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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043817
Receipt No. 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

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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
Email 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
Email kyamatsu@cc.saga-u.ac.jp

Sponsor
Institute Saga University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050015

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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