UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053701 |
|---|---|
| Receipt number | R000061282 |
| Scientific Title | Verification of the effectiveness of dual-task training with singing to prevent dementia |
| Date of disclosure of the study information | 2024/02/25 |
| Last modified on | 2025/02/25 10:34:06 |
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Basic information
Public title
Verification of the effectiveness of dual-task training with singing to prevent dementia
Acronym
Effects of dual tasks involving singing
Scientific Title
Verification of the effectiveness of dual-task training with singing to prevent dementia
Scientific Title:Acronym
Effects of dual tasks involving singing
Region
| Japan |
Condition
Condition
Elderly people without dementia
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examining the effectiveness of dual tasks involving singing for primary prevention of dementia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese version of Montreal Cognitive Assessment (MoCA-J)
Evaluations will be conducted before and after 12 weeks of intervention to confirm effectiveness. Furthermore, after 12 weeks, a follow-up evaluation will be conducted to see if the effect persists.
Key secondary outcomes
Trail Making Test Japanese version (TMT-J)
Evaluations will be conducted before and after 12 weeks of intervention to confirm effectiveness. Furthermore, after 12 weeks, a follow-up evaluation will be conducted to see if the effect persists.
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
Intervention group: Dual-task training of singing and finger movement for 30 minutes once a week for 12 weeks.
Control group: While the intervention group undergoes training, they go about their daily lives as usual (No special intervention).
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 years who have not been diagnosed with dementia.
Key exclusion criteria
- Persons who have been certified as requiring support or nursing care. However, cases of physical support without cognitive problems are not excluded.
- Persons with a pre-intervention cognitive function test MoCA-J score of 20 or lower will be excluded.
- Persons with unstable mental condition or those who are hospitalized for mental illness are not eligible.
- Persons with less than 4 sets of hand and finger movement ability test results before the intervention will be excluded.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Kurakata |
Organization
Waseda University
Division name
Faculty of Human Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama
TEL
04-2947-6754
kurakata.kenji@waseda.jp
Public contact
Name of contact person
| 1st name | Nobue |
| Middle name | |
| Last name | Sasa |
Organization
Waseda University
Division name
Faculty of Human Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama
TEL
04-2947-6754
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 Committee on Human Research of Waseda University
Address
1-104 Totsukacho, Shinjuku, Tokyo
Tel
03-5272-1639
rinri@list.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
| 2024 | Year | 02 | Month | 25 | 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
Completed
Date of protocol fixation
| 2023 | Year | 12 | Month | 04 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | 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 | 02 | Month | 25 | Day |
Last modified on
| 2025 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061282
