UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055848 |
|---|---|
| Receipt number | R000063826 |
| Scientific Title | Impact on oral and physical function of oral exercise program and participation in a community gathering place |
| Date of disclosure of the study information | 2024/10/16 |
| Last modified on | 2025/10/20 12:37:00 |
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Basic information
Public title
Impact on oral and physical function of oral exercise program and participation in a community gathering place
Acronym
Impact on oral and physical function of oral exercise program and participation in a community gathering place
Scientific Title
Impact on oral and physical function of oral exercise program and participation in a community gathering place
Scientific Title:Acronym
Impact on oral and physical function of oral exercise program and participation in a community gathering place
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the impact of an oral exercise program and participation in a community gathering place on oral and physical function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
chewing ability
Key secondary outcomes
Dental formula
Oral cleanliness
Tongue pressure
Oral motor function
Bite strength
Oral cavity moisture level
Weight and height
Grip strength
Walking speed
Duration of standing on one leg with eyes open
Questionnaire
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
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
oral exercise program and participation in a community gathering place
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Those who are able to implement the oral exercise program.
(2)Those who have received sufficient explanation of the purpose and content of the study, have the ability to consent, have voluntarily volunteered to participate with a good understanding, and have agreed to participate in this study in writing
Key exclusion criteria
(1) Those who may develop allergies related to the study
(2) Those who are deemed by the investigator to be inappropriate to participate in this study
(3) Those whose implementation rate of oral exercises was less than 80%.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazuto |
| Middle name | |
| Last name | Okabayashi |
Organization
Lotte Co., Ltd.
Division name
Research and Development Center, Kamukoto Research Department
Zip code
336-8601
Address
1-1, Numakage-3chome, Minami-ku, Saitama
TEL
048-837-0744
okabayashi_kazuto@lotte.co.jp
Public contact
Name of contact person
| 1st name | Susumu |
| Middle name | |
| Last name | Kanno |
Organization
Lotte Co., Ltd.
Division name
Research and Development Center, Kamukoto Research Department
Zip code
336-8601
Address
1-1, Numakage-3chome, Minami-ku, Saitama
TEL
048-837-0744
Homepage URL
kanno_susumu@lotte.co.jp
Sponsor or person
Institute
Lotte Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Aichi prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Eisai Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Eisai Research Ethics Review Committee
Address
5-1-3 Tokodai, Tsukuba, Ibaraki 300-2635, Japan
Tel
070-2474-2971
m-kogushi@hhc.eisai.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 16 | 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
32
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 28 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 12 | Day |
Date of closure to data entry
| 2025 | Year | 02 | Month | 21 | Day |
Date trial data considered complete
| 2025 | Year | 02 | Month | 21 | Day |
Date analysis concluded
| 2025 | Year | 07 | Month | 18 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 16 | Day |
Last modified on
| 2025 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063826
