UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056824 |
|---|---|
| Receipt number | R000064515 |
| Scientific Title | Effects of regular exercise on the cognitive function in older adults: An exploratory study focusing on the movement creativity and improvisation |
| Date of disclosure of the study information | 2025/01/28 |
| Last modified on | 2026/01/29 10:04:45 |
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Basic information
Public title
Effects of exercise through creative movement and improvisation on the cognitive function in older adults
Acronym
Effects of creative and improvisational exercises on cognitive function in older adults
Scientific Title
Effects of regular exercise on the cognitive function in older adults: An exploratory study focusing on the movement creativity and improvisation
Scientific Title:Acronym
Effects of exercise on the cognitive function in older adults: An exploratory study focusing on the movement creativity and improvisation
Region
| Japan |
Condition
Condition
Older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of creative/improvised exercise and directed exercise on cognitive function in older adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Trail Making Test (cognitive function)
Key secondary outcomes
Positive and Negative Affect Schodule scales (Psychological function)
self-efficacy (Psychological function)
Rating of perceived exertion (Exercise Intensity)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
YES
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
Creative and improvisational dance
Interventions/Control_2
Aerobic dance
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Age 65 years or older.
The person who is not prohibited from exercising by a doctor.
The person who can come to the venue by themselves.
Key exclusion criteria
The person who has a medical history of cerebrovascular disease, cardiac disease, neurodegenerative disease, dementia.
The person who has a present illness of cerebrovascular disease, cardiac disease, neurodegenerative disease, dementia.
The person who is currently certified as being in need of long-term care
The total score of MMSE 23<=
The total score of GDS 7>=
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Ayane |
| Middle name | |
| Last name | Sato |
Organization
Kochi University
Division name
Faculty of Regional Collaboration
Zip code
780-8520
Address
2-5-1, Akebono-Cho, Kochi-city, Kochi, JAPAN
TEL
088-844-8097
sato.ayane@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Ayane |
| Middle name | |
| Last name | Sato |
Organization
Kochi University
Division name
Faculty of Regional Collaboration
Zip code
780-8520
Address
2-5-1, Akebono-Cho, Kochi-city, Kochi, JAPAN
TEL
088-844-8097
Homepage URL
sato.ayane@kochi-u.ac.jp
Sponsor or person
Institute
Kochi University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Research Ethics Committee of Collaborative Community Studies Unit, Kochi University
Address
2-5-1, Akebono-Cho, Kochi-city, Kochi, JAPAN
Tel
088-888-8045
ks52@kochi-u.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
| 2025 | Year | 01 | Month | 28 | 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
32
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
| 2024 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 22 | Day |
Last follow-up date
| 2026 | 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 | 01 | Month | 27 | Day |
Last modified on
| 2026 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064515
