UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050906 |
|---|---|
| Receipt number | R000056527 |
| Scientific Title | Effect of one creative dance practice on the cognitive function of older people |
| Date of disclosure of the study information | 2023/04/23 |
| Last modified on | 2024/04/22 12:57:39 |
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Basic information
Public title
Effect of movement-creating dance activity on the cognitive function of older people
Acronym
Effect of creative dance on the cognitive function of older people
Scientific Title
Effect of one creative dance practice on the cognitive function of older people
Scientific Title:Acronym
Effect of creative dance practice on the cognitive function of older people
Region
| Japan |
Condition
Condition
Older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of one creative dance practice on the cognitive function of the older adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stroop test (cognitive function)
Key secondary outcomes
Two-Dimensional Mood Scale (Mood)
Physical Activity Enjoyment Scale (Psychological function)
Heart rate (Exercise Intensity)
Rating of perceived exertion (Exercise Intensity)
Stories about the dance experience (Subjective dance experience)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
creative dance
Interventions/Control_2
aerobic dance
Interventions/Control_3
rest
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.
The person who can continue to practice exercise for 25 minutes.
Key exclusion criteria
The person who has a medical history of cerebrovascular disease, cardiac disease, neurodegenerative disease, glaucoma, cataract, color blindness.
The person who has a present illness of cerebrovascular disease, cardiac disease, neurodegenerative disease, glaucoma, cataract, color blindness.
The person who has symptoms of color blindness.
The total score of MMSE 23<=
The total score of GDS 7>=
Target sample size
12
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
Ethical Review Board of Kochi Medical School
Address
Kohasu, Oko-cho, Nankoku-shi, Kochi, JAPAN
Tel
088-880-2180
is21@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
| 2023 | Year | 04 | Month | 23 | 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
12
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
| 2022 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 23 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 04 | Month | 22 | Day |
Last modified on
| 2024 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056527
| Research Plan | |
|---|---|
| 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 |
