UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051956 |
|---|---|
| Receipt number | R000059299 |
| Scientific Title | Research for constructing health education system -Results and evaluation of health education- |
| Date of disclosure of the study information | 2023/08/21 |
| Last modified on | 2023/08/20 23:45:36 |
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Basic information
Public title
Research for constructing health education system -Results and evaluation of health education-
Acronym
Research for constructing health education system -Results and evaluation of health education-
Scientific Title
Research for constructing health education system -Results and evaluation of health education-
Scientific Title:Acronym
Research for constructing health education system -Results and evaluation of health education-
Region
| Japan |
Condition
Condition
able-bodied person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, health education will be conducted by the medical corporation Yuaikai and Minowa Town, and data will be analyzed for test/measurement items and step counts at Shinshu University, and the results of the analysis will be reported. Yuaikai and Minowa Town will provide guidance to improve the health level of health education participants, including prevention of dementia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pedometers will be distributed, health education including health lectures and practical skills will be provided once or twice a month, and the goal will be to walk 7,000 steps a day. Morphological measurements, physical fitness measurements, brain function measurements (go/no-go tasks), and blood tests will be performed before and after that to evaluate the improvement in health level.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 12 | months-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants who wish to participate in this study and who will participate.
Key exclusion criteria
Participants were excluded if they were unable to walk indoors without assistance for at least three minutes, had neurological disorders, had orthopedic surgery within the last two years, had a history of stroke or psychiatric disorders, or were unable to understand the instructions.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Terasawa |
Organization
Shinshu University
Division name
Faculty of Education
Zip code
380-8544
Address
6-Ro, Nishinagano, Nagano City, Nagano Prefecture
TEL
026-238-4213
kterasa@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Terasawa |
Organization
Shinshu University
Division name
Faculty of Education
Zip code
380-8544
Address
6-Ro, Nishinagano, Nagano City, Nagano Prefecture
TEL
026-238-4213
Homepage URL
kterasa@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Shinshu University
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University
Address
6-Ro, Nishinagano, Nagano City, Nagano Prefecture
Tel
026-238-4213
kterasa@shinshu-u.ac.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
| 2023 | Year | 08 | Month | 21 | 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
| 2023 | Year | 09 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2028 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 08 | Month | 20 | Day |
Last modified on
| 2023 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059299
