UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057801 |
|---|---|
| Receipt number | R000066061 |
| Scientific Title | Development and validation of an exercise program to improve symptoms in individuals with dementia, mild cognitive impairment, and those at high risk for psychiatric disorders |
| Date of disclosure of the study information | 2025/06/02 |
| Last modified on | 2025/05/08 17:30:31 |
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Basic information
Public title
Development and validation of an exercise program to improve symptoms in individuals with dementia, mild cognitive impairment, and those at high risk for psychiatric disorders: Kotobuki brain training study
Acronym
Kotobuki brain training study
Scientific Title
Development and validation of an exercise program to improve symptoms in individuals with dementia, mild cognitive impairment, and those at high risk for psychiatric disorders
Scientific Title:Acronym
Kotobuki brain training study
Region
| Japan |
Condition
Condition
Dementia, Mild cognitive impairment, Subjective cognitive decline
Classification by specialty
| Psychiatry | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the effects of exercise on cognitive and mental function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function (neuropsychological testing, brain imaging, blood tests, etc.) (assessed every 3 months)
Key secondary outcomes
Physical findings, physical function, activities of daily living
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Long-term intervention (up to 10 years) with a variety of exercise programs, twice a week for 60 or 90 minutes per session
Interventions/Control_2
Participants who do not wish to take part in the intervention but consent to the assessments will be included in the measurement-only group.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Residents of Kanoya City, Kagoshima Prefecture, who meet one of the following criteria:
1) Individuals with dementia
2) Individuals with mild cognitive impairment
3) Individuals with subjective cognitive decline
Key exclusion criteria
1) Individuals for whom performing the exercise would be hazardous.
2) Individuals with severe dementia who have difficulty understanding the exercise or measurements
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Nakagaichi |
Organization
National Institute of Fitness and Sports in KANOYA
Division name
Sports Innovation Organization; Department of Sports and Life Science
Zip code
8912393
Address
Shiromizu 1, Kanoya city, Kagoshima prefecture
TEL
0994-46-4111
gaichi@nifs-k.ac.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Uchida |
Organization
National Institute of Fitness and Sports in KANOYA
Division name
Health and Sports Promotion Department, Sports Innovation Organization
Zip code
8912393
Address
Shiromizu 1, Kanoya city, Kagoshima prefecture
TEL
0994-46-4111
Homepage URL
r-uchida@nifs-k.ac.jp
Sponsor or person
Institute
National Institute of Fitness and Sports in KANOYA
Institute
Department
Personal name
Funding Source
Organization
National Institute of Fitness and Sports in KANOYA
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Wakeikai Heiwadai Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the institutional ethics committee of the National Institute of Fitness and Sports in Kanoya
Address
Shiromizu 1, Kanoya city, Kagoshima prefecture
Tel
0994-46-4111
kokusai@nifs-k.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
医療法人和敬会平和台病院（鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2035 | 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 | 05 | Month | 08 | Day |
Last modified on
| 2025 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066061
