UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056269 |
|---|---|
| Receipt number | R000064283 |
| Scientific Title | Effect of oral function training program on cognitive function in elderly people |
| Date of disclosure of the study information | 2024/11/26 |
| Last modified on | 2024/11/26 20:22:01 |
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Basic information
Public title
Effect of oral function training program on cognitive function in elderly people
Acronym
Effect of oral function training program on cognitive function in elderly people
Scientific Title
Effect of oral function training program on cognitive function in elderly people
Scientific Title:Acronym
Effect of oral function training program on cognitive function in elderly people
Region
| Japan |
Condition
Condition
Oral hypofunction
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effectiveness of a training program targeting oral and cognitive function through an intervention experiment targeting healthy elderly people aged 60 to 80 years, evaluating both oral and cognitive function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oral function: pronunciation function (oral diadochokinesis)
Cognitive function: executive function (Stroop test and reverse Stroop test), short-term memory and working memory (digit span)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Cognitive and oral function training
Interventions/Control_2
Oral function training
Interventions/Control_3
Active control
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
| 60 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Men and women aged 60-80 years (at the time of enrollment).
(2) Right-handed individuals.
(3) Individuals who understand the purpose and content of this study and have provided written consent to participate in the study.
Key exclusion criteria
(1) Individuals with a disorder of stomatognathic function or currently undergoing treatment for such disorder.
(2) Individuals who need to visit a dental clinic for dental treatment during the intervention period.
(3) Individuals who are judged to be hindered in the training due to ill-fitting dentures.
(4) Individuals who wear dentures with three or more consecutive missing teeth.
(5) Individuals classified as B2-C3 in the Eihiner classification.
(6) Individuals who play video games for one hour or more per week.
(7) Adults who do not have sufficient judgment ability.
(8) Individuals with a history of psychiatric disorders, diabetes, neurological disorders, or heart disease (cardiac disease).
(9) Individuals taking medications that affect cognitive function (e.g. benzodiazepines, antidepressants, central nervous system drugs).
(10) Individuals who score 26 or less on the MMSE-J (Mini Mental State Examination-Japanese), a screening test for dementia.
(11) Individuals who are currently participating in other studies or who have participated in other studies within two months prior to the start of the study.
(12) Anyone who participated in the research "Development of an oral function training program for cognitive function in the elderly" conducted in this field in 2022.
(13) Anyone who is unable to participate in the pre- and post-tests conducted before and after the intervention period.
(14) Anyone who is otherwise deemed inappropriate.
Target sample size
63
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Yoda |
Organization
Tohoku University Graduate School of Dentistry
Division name
Advanced Prosthetic Dentistry
Zip code
980-8575
Address
4-1, Seiryo-machi, Aoba-ku, Sendai, MIyagi
TEL
022-717-8369
nobuhiro.yoda.e2@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Masumi |
| Middle name | |
| Last name | Abe |
Organization
Tohoku University Graduate School of Dentistry
Division name
Advanced Prosthetic Dentistry
Zip code
9808575
Address
4-1, Seiryo-machi, Aoba-ku, Sendai, MIyagi
TEL
0227178369
Homepage URL
masumi.abe.b1@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Dentistry
Address
4-1, Seiryo-machi, Aoba-ku, Sendai, MIyagi
Tel
022-717-8244
den-syom@grp.tohoku.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 | 11 | Month | 26 | 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
| 2024 | Year | 11 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 05 | 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
| 2024 | Year | 11 | Month | 25 | Day |
Last modified on
| 2024 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064283
