UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043817 |
|---|---|
| Receipt number | R000050015 |
| Scientific Title | Longitudinal study of prevention, improvement and deterioration of frailty and pre-frailty |
| Date of disclosure of the study information | 2021/04/02 |
| Last modified on | 2021/04/02 13:45:15 |
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Basic information
Public title
Studies to clarify the factors of prevention, improvement and deterioration of frailty and pre-frailty
Acronym
Studies to clarify the factors of prefrail prevention
Scientific Title
Longitudinal study of prevention, improvement and deterioration of frailty and pre-frailty
Scientific Title:Acronym
Longitudinal study of prevention of pre-frailty
Region
| Japan |
Condition
Condition
pre-frailty
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the factors that influence the prevention, improvement and deterioration of frailty and pre-frailty in the elderly in the community in terms of social factors including physical factors and living functions.
Basic objectives2
Others
Basic objectives -Others
Elucidation of factors affecting the prevention, improvement and deterioration of pre-frailty in the elderly in the community
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevention, improvement and deterioration of pre-frailty
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
| 45 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
participation in annual measurement meetings held in the community
Key exclusion criteria
cannot participate in the annual measurement meeting
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | KOJI |
| Middle name | |
| Last name | YAMATSU |
Organization
Saga University
Division name
Faculty of Education
Zip code
8408502
Address
1 Honjyo-machi, Saga-city
TEL
0952-28-8302
kyamatsu@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | KOJI |
| Middle name | |
| Last name | YAMATSU |
Organization
Saga University
Division name
Faculty of Education
Zip code
8408502
Address
1 Honjyo-machi, Saga-city
TEL
0952-28-8302
Homepage URL
kyamatsu@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University
Institute
Department
Personal name
Funding Source
Organization
NPO Saga Prefecture CSO Promotion Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Education Research Ethics Committee, Saga University
Address
1 Honjyo-machi, Saga-city
Tel
0952-28-8302
kyamatsu@cc.saga-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 | 04 | Month | 02 | 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
| 2021 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Non
Management information
Registered date
| 2021 | Year | 04 | Month | 02 | Day |
Last modified on
| 2021 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050015
| Research Plan | |
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| 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 |
