UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044271 |
|---|---|
| Receipt number | R000050541 |
| Scientific Title | Community intervention research of health promotion for the elderly |
| Date of disclosure of the study information | 2021/05/20 |
| Last modified on | 2021/05/20 14:45:36 |
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Basic information
Public title
Community intervention research of health promotion for the elderly
Acronym
Community intervention research of health promotion for the elderly
Scientific Title
Community intervention research of health promotion for the elderly
Scientific Title:Acronym
Community intervention research of health promotion for the elderly
Region
| Japan |
Condition
Condition
elderly
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Search for biomarkers related to dementia, frailty syndrome, and age-related diseases in the elderly
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Biomarker after 18 months
Key secondary outcomes
MMSE
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Weekly exercise, diet, cognitive training
Interventions/Control_2
Daily yogurt intake
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
| 75 | years-old | <= |
Age-upper limit
| 83 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Residents living at home in the Ajisu area
Key exclusion criteria
MMSE Less than 23
Residents who are certified as requiring nursing care 2 or more
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Tanabe |
Organization
Yamaguchi University Faculty of Medicine and Health Sciences
Division name
Public health
Zip code
755-8505
Address
1-1-1 Minamikogushi, Ube, Yamaguchi
TEL
0836-22-2231
tanabe@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryosuke |
| Middle name | |
| Last name | Hase |
Organization
Yamaguchi University Faculty of Medicine and Health Sciences
Division name
Public health
Zip code
755-8505
Address
1-1-1 Minamikogushi, Ube, Yamaguchi
TEL
0836-22-2231
Homepage URL
ryosuke-hase@umin.ac.jp
Sponsor or person
Institute
Yamaguchi University
Institute
Department
Personal name
Funding Source
Organization
Self-procurement
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center For Clinical Research, Yamaguchi University Hospital
Address
1-1-1 Minamikogushi, Ube, Yamaguchi
Tel
0836-22-2428
me223@yamaguchi-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
| 2021 | Year | 05 | 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
101
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 24 | Day |
Last follow-up date
| 2023 | 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 | 05 | Month | 20 | Day |
Last modified on
| 2021 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050541
| 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 |
