Clinical Trial: 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 (Japan)

Tokyo, Nov. 24 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059864) titled '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' on Nov. 23.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - National Center for Geriatrics and Gerontology

Condition: Condition - Dementia, MCI, and Community-dwelling healthy adults Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

Eligibility: Age-lower limit - 18 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 Size - 100

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068443

Disclaimer: Curated by HT Syndication.