UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054059 |
|---|---|
| Receipt number | R000061721 |
| Scientific Title | Effects of aging on oral, swallowing, and physical function |
| Date of disclosure of the study information | 2024/04/04 |
| Last modified on | 2024/04/19 10:14:25 |
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Basic information
Public title
Effects of aging on oral, swallowing, and physical function
Acronym
Effects of aging on oral, swallowing, and physical function
Scientific Title
Effects of aging on oral, swallowing, and physical function
Scientific Title:Acronym
Effects of aging on oral, swallowing, and physical function
Region
| Japan |
Condition
Condition
Normal people, elderly people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this project is to obtain a wide range of data on physical function, oral function, and swallowing function from young adults to the elderly, and to examine the effects of aging on these functions by examining factors related to frailty in more depth, thereby contributing to the extension of healthy life expectancy in the future.
Basic objectives2
Others
Basic objectives -Others
The purpose of this project is to obtain a wide range of data on physical function, oral function, and swallowing function from young adults to the elderly, and to examine the effects of aging on these functions by examining factors related to frailty in more depth, thereby contributing to the extension of healthy life expectancy in the future.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Relationship between masticatory function and loss of function due to swallowing sounds.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Perform gait measurements, swallowing measurements, and oral function tests for this study.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Persons who are able to obtain free and voluntary written consent for participation in research from the individual concerned.
2.Persons who are 18 years of age or older at the time of obtaining consent.
Key exclusion criteria
1.Persons with severe hearing impairment
2.Those who have difficulty in walking indoors on level ground by themselves.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kumiko |
| Middle name | |
| Last name | Yoshihara |
Organization
National Institute of Advanced Industrial Science and Technology
Division name
Health and Medical Research Institute
Zip code
7610395
Address
2217-14, Hayashi-cho, Takamatsu, Kagawa
TEL
050-3522-7455
kumiko.yoshihara@aist.go.jp
Public contact
Name of contact person
| 1st name | Kumiko |
| Middle name | |
| Last name | Yoshihara |
Organization
National Institute of Advanced Industrial Science and Technology
Division name
Health and Medical Research Institute
Zip code
761-0395
Address
2217-14, Hayashi-cho, Takamatsu, Kagawa
TEL
050-3522-7455
Homepage URL
erlbach87@gmail.com
Sponsor or person
Institute
National Institute of Advanced Industrial Science and Technology
Institute
Department
Personal name
Funding Source
Organization
No
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institute of Advanced Industrial Science and Technology
Address
Tsukuba higashi1-1-1
Tel
029-861-2120
safe-life-ml@aist.go.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
国立研究開発法人産業技術総合研究所
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2029 | 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
| 2024 | Year | 04 | Month | 04 | Day |
Last modified on
| 2024 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061721
