UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038094 |
|---|---|
| Receipt number | R000043412 |
| Scientific Title | Effect of masticatory ability on physical function and outcome of the long-term care prevention program in elderly people |
| Date of disclosure of the study information | 2019/09/25 |
| Last modified on | 2024/01/20 11:26:48 |
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Basic information
Public title
Effect of masticatory ability on physical function and outcome of the long-term care prevention program in elderly people
Acronym
Effect of masticatory ability on physical function and outcome of the long-term care prevention program in elderly people
Scientific Title
Effect of masticatory ability on physical function and outcome of the long-term care prevention program in elderly people
Scientific Title:Acronym
Effect of masticatory ability on physical function and outcome of the long-term care prevention program in elderly people
Region
| Japan |
Condition
Condition
healthy elderly
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study is to investigate the correlation between masticatory ability and physical function or fall risks in healthy elderly people. The effect of masticatory ability on the outcome of the long-term care prevention program will be also examined.
Basic objectives2
Others
Basic objectives -Others
We will try to develope a system for evaluating fall risks among elderly people based on the masticatory ability. The utility of the system in estimating the effect of the long-term care prevention program on the physical function will be also examined.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
frequency of falling
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Living in Osaka City
Key exclusion criteria
People who are difficult to walk by themselves (regardless of the use of walk aid)/Oral disorder (regardless of the use of prosthetic tooth)
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Hisayo |
| Middle name | |
| Last name | Yokoyama |
Organization
Osaka City University Graduate School of Medicine
Division name
Environmental Physiology for Exercise
Zip code
558-8585
Address
3-3-138, Sugimoto, Sumiyoshi-ku, Osaka City
TEL
0666052947
yokoyama@sports.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Hisayo |
| Middle name | |
| Last name | Yokoyama |
Organization
Osaka City University Graduate School of Medicine
Division name
Environmental Physiology for Exercise
Zip code
558-8585
Address
3-3-138, Sugimoto, Sumiyoshi-ku, Osaka City
TEL
0666052947
Homepage URL
yokoyama@sports.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Osaka City University Graduate School of Medicine
Address
1-2-7-601, Asahi-Machi, Abeno-ku, Osaka City
Tel
0666453456
ethics@med.osaka-cu.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
| 2019 | Year | 09 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.osakagas.co.jp/company/efforts/fukushi/jyosei/kenkyu_kako21.html
Number of participants that the trial has enrolled
136
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
Main results already published
Date of protocol fixation
| 2019 | Year | 08 | Month | 22 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Measurements
1. masutocatory ability: how fine the gummi candy was crashed after 30 chewings
2. other oral functions: oral diadochokinesis, number of the existing tooth
3. physical functions: grip power, quadriceps muscle strength, one-leg standing time, functional reach, Timed Up and Go
4. anthropometry: body height, body weight, body mass index, body fat mass, lean body mass
5. events of falling, objective risk factor for falling, activity of daily life using a questionnaire
6. Food Frequency Questionnaire
Management information
Registered date
| 2019 | Year | 09 | Month | 25 | Day |
Last modified on
| 2024 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043412
