UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050333 |
|---|---|
| Receipt number | R000056955 |
| Scientific Title | Intervention study on oral frailty program for community-dwelling elderly people |
| Date of disclosure of the study information | 2023/02/14 |
| Last modified on | 2025/12/29 17:05:24 |
* 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
Intervention study of preventive program for oral frailty
Acronym
Prospective intervention study
Scientific Title
Intervention study on oral frailty program for community-dwelling elderly people
Scientific Title:Acronym
Intervention study on oral frailty program for community-dwelling elderly people
Region
| Japan |
Condition
Condition
Oral frailty
Classification by specialty
| Dental medicine | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of the oral frailty prevention program
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
Cross-over
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 | Other |
Interventions/Control_1
Daily for 3 months
Oral gymnastics
Training of tongue movement
Pronunciation training
Mastication training
Jaw movement
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy people over 65 years old, people with support level 1 to long-term care level 2.
Those who can do the oral function improvement program by themself with the pamphlet.
Key exclusion criteria
Elderly people requiring long-term care 3-5
Target sample size
210
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
Japan
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-kk.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
| 2023 | Year | 02 | Month | 14 | Day |
Related information
URL releasing protocol
https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-22K11197/
Publication of results
Unpublished
Result
URL related to results and publications
https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-22K11197/
Number of participants that the trial has enrolled
162
Results
To examine the effects of the program, analyses were adjusted for sex, age, and baseline care level. The intervention group showed a higher odds ratio for oral frailty than the control group (OR = 4.351). In contrast, the intervention group showed significantly lower odds ratios for malnutrition risk assessed by the MNA-SF, tongue pressure, and Pa and Ka values below six, indicating a preventive effect. Further investigation and continued refinement of oral frailty prevention programs are needed.
Results date posted
| 2025 | Year | 12 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants were residents of City A aged 65 years or older. They comprised healthy individuals and those requiring support levels 1 to care level 2. They were able to walk at least 5 meters, sign the research consent form, and perform oral exercises independently at home using the provided pamphlet. Furthermore, they were able to undergo oral frailty questionnaires and measurements three months later.
Participant flow
Participants were recruited from areas near universities in City A frequented by elderly residents. Community, town councils, and residential facilities were contacted, and districts permitting circular distribution were also approached. After obtaining permission, researchers visited these locations, explained the study, and enrolled elderly residents who gave consent. Assessments were conducted at baseline and after three months. The intervention group implemented the program at home for three months, while the control group did not receive any intervention. To ensure fairness, the control group began the program after three months, with follow-up assessments conducted at six months.
Adverse events
There is no report.
Outcome measures
Oral frailty check, oral function, simplified nutritional indicator, simplified swallowing function, frailty
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 14 | Day |
Last modified on
| 2025 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056955
