UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049782 |
|---|---|
| Receipt number | R000056573 |
| Scientific Title | Effect of exercise on cognitive function and biomarkers in community-dwelling elderly with mild cognitive impairment |
| Date of disclosure of the study information | 2022/12/16 |
| Last modified on | 2022/12/02 15:50:24 |
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Basic information
Public title
Effects of exercise on cognitive function and physiology in community-dwelling elderly
Acronym
Effect of Exercise on Cognitive Function and Physiology
Scientific Title
Effect of exercise on cognitive function and biomarkers in community-dwelling elderly with mild cognitive impairment
Scientific Title:Acronym
Effect of Exercise on Cognitive Function and Physiology
Region
| Japan |
Condition
Condition
Non
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The clarify the mechanism by which exercise improves cognitive function and the influence of genetic factors.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Before and 3 months after starting exercise
Cognitive function
Blood biomarkers
Genotype
Key secondary outcomes
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
exercise
Interventions/Control_2
non-exercise
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
| 60 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Community residents who participate in annual health checks conducted by researchers.
Key exclusion criteria
Those who have been stopped from exercising by a doctor
Persons with dementia
Those who are certified as needing long-term care
Those who have orthopedic disease, depression, or cerebrovascular disorder
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | Misa |
| Middle name | |
| Last name | Nakamura |
Organization
Osaka Kawasaki Rehabilitation University
Division name
Graduate School of Rehabilitation
Zip code
597-0104
Address
Mizuma 158, Kaizuka city, Osaka
TEL
072-446-6700
nakamuram@kawasakigakuen.ac.jp
Public contact
Name of contact person
| 1st name | Futoshi |
| Middle name | |
| Last name | Kawase |
Organization
Osaka Kawasaki Rehabilitation University
Division name
Research support section
Zip code
597-0104
Address
Mizuma 158, Kaizuka city, Osaka
TEL
072-446-6700
Homepage URL
soumu@kawasakigakuen.ac.jp
Sponsor or person
Institute
Osaka Kawasaki Rehabilitation University
Institute
Department
Personal name
Funding Source
Organization
Osaka Kawasaki Rehabilitation 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
Osaka Kawasaki Rehabilitation University
Address
Mizuma 158, Kaizuka city, Osaka
Tel
072-446-6700
nakamuram@kawasakigakuen.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 | 12 | Month | 16 | 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 | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 12 | Month | 16 | Day |
Last follow-up date
| 2023 | 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
| 2022 | Year | 12 | Month | 14 | Day |
Last modified on
| 2022 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056573
| Research Plan | |
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| 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 |
