UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038539 |
|---|---|
| Receipt number | R000043896 |
| Scientific Title | The physical and mental impacts by Urabandai walking |
| Date of disclosure of the study information | 2019/11/11 |
| Last modified on | 2019/11/11 13:39:12 |
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Basic information
Public title
The physical and mental impacts by Urabandai walking
Acronym
Urabandai walking
Scientific Title
The physical and mental impacts by Urabandai walking
Scientific Title:Acronym
Urabandai walking
Region
| Japan |
Condition
Condition
Mental disorder
Classification by specialty
| Psychosomatic Internal Medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the impacts of Urabandai walking program
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salivary amylase before and after intervention
Key secondary outcomes
Profile of Mood Statss(POMS2 short version), Self Efficacy(GSES), Subjective status (Visual analog Scale) 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
NO
Dynamic allocation
YES
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
Urabandai Walking program
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy Adults
Key exclusion criteria
Who prohibited exercise
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hirokazu |
| Middle name | |
| Last name | Sabane |
Organization
JTB
Division name
Sendai branch
Zip code
980-0804
Address
1-4-1 Omachi, Aobaku, Sendai city, Miyagi
TEL
022-263-6712
h_sabane217@jtb.com
Public contact
Name of contact person
| 1st name | Hirokazu |
| Middle name | |
| Last name | Sabane |
Organization
JTB
Division name
Sendai Branch
Zip code
980-0804
Address
1-4-1 Omachi, Aobaku, Sendai city, Miyagi
TEL
022-263-6712
Homepage URL
h_sabane217@jtb.com
Sponsor or person
Institute
JTB Sendai Branch
Institute
Department
Personal name
Funding Source
Organization
Kitashiobara village
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Health & Research Institute
Address
3-1-4 Nihonbashi, Chuo, Tokyo
Tel
03-5290-1621
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
| 2019 | Year | 11 | Month | 11 | 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
| 2020 | Year | 06 | Month | 20 | Day |
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
| 2018 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 01 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 11 | Day |
Last modified on
| 2019 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043896
