UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061246 |
|---|---|
| Receipt number | R000070080 |
| Scientific Title | A Multidimensional Investigation of Oral Frailty and Preventive Interventions |
| Date of disclosure of the study information | 2026/05/01 |
| Last modified on | 2026/04/13 19:08:26 |
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Basic information
Public title
A Multidimensional Investigation of Oral Frailty and Preventive Interventions
Acronym
A Multidimensional Investigation of Oral Frailty and Preventive Interventions
Scientific Title
A Multidimensional Investigation of Oral Frailty and Preventive Interventions
Scientific Title:Acronym
A Multidimensional Investigation of Oral Frailty and Preventive Interventions
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Frailty, characterized by decreased muscle strength and physical activity, has been reported to significantly increase the risks of falls, disability, hospitalization, and mortality (Fried et al., 2001). It is also associated with depression and cognitive decline, leading to reduced quality of life (QOL). Although frailty is potentially reversible, delayed intervention may result in progression to sarcopenia and disability.
Oral frailty (OF) refers to a state of impaired oral function, including eating and swallowing, which can lead to malnutrition. As a precursor to physical frailty, OF may progress to systemic frailty if left untreated. Therefore, early intervention at the OF stage is essential; however, the physical characteristics associated with OF remain unclear.
This study aims to identify factors associated with OF from a multidimensional perspective, including physical function as well as pain and sleep disturbances. In addition, exercise-based interventions will be provided, and participants will be evaluated every six months to longitudinally examine their effects on the prevention and improvement of OF.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
OFI-8
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
After the baseline assessment, participants will receive interventions primarily consisting of educational lectures on oral frailty and frailty (using videos and slides) as well as exercise guidance (including demonstrations and printed materials).
Subsequently, the same assessments will be conducted every six months to longitudinally examine changes in oral frailty and related factors, as well as the effects of the intervention.
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
| 20 | years-old | <= |
Age-upper limit
| 99 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy community-dwelling residents who provided informed consent for participation in this study
Key exclusion criteria
Individuals with cognitive impairment
Individuals with a history of oral or head and neck surgery
Individuals using a pacemaker
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | yanogawa |
| Middle name | |
| Last name | taiki |
Organization
Kochi Medical School Hospital, Kochi University
Division name
Department of Rehabilitation,
Zip code
7830043
Address
185-1 Kohasu, Oko-cho, Nankoku, Kochi Japan
TEL
088-880-2490
jm-t.yanogawa@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | yanogawa |
| Middle name | |
| Last name | taiki |
Organization
Kochi Medical School Hospital, Kochi University
Division name
Department of Rehabilitation
Zip code
7830043
Address
185-1 Kohasu, Oko-cho, Nankoku, Kochi Japan
TEL
088-880-2490
Homepage URL
jm-t.yanogawa@kochi-u.ac.jp
Sponsor or person
Institute
Kochi Medical School Hospital, Kochi University
Institute
Department
Personal name
Funding Source
Organization
No
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
Kochi Medical School Hospital, Kochi University
Address
185-1 Kohasu, Oko-cho, Nankoku, Kochi Japan
Tel
088-880-2490
jm-t.yanogawa@kochi-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
| 2026 | Year | 05 | 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
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
| 2026 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | 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
| 2026 | Year | 04 | Month | 13 | Day |
Last modified on
| 2026 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070080
