UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059267 |
|---|---|
| Receipt number | R000067721 |
| Scientific Title | Development of a home program based on dual-task training of singing and finger movements for elderly people and its effect on cognitive function |
| Date of disclosure of the study information | 2025/10/02 |
| Last modified on | 2025/10/02 12:17:50 |
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Basic information
Public title
Development of a home program based on dual-task training of singing and finger movements for elderly people and its effect on cognitive function
Acronym
Development and impact of a dual-task home program of singing and finger movements
Scientific Title
Development of a home program based on dual-task training of singing and finger movements for elderly people and its effect on cognitive function
Scientific Title:Acronym
Development and impact of a dual-task home program of singing and finger movements
Region
| Japan |
Condition
Condition
Elderly people who have not been diagnosed with dementia
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of a dual-task home program of singing and finger movements and its impact on cognitive function
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese version of Montreal Cognitive Assessment
Trail Making Test (Part A and Part B)
Digit Span Task (forward and reverse order recitation)
Key secondary outcomes
Physical Activity Enjoyment Scale
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
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Perform a dual-task home program of singing and finger movements every day for about 15 minutes for 4 weeks.
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
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
People aged 65 to 95 who have not been diagnosed with dementia.
Key exclusion criteria
Exclude people with a score of 20 or less on the first cognitive function test (MoCA-J).
Exclude people with an unstable mental state or people currently receiving treatment for a mental illness.
Exclude people who have difficulty writing.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Risa |
| Middle name | |
| Last name | Suzuki |
Organization
Waseda University
Division name
Faculty of Human Sciences
Zip code
3591192
Address
2-579-1 Mikashima, Tokorozawa, Saitama
TEL
042-947-6895
risas@waseda.jp
Public contact
Name of contact person
| 1st name | Nobue |
| Middle name | |
| Last name | Sasa |
Organization
Waseda University
Division name
Graduate School of Human Sciences
Zip code
3591141
Address
2-579-1 Mikashima, Tokorozawa, Saitama
TEL
042-947-6946
Homepage URL
sasa2021@ruri.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Waseda 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
Ethics Review Procedures concerning Research with Human Subjects
Address
1-104 Totsuka-cho, Shinjuku-ku, Tokyo
Tel
03-5272-1639
rinri@lost.waseda.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
| 2025 | Year | 10 | Month | 02 | 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
| 2025 | Year | 09 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 10 | Month | 02 | Day |
Last modified on
| 2025 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067721
