UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032131 |
|---|---|
| Receipt number | R000036657 |
| Scientific Title | Effect verification test of Kao's walking support system introducing to Hokusei Transport Corporation(taxi company in Hirosaki City, Aomori Prefecture) for the purpose of promoting employee health(2018). |
| Date of disclosure of the study information | 2018/04/09 |
| Last modified on | 2018/10/09 16:09:15 |
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Basic information
Public title
Effect verification test of Kao's walking support system introducing to Hokusei Transport Corporation(taxi company in Hirosaki City, Aomori Prefecture) for the purpose of promoting employee health(2018).
Acronym
Effect verification test of walking support system
Scientific Title
Effect verification test of Kao's walking support system introducing to Hokusei Transport Corporation(taxi company in Hirosaki City, Aomori Prefecture) for the purpose of promoting employee health(2018).
Scientific Title:Acronym
Effect verification test of walking support system
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of the effect of walking support system
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Walking habits in daily life (number of steps, walking speed) and walking measurement, visceral fat measurement
Key secondary outcomes
Physical examination, rise test, health consciousness, QOL survey
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
-Activity meter (3 months during the test period)
-Walking habit feedback (once a month)
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 Adult
-Those who are regular life
-The person who can attach an activity meter to the waist
Key exclusion criteria
-Those who have difficulty walking normally body
-Those Who pacemakers is in the body
-Pregnant women
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeyuki Nakaji |
Organization
Hirosaki University
Division name
Gradute School of Medicine
Zip code
Address
5, Zuifu-cho, Hirosaki-shi, Aomori-ken, 036-8592, JAPAN
TEL
0172-39-5041
nakaji@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kouichi Wakabayashi |
Organization
Hirosaki University
Division name
Gradute School of Medicine
Zip code
Address
5, Zuifu-cho, Hirosaki-shi, Aomori-ken, 036-8592, JAPAN
TEL
0172-39-5194
Homepage URL
Wakabayashi@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University
Institute
Department
Personal name
Funding Source
Organization
Kao corporation
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kao corporation
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
北星交通株式会社（青森県）、弘前大学（青森県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 09 | 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
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 17 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 27 | Day |
Date of closure to data entry
| 2018 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 06 | Day |
Last modified on
| 2018 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036657
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
