery in general Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the impacts of bathing and exercise at "Nagayu" kurhaus
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	motor function
Key secondary outcomes	Body measurements, Blood pressure, Subjective health (Visual analogue scale)

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	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	5days bathing and exercise at "Nagayu" kurhaus
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Healthy adults
Key exclusion criteria	Who can not exercise and bathing
Target sample size	20

Research contact person
Name of lead principal investigator	Yasuaki Goto
Organization	Japan Health & Research Institute
Division name	Health Tourism Institute
Address	3-1-4 Nihonbashi Chuo-ku Tokyo Japan
TEL	+81-3-5390-1625
Email	y_goto422@j-medical-healthcare.com

Public contact
Name of contact person	Yasuaki Goto
Organization	Japan Health & Research Institute
Division name	Health Tourism Institute
Address	3-1-4 Nihonbashi Chuo-ku Tokyo Japan
TEL	+81-3-5390-1625
Homepage URL
Email	y_goto422@j-medical-healthcare.com

Sponsor
Institute	Japan Health & Research Institute
Institute
Department

Funding Source
Organization	Taketa City
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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	長湯温泉クアハウス

Other administrative information
Date of disclosure of the study information	2019 Year 01 Month 27 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 12 Month 10 Day
Anticipated trial start date	2019 Year 01 Month 28 Day
Last follow-up date	2019 Year 02 Month 28 Day
Date of closure to data entry	2019 Year 02 Month 28 Day
Date trial data considered complete	2019 Year 02 Month 28 Day
Date analysis concluded	2019 Year 03 Month 31 Day

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

Management information
Registered date	2019 Year 01 Month 27 Day
Last modified on	2019 Year 01 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040644