UMIN-CTR Clinical Trial

Basic information
Public title	VR fitness and subjective evaluation of mind and body
Acronym	VR fitness and subjective evaluation of mind and body
Scientific Title	VR fitness and subjective evaluation of mind and body
Scientific Title:Acronym	VR fitness and subjective evaluation of mind and body
Region	Japan

Condition
Condition	healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Subjective evaluation of mind and body of hot spring area VR fitness
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	questionnaire
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	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	questionnaire
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy adults: fitness is not prohibited by doctors
Key exclusion criteria	Poor physical condition
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Yoshihide Middle name Last name Higuchi
Organization	Japan health and research institute
Division name	Onsen medical science research center
Zip code	103-0027
Address	Garou Building 8F 3-1-4 Nihonbashi Cyuou-ku,Tokyo
TEL	03-5290-1621
Email	y_higuchi@jph-ri.or.jp

Public contact
Name of contact person	1st name Yoshihide Middle name Last name Higuchi
Organization	Japan health and research institute
Division name	Onsen medical science research center
Zip code	103-0027
Address	Garou Building 8F 3-1-4 Nihonbashi Cyuou-ku,Tokyo
TEL	03-5290-1621
Homepage URL
Email	y_higuchi@jph-ri.or.jp

Sponsor
Institute	Japan health and research institute
Institute
Department

Funding Source
Organization	Japan Tourism Agency
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Japan health and research institute
Address	Garou Building 8F 3-1-4 Nihonbashi Cyuou-ku,Tokyo
Tel	03-5290-1621
Email	info@jph-ri.or.jp

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	2021 Year 02 Month 20 Day

Related information
URL releasing protocol
Publication of results	Unpublished

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	Preinitiation
Date of protocol fixation	2021 Year 01 Month 28 Day
Date of IRB
Anticipated trial start date	2021 Year 02 Month 10 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 02 Month 20 Day
Last modified on	2021 Year 02 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049550

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.