UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061186 |
|---|---|
| Receipt number | R000069463 |
| Scientific Title | Development of a Self-Management Program for Oral Frailty in community-dwelling elderly People |
| Date of disclosure of the study information | 2026/04/07 |
| Last modified on | 2026/04/07 15:19:24 |
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Basic information
Public title
Intervention Study of Improvement Program for Oral Frailty
Acronym
Prospective intervention study
Scientific Title
Development of a Self-Management Program for Oral Frailty in community-dwelling elderly People
Scientific Title:Acronym
Development of a Self-Management Program for Oral Frailty in community-dwelling elderly People
Region
| Japan |
Condition
Condition
Oral frailty
Classification by specialty
| Dental medicine | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of a self-training program for oral frailty
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of oral frailty
Key secondary outcomes
Improvement of individual items in the oral frailty score
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Daily for 3 months
Oral exercises
Tongue exercises
Pronunciation
Chewing exercises
Jaw exercises
Nutrition knowledge
Interventions/Control_2
Control
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
| 110 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Community-dwelling elderly individuals aged 65 and over who can understand the study content and provide written consent.
Evaluation of the research is possible.
Improvement program can be safely implemented.
Key exclusion criteria
Persons with cognitive impairments who have difficulty understanding research, giving consent, completing questionnaires, or undergoing assessments.
Persons who are restricted in the contents of intervention, such as oral treatment.
It is judged to be difficult to safely conduct the evaluation or intervention of the study.
A person deemed unsuitable as a research subject by the researcher.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Yukiko |
| Middle name | |
| Last name | Yamane |
Organization
Asahikawa Medical University
Division name
Department of Nursing
Zip code
078-8510
Address
2-1-1-1 Midorigaoka Higashi, Asahikawa City, Hokkaido, 078-8510, JAPAN
TEL
0166-65-2111
yamane@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Yukiko |
| Middle name | |
| Last name | Yamane |
Organization
Asahikawa Medical University
Division name
Department of Nursing
Zip code
078-8510
Address
2-1-1-1 Midorigaoka Higashi, Asahikawa City, Hokkaido, 078-8510, JAPAN
TEL
0166-65-2111
Homepage URL
yamane@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology : MEXT
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Asahikawa Medical University Research Ethics Committee
Address
2-1-1-1 Midorigaoka Higashi, Asahikawa City, Hokkaido, JAPAN
Tel
0166-68-2297
rs-kp.g@asahikawa-med.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 | 04 | Month | 07 | 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 | 02 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2027 | 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 | 07 | Day |
Last modified on
| 2026 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069463
