UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059864 |
|---|---|
| Receipt number | R000068443 |
| Scientific Title | A Parallel-Group Randomized Controlled Trial to Evaluate the Effects of eSports and Technology-Based Cognitive, Physical, Social, and Multimodal Interventions on Quality of Life, Social Isolation, and Stigma among Individuals with MCI or Dementia |
| Date of disclosure of the study information | 2025/11/23 |
| Last modified on | 2025/11/23 23:32:48 |
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Basic information
Public title
A Parallel-Group Randomized Controlled Trial to Evaluate the Effects of eSports and Technology-Based Cognitive, Physical, Social, and Multimodal Interventions on Quality of Life, Social Isolation, and Stigma among Individuals with MCI or Dementia
Acronym
A Parallel-Group Randomized Controlled Trial to Evaluate the Effects of eSports and Technology-Based Cognitive, Physical, Social, and Multimodal Interventions on Quality of Life, Social Isolation, and Stigma among Individuals with MCI or Dementia
Scientific Title
A Parallel-Group Randomized Controlled Trial to Evaluate the Effects of eSports and Technology-Based Cognitive, Physical, Social, and Multimodal Interventions on Quality of Life, Social Isolation, and Stigma among Individuals with MCI or Dementia
Scientific Title:Acronym
A Parallel-Group Randomized Controlled Trial to Evaluate the Effects of eSports and Technology-Based Cognitive, Physical, Social, and Multimodal Interventions on Quality of Life, Social Isolation, and Stigma among Individuals with MCI or Dementia
Region
| Japan |
Condition
Condition
Dementia, MCI, and Community-dwelling healthy adults
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether a cognitive, physical, and social combined intervention (digital health program) involving e-sports and digital device with intergenerational exchange with younger individuals improves feelings of self-esteem in individuals with MCI/dementia and community-dwelling older adults, compared to a standard cognitive, physical, and social combined intervention also involving intergenerational exchange with younger individuals
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rosenberg's Self Esteem Scale after 4 Weeks of Intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Participants will engage in an intergenerational multimodal program that includes eSports once a week for 80 minutes for a total of four sessions Figure 2 along with interaction through tablet based applications iPad on the remaining days Figures 3 and 4 Instruction on iPad operation will be provided during each program session and the program will incorporate cognitive physical and social multimodal interventions that include elements such as cognitive stimulation exercise and nutritional guidance Figure 1 eSports activities will be conducted using the Nintendo Switch Nintendo The software used will include Taiko no Tatsujin 1 2 Switch Fishing Spirits Switch Sports and WarioWare selected from programs previously offered to community dwelling older adults at Kinjo University and evaluated as conducive to intergenerational interaction between older adults and healthy young adults.
For the interaction through iPad applications, the development of the application will be outsourced to Dynacom Co., Ltd. Under the guidance of Yoshimura, a specialist in communication for individuals with dementia, the application will be designed to minimize long text reading and complex, which are often difficult for people with dementia. Training on how to use the iPad and the application will be provided within the multimodal program. At home, with family support, participants will interact with healthy young adults via the application approximately once per day, at least three days per week. The time period for iPad-based interaction will be set between 7:00 and 19:00, during which participants will check and reply to messages at their convenience.
Interventions/Control_2
A multimodal intergenerational program without eSports will be conducted once a week for 80 minutes, for a total of four sessions (Figure 2). No additional interactions on other days, such as electronic device based communication, will be provided. The program will include cognitive, physical, and social multimodal interventions incorporating elements such as cognitive stimulation, exercise, and nutritional guidance.
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Individuals with MCI or dementia (National Center for Geriatrics and Gerontology)
Aged 65 years or older
2. Older adults (Kinjo University)
Aged 65 years or older
3. Healthy young adults (National Center for Geriatrics and Gerontology / Kinjo University)
Aged 18 to under 45 years
No clinical experience in providing care for individuals with MCI or dementia, or less than 6 months of such experience
Key exclusion criteria
1. Individuals with MCI or dementia (National Center for Geriatrics and Gerontology)
Individuals who cannot understand the program content
Individuals restricted from participating in physical activity or similar interventions by their primary care physician due to underlying medical conditions
Individuals with language impairments that make communication difficult
Individuals who are unable to remain seated during the program sessions
Individuals with severe dementia (Clinical Dementia Rating: CDR 3)
2. Older adults (Kinjo University)
Individuals who cannot understand the program content
Individuals restricted from participating in physical activity or similar interventions by their primary care physician due to underlying medical conditions
Individuals with language impairments that make communication difficult
Individuals who are unable to remain seated during the program sessions
3. Healthy young adults (National Center for Geriatrics and Gerontology / Kinjo University)
Individuals restricted from participating in physical activity or similar interventions by their primary care physician due to underlying medical conditions
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Aiko |
| Middle name | |
| Last name | Osawa |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Rehabilitation Medicine
Zip code
474-8511
Address
7-430, Morioka, Obu, Aichi
TEL
0562-46-2311
aiko_o_med@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Aiko |
| Middle name | |
| Last name | Osawa |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Rehabilitation Medicine
Zip code
474-8511
Address
7-430, Morioka, Obu, Aichi
TEL
0562-46-2311
Homepage URL
aiko_o_med@yahoo.co.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Aiko Osawa
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED) Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kinjo University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Geriatrics and Gerontology
Address
7-430, Morioka, Obu Aichi
Tel
0562-46-2311
yaday@ncgg.go.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
国立長寿医療研究センター（愛知県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | 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
108
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
| 2025 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 15 | 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 | 11 | Month | 23 | Day |
Last modified on
| 2025 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068443
