UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058878 |
|---|---|
| Receipt number | R000067326 |
| Scientific Title | Study on frailty and the need for long-term care among older adults in the Kozu District |
| Date of disclosure of the study information | 2025/08/25 |
| Last modified on | 2025/08/24 15:35:48 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study on frailty and the need for long-term care among older adults in the community-dwelling older adults
Acronym
Study on frailty and the need for long-term care among older adults in the community-dwelling older adults
Scientific Title
Study on frailty and the need for long-term care among older adults in the Kozu District
Scientific Title:Acronym
Study on frailty and the need for long-term care among older adults in the Kozu District
Region
| Japan |
Condition
Condition
Community-dwelling older adults
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to identify the risk and protective factors for frailty among older adults in the Kozu district.
Basic objectives2
Others
Basic objectives -Others
Relevance investigation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frailty status (frail, pre-frail, and robust) determined based on the revised J-CHS criteria.
Key secondary outcomes
As factors considered to be associated with frailty, we assess physical function (muscle strength, gait, exercise tolerance, balance), body composition, cognitive function, and speech-language-hearing function (hearing, swallowing vocalization, and interoception). In addition, a self-administered questionnaire used to collect information on medical history, lifestyle habits, physical activity, fall history, social activities, mental function, activities of daily living, self-efficacy, and driving.
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
Intervention using physical, cognitive, and speech-language-hearing assessments.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Older people, aged 65 over and living in the Kozu District
Key exclusion criteria
Those who are difficult to follow up.
Those whose native language is not Japanese.
Those from whom consent could not be obtained.
Those certified as requiring long-term care levels 1-5 at the initial assessment.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yuusuke |
| Middle name | |
| Last name | Nishida |
Organization
International University of Health and Welfare
Division name
Department of Physical Therapy, School of Health Sciences at Narita
Zip code
286-8686
Address
4-3 Kozunomori, Narita-City, Chiba, Japan
TEL
0476-20-7701
yuusuken@ihwg.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Ishii |
Organization
International University of Health and Welfare
Division name
Department of Physical Therapy, School of Health Sciences at Narita
Zip code
286-8686
Address
4-3 Kozunomori, Narita-City, Chiba, Japan
TEL
0476-20-7701
Homepage URL
h-ishii@ihwg.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
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
Chiba Area Institutional Review Board, International University of Health and Welfare
Address
4-3 Kozunomori, Narita-City, Chiba, Japan
Tel
0476-20-7708
rinri_md@ihwg.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
| 2025 | Year | 08 | Month | 25 | 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
| 2025 | Year | 08 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2031 | 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
| 2025 | Year | 08 | Month | 24 | Day |
Last modified on
| 2025 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067326
