UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061143 |
|---|---|
| Receipt number | R000069970 |
| Scientific Title | Examination of the Effect of UDe-sport for cognitive functions in community-dwelling older people |
| Date of disclosure of the study information | 2026/04/03 |
| Last modified on | 2026/04/03 09:04:35 |
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Basic information
Public title
Examination of the Effect of UDe-sport for cognitive functions in community-dwelling older people
Acronym
Examination of the Effect of UDe-sport for cognitive functions in community-dwelling older people
Scientific Title
Examination of the Effect of UDe-sport for cognitive functions in community-dwelling older people
Scientific Title:Acronym
Examination of the Effect of UDe-sport for cognitive functions in community-dwelling older people
Region
| Japan |
Condition
Condition
older people
Classification by specialty
| Rehabilitation medicine | Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examination of the effect of UDe-sport for cognitive function in older people
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Trail Making Test, Digit Symbol Substitution Test, MMSE
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
UDe-Sports is conducted once a week (15 minutes per session).
UDe-Sports include 4-5 games related to cognitive functions (such as attention and processing speed), including ball tossing and Daruma-otoshi (where points are accumulated by pressing buttons of the corresponding colors).
Interventions/Control_2
The control group conducted normal salon activities
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
Community-dwelling older adults who do not have neurological conditions that affect cognitive function
Key exclusion criteria
Neurological disorders that affect cognitive function
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takasuke |
| Middle name | |
| Last name | Miyazaki |
Organization
Kumamoto Health Science University
Division name
Faculty of Health Science
Zip code
861-5598
Address
325 Izumi-machi, kita-ku, kumamoto
TEL
096-275-2162
miyazaki-tk@kumamoto-hsu.ac.jp
Public contact
Name of contact person
| 1st name | Takasuke |
| Middle name | |
| Last name | Miyazaki |
Organization
Kumamoto Health Science University
Division name
Faculty of Health Science
Zip code
861-5598
Address
325 Izumi-machi, kita-ku, kumamoto
TEL
096-275-2162
Homepage URL
miyazaki-tk@kumamoto-hsu.ac.jp
Sponsor or person
Institute
Kumamoto Health Science University
Institute
Department
Personal name
Funding Source
Organization
Kumamoto Health Science 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
Kumamoto Health Science University
Address
325 Izumi-machi, kita-ku, kumamoto
Tel
096-275-2162
miyazaki-tk@kumamoto-hsu.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
| 2026 | Year | 04 | Month | 03 | 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
| 2025 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 06 | 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 | 04 | Month | 03 | Day |
Last modified on
| 2026 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069970
