UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054829 |
|---|---|
| Receipt number | R000062405 |
| Scientific Title | Development and effectiveness verification of new frailty prevention activities in which the elderly and young people work together to learn about frailty |
| Date of disclosure of the study information | 2024/07/01 |
| Last modified on | 2026/02/20 15:12:39 |
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Basic information
Public title
Development and effectiveness verification of new frailty prevention activities in which the elderly and young people work together to learn about frailty
-Application of IT-based intergenerational exchange and regional frailty prevention diagnosis-
Acronym
Development and effectiveness verification of new frailty prevention activities in which the elderly and young people work together to learn about frailty
Scientific Title
Development and effectiveness verification of new frailty prevention activities in which the elderly and young people work together to learn about frailty
Scientific Title:Acronym
Development and effectiveness verification of new frailty prevention activities in which the elderly and young people work together to learn about frailty
Region
| Japan |
Condition
Condition
community dwelling older people, university students
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development and evaluation of new frailty prevention activities using community diagnosis, self-analysis, and intergenerational exchange
Basic objectives2
Others
Basic objectives -Others
Development of program
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective perception of frailty through questionnaire survey and interest in frailty prevention activities, etc. are compared between base line and post program.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
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
Frailty prevention education
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Elderly groups and student volunteers who agree with the purpose of this study (in principle, those who wish to participate in all five sessions of the program)
Key exclusion criteria
No specific physical conditions are required, but those who find it difficult to participate in the program for mental/psychological reasons will be excluded.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Kera |
Organization
Takasaki University of Health and Welfare
Division name
Department of Physical Therapy
Zip code
370-0033
Address
501 Nakaorui-machi, Takasaki-shi, Gunma 370-0033, Japan
TEL
027-352-1291
kera@takasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Kera |
Organization
Takasaki University of Healt and Welfare
Division name
Department of Physical Therapy
Zip code
370-0033
Address
501 Nakaorui-machi, Takasaki-shi, Gunma, Japan
TEL
027-352-1291
Homepage URL
kera@takasaki-u.ac.jp
Sponsor or person
Institute
Takasaki University of Healt and Welfare
Institute
Department
Personal name
Takeshi Kera
Funding Source
Organization
Gunma Health Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Takasaki University of Healt and Welfare
Address
501 Nakaorui-machi, Takasaki-shi, Gunma, Japan
Tel
027-352-1291
kera@takasaki-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
| 2024 | Year | 07 | Month | 01 | 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
11
Results
All subjects completed the program. Basic knowledge related to frailty prevention improved significantly in all areas. Regarding the community and frailty prevention, understanding of education, welfare services, information gathering, and costs also improved significantly. Attitudes toward the community and self-efficacy regarding health management also improved significantly.
Results date posted
| 2026 | Year | 02 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The participants were elderly residents of the M district of Maebashi City, Gunma Prefecture, comprising seven men (77.9 +/- 7.3 years) and four women (79.8 +/- 5.6 years), all of whom were able to walk from their homes to the venue. The student group consisted of three medical and welfare university students (all first-year females) who agreed to participate.
Participant flow
Residents of the M district of Maebashi City, Gunma Prefecture were invited to participate through the local community welfare officer.
Adverse events
There were no adverse events.
Outcome measures
Questions assessing understanding of frailty, the community, and frailty prevention; a scale measuring attitudes toward the community; and a health-related self-efficacy scale.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2025 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 01 | Day |
Last modified on
| 2026 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062405
