UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050240 |
|---|---|
| Receipt number | R000052021 |
| Scientific Title | Evaluation of dementia-preventing effect of multitasking exercise by beta amyloid : 18-month randomized trial |
| Date of disclosure of the study information | 2023/05/01 |
| Last modified on | 2023/02/05 13:28:30 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of dementia-preventing effect of multitasking exercise by beta amyloid : 18-month randomized trial
Acronym
Evaluation of dementia prevention effect of multitasking exercise by beta amyloid
Scientific Title
Evaluation of dementia-preventing effect of multitasking exercise by beta amyloid : 18-month randomized trial
Scientific Title:Acronym
Evaluation of dementia prevention effect of multitasking exercise by beta amyloid
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to elucidate the dementia-preventing effect of SSE biochemically, Beta amyloid will be measured as the primary endpoints by Muldi-TOFMS. And cognitive function will be measured as a secondary endpoint in RCT (3 groups, intervention period 18 months).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Composite biomarker (Beta amyloid 1-40, beta amyloid 1-42, beta amyloid protein precursor 669-711)
Key secondary outcomes
cognitive function
Physical function
Physical activity
Mental health
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Square-stepping exercise
Interventions/Control_2
Walking
Interventions/Control_3
Control
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) A person who participated in the blood sampling test conducted by Kasama City in 2019
2) A person who is not prohibited from exercising by their doctor
3) A person who can go to the place where the experiment is conducted on their own
Key exclusion criteria
1) A person with dementia
2) A person with paralysis
3) A person who has an allergic reaction to the ingredients of the test food
4) A person who is currently participating in other clinical studies or who have participated within 3 months
5) A person who is judged by the principal investigator to be inappropriate as the subjects of this study
Target sample size
224
Research contact person
Name of lead principal investigator
| 1st name | Okura |
| Middle name | |
| Last name | Tomohiro |
Organization
University of Tsukuba
Division name
Faculty of Health and sport science
Zip code
305-8574
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
+81-29-853-2733
okura.tomohiro.gp@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | YOON |
| Middle name | |
| Last name | Jieun |
Organization
University of Tsukuba
Division name
R&D Center for Tailor-Made QOL
Zip code
305-8550
Address
1-2, kasuga, Tsukuba, Ibaraki, Japan
TEL
+81-029-839-1593
Homepage URL
yoon.jieunfu@u.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba, Faculty of Health and sport science, Research Ethics Committee
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
Tel
+81-029-853-2571
tg-kenkyurinri@un.tsukuba.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 | 05 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 05 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 05 | Day |
Last modified on
| 2023 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052021
