UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053248 |
|---|---|
| Receipt number | R000059939 |
| Scientific Title | Studies on the effects of group tasks aimed at maintaining and improving oral function in elderly people living in the community |
| Date of disclosure of the study information | 2023/12/28 |
| Last modified on | 2023/12/28 11:28:35 |
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Basic information
Public title
Studies on the effects of playing games in groups to improve oral function
Acronym
Effects of a game aimed at improving oral function in groups
Scientific Title
Studies on the effects of group tasks aimed at maintaining and improving oral function in elderly people living in the community
Scientific Title:Acronym
Effects of group tasks aimed at maintaining and improving oral function in community-dwelling elderly people
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Rehabilitation medicine | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Healthy elderly people residing in the community will work in groups on issues aimed at maintaining and improving oral function, and will clarify the effects on oral frailty, prevention of dementia, and participation in social activities.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Vocalization duration, oral diadochokinesis, repeated saliva swallow test(RSST), tongue pressure, oral moisture, Mini Mental State Examination(MMSE), short version LSNS 6, WHOQOL OLD
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
100 healthy elderly people will be randomly divided into two groups: Group A (50 people) and Group B (50 people). During period 1 (3 months), Group A will carry out ``group tasks'' in which all participants complete tasks, and Group B will carry out ``individual tasks'' in which participants complete tasks individually. After that, a few days later, in Period 2 (3 months), Group A will carry out ``individual tasks'' and Group B will carry out ``group tasks.'' Evaluations will be made at the beginning and end of group or individual assignments.
Group A: Group tasks performed by all participants
Interventions/Control_2
Group B: Individual tasks where tasks are performed individually.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy elderly people living in the community who have given written consent
Key exclusion criteria
1) Persons wearing complete dentures
2) Persons with some kind of disease in the oral cavity
3) Persons diagnosed with dysphagia
4) Persons with anatomical (static) disorders related to eating and swallowing disorders
5) Persons who experience discomfort such as nausea or pain due to tooth, tongue, or olfactory stimulation 6) Persons with dementia or those who have difficulty communicating due to communication disorders
7) Persons who are objectively judged to lack the ability to give informed consent
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Takashima |
Organization
Kumamoto Health Science University
Division name
Faculty of Health Science Department of Nursing
Zip code
861-5598
Address
325 Izumimachi,Kita-ku,Kumamoto
TEL
096-275-2231
takashima@kumamoto-hsu.ac.jp
Public contact
Name of contact person
| 1st name | Misaki |
| Middle name | |
| Last name | Komura |
Organization
Kumamoto Health Science University
Division name
Academic and Research Promotion Division
Zip code
861-5598
Address
325 Izumimachi,Kita-ku,Kumamoto
TEL
096-275-2112
Homepage URL
kikaku@kumamoto-hsu.ac.jp
Sponsor or person
Institute
Kumamoto Health Science University
Institute
Department
Personal name
Funding Source
Organization
Kumamoto Health Science University
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
Kumamoto Health Science University Life Science Ethical Review Board
Address
325 Izumimachi,Kita-ku,Kumamoto
Tel
096-275-2112
kikaku@kumamoto-hsu.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
| 2023 | Year | 12 | Month | 28 | 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
100
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
Completed
Date of protocol fixation
| 2023 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 28 | Day |
Last follow-up date
| 2026 | 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
| 2023 | Year | 12 | Month | 28 | Day |
Last modified on
| 2023 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059939
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
