UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048520 |
|---|---|
| Receipt number | R000055286 |
| Scientific Title | Effect of group-based cognitive training on cognitive and brain functions in healthy older adults |
| Date of disclosure of the study information | 2022/07/30 |
| Last modified on | 2022/07/30 05:30:32 |
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Basic information
Public title
Effect of group-based cognitive training on cognitive and brain functions in healthy older adults
Acronym
Effect of group-based cognitive training on cognitive and brain functions in healthy older adults
Scientific Title
Effect of group-based cognitive training on cognitive and brain functions in healthy older adults
Scientific Title:Acronym
Effect of group-based cognitive training on cognitive and brain functions in healthy older adults
Region
| Japan |
Condition
Condition
healthy older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate whether group-based cognitive training improve cognitive and brain functions in healthy older adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
digit symbol cording, symbol search
Key secondary outcomes
Stroop test, verba fluency, Raven matrix, JART, logical memory, digit span, D=CAT, mental rotation, brain activity, STAI, WHO-5, GHQ12, POMS, CES-D
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Participants receive group-based cognitve training using calculation and reading aloud for 20weeks (30 minutes group-based training
per week).
Interventions/Control_2
Participants receive cognitve training using calculation and reading aloud(30 minutes training
per week).
Interventions/Control_3
no intervention (passive control group)
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
| 60 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Native Japanese right handed older adults
Key exclusion criteria
We will exclude the subjects with mental disorder, diabetes, cranial nerve disease, cardiac disease, lower MMSE score (less than 26), taking medicines related to cognitive function.
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Ryuta |
| Middle name | |
| Last name | Kawashima |
Organization
Tohoku University
Division name
IDAC
Zip code
9808575
Address
Sendai, Seiryo-machi4-1
TEL
022-717-7988
fbi@idac.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Rui |
| Middle name | |
| Last name | Nouchi |
Organization
Tohoku Univeristy
Division name
IDAC
Zip code
9808575
Address
Sendai, Seiryo-machi4-1
TEL
022-717-8592
Homepage URL
rui@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Kumon Institute of Education Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
Sendai, Seiryo2-1
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2022 | Year | 07 | Month | 30 | 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
| 2022 | Year | 07 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 08 | 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
| 2022 | Year | 07 | Month | 30 | Day |
Last modified on
| 2022 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055286
| 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 |
