UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029937 |
|---|---|
| Receipt number | R000034197 |
| Scientific Title | The physical and mental impacts of continuous one day bathing for 3 months in Ukiha hot spring |
| Date of disclosure of the study information | 2017/11/14 |
| Last modified on | 2017/11/12 15:11:01 |
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Basic information
Public title
The physical and mental impacts of continuous one day bathing for 3 months in Ukiha hot spring
Acronym
Ukina-Onsen bathing
Scientific Title
The physical and mental impacts of continuous one day bathing for 3 months in Ukiha hot spring
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Yausaki Goto |
Organization
Japan health and research institute
Division name
Research division
Zip code
Address
3-1-4 Nihonbashi, Chuo, Tokyo
TEL
81-3-5290-1621
ygoto@jph-ri.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yausaki Goto |
Organization
Japan health and research institute
Division name
Research Division
Zip code
Address
3-1-4 Nihonbashi, Chuo, Tokyo
TEL
81-3-5290-1621
Homepage URL
ygoto@jph-ri.or.jp
Sponsor or person
Institute
Japan health and research institute
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 10 | Month | 01 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034197
