UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060562 |
|---|---|
| Receipt number | R000069224 |
| Scientific Title | The Effect of "Kamikami Gokugoku Taiso" (a mastication and swallowing exercise) on Oral Function. |
| Date of disclosure of the study information | 2026/02/05 |
| Last modified on | 2026/02/06 11:56:40 |
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Basic information
Public title
The Effect of "Kamikami Gokugoku Taiso" (a mastication and swallowing exercise) on Oral Function.
Acronym
KAMI-GOKU Study
Scientific Title
The Effect of "Kamikami Gokugoku Taiso" (a mastication and swallowing exercise) on Oral Function.
Scientific Title:Acronym
MASE-OF Study: Mastication and Swallowing Exercise for Oral Function Study
Region
| Japan |
Condition
Condition
Oral frailty
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify the effects of performing "Kamikami Gokugoku Taiso" continuously for a certain period on improving oral function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in maximum tongue pressure from baseline to 8 weeks.
Key secondary outcomes
Change in masticatory function from baseline to 8 weeks.
Change in the number of repetitions in the Repetitive Saliva Swallowing Test (RSST) from baseline to 8 weeks.
Change in swallowing interval time from baseline to 8 weeks.
Change in oral diadochokinesis (ODK) from baseline to 8 weeks.
Change in maximum occlusal force from baseline to 8 weeks.
Change in lip closure strength from baseline to 8 weeks.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention: Implementation of the "Kamikami Gokugoku Taiso" exercise.
Frequency: Three times a day (e.g., before/after breakfast, lunch, and dinner).
Volume: Six sets per session (approx. 20 minutes per session).
Duration: Daily for approximately 2 months.
Adherence monitoring: Participants will self-record their exercise implementation on a daily checklist.
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
| 50 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Individuals who have received a full explanation of the purpose and details of this study and have voluntarily provided written informed consent to
participate.
2.Individuals who answered "yes" to one or both of the following questions on the Oral Frailty 5-item Checklist (OF-5):
"Do you have more difficulty eating hard foods now than you did six months ago?"
"Do you ever choke on tea or soup?"
3.Individuals who have not been certified as requiring long-term care or support (i.e., not receiving "Yo-kaigo" or "Yo-shien" certification).
Key exclusion criteria
Dental-related criteria
Individuals with complete dentures in both the maxilla and mandible.
2. Individuals currently undergoing orthodontic treatment.
3. Individuals receiving dental treatment that may affect oral function (excluding routine check-ups and cleanings).
4. Individuals who experience pain upon occlusion, making it difficult to perform the evaluations specified in this study.
Systemic conditions and medical history
5. Individuals with poorly controlled systemic diseases (e.g., diabetes, liver disease, kidney disease, heart disease) that may affect the implementation of this study, or those who cannot obtain permission from their primary physician to participate.
6. Individuals with severe respiratory disease for whom swallowing training with a load is contraindicated as judged by a physician.
Temporary conditions and medication history
7. Individuals with fever (e.g., 37.5C or higher) or symptoms suggestive of an acute infection at the time of each evaluation.
8. Individuals who have taken systemic antibiotics within one month prior to the baseline evaluation.
Other
9. Individuals otherwise judged to be unsuitable for this study by the principal investigator.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Kurita |
Organization
The Lion Foundation for Dental Health
Division name
Department of Research
Zip code
111-8644
Address
1-3-28 Kuramae, Taito-ku, Tokyo , Japan
TEL
+81-3-6739-9000
kei-k@lion.co.jp
Public contact
Name of contact person
| 1st name | Tomoka |
| Middle name | |
| Last name | Kasen |
Organization
The Lion Foundation for Dental Health
Division name
Department of Research
Zip code
111-8644
Address
1-3-28 Kuramae, Taito-ku, Tokyo , Japan
TEL
0367399000
Homepage URL
tomoka-s@lion.co.jp
Sponsor or person
Institute
The Lion Foundation for Dental Health
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS) 25K13028
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board (IRB) of The Lion Foundation for Dental Health
Address
1-3-28 Kuramae, Taito-ku, Tokyo , Japan
Tel
0367399000
ayae-mg@lion.co.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
ライオン本社内会議室
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 05 | 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 | 01 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 06 | 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
| 2026 | Year | 02 | Month | 03 | Day |
Last modified on
| 2026 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069224
