UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061020 |
|---|---|
| Receipt number | R000069828 |
| Scientific Title | Effect of exercise and cognitive training interventions on markers of mild cognitive impairment risk |
| Date of disclosure of the study information | 2026/03/24 |
| Last modified on | 2026/03/23 15:29:48 |
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Basic information
Public title
Effect of exercise and cognitive training interventions on markers of mild cognitive impairment risk
Acronym
Effect of exercise and cognitive training interventions on markers of mild cognitive impairment risk
Scientific Title
Effect of exercise and cognitive training interventions on markers of mild cognitive impairment risk
Scientific Title:Acronym
Effect of exercise and cognitive training interventions on markers of mild cognitive impairment risk
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
e divided individuals at high risk for mild cognitive impairment into a group that received exercise and cognitive training and a group that did not, then tracked MCI risk indicators and observed and compared changes in their values.
Basic objectives2
Others
Basic objectives -Others
We will evaluate the efficacy of the intervention and assess whether MCI risk indicators derived from urine or serum correlate with established cognitive measures.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in the MCI risk indicator derived from the urinary trace element profile
Key secondary outcomes
Serum trace element profile
Urinary trace element concentrations
MCI risk indicator derived from serum trace element profile
Mini-Cog
pegboard test score
Grip strength
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
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Participants will perform one 1-hour session each of cognitive training and exercise training per week for 5 months.
Interventions/Control_2
The control group will continue their usual lifestyle.
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
| 55 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Participants with a high MCI risk index calculated from their serum trace element profiles.
Key exclusion criteria
Participants diagnosed with dementia (mild cognitive impairment excluded)
Participants with medical conditions for which mild exercise is contraindicated.
Participants judged by the investigators to be unsuitable for participation in this study.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Shunsuke |
| Middle name | |
| Last name | Fujimoto |
Organization
Renatech Co., Ltd.
Division name
Health Care Analysis Center
Zip code
259-1114
Address
4-19-15 Takamori, Isehara, Kanagawa, Japan
TEL
0463-92-6114
fujimoto@renatech.net
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | |
| Last name | Fujimoto |
Organization
Renatech Co., Ltd.
Division name
Health Care Analysis Center
Zip code
259-1114
Address
4-19-15 Takamori, Isehara, Kanagawa, Japan
TEL
0463-92-6114
Homepage URL
fujimoto@renatech.net
Sponsor or person
Institute
Renatech Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
METI(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Gifu University of Medical Science
University of Tsukuba
Name of secondary funder(s)
Renatech Co., Ltd.
IRB Contact (For public release)
Organization
Renatech Ethics Review Committee
Address
4-19-15 Takamori Isehara-shi, Kanagawa 259-1114 Japan
Tel
0463-92-6114
shimizu@renatech.net
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
| 2026 | Year | 03 | Month | 24 | 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
| 2026 | Year | 03 | Month | 02 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 25 | 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
| 2026 | Year | 03 | Month | 23 | Day |
Last modified on
| 2026 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069828
