UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055651 |
|---|---|
| Receipt number | R000063601 |
| Scientific Title | The Effects of an Analog Game Program on Cognitive and Physical-Mental Functions |
| Date of disclosure of the study information | 2024/09/30 |
| Last modified on | 2024/09/27 18:07:58 |
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Basic information
Public title
The Effects of an Analog Game Program on Cognitive and Physical-Mental Functions
Acronym
The Effects of an Analog Game Program on Cognitive and Physical-Mental Functions
Scientific Title
The Effects of an Analog Game Program on Cognitive and Physical-Mental Functions
Scientific Title:Acronym
The Effects of an Analog Game Program on Cognitive and Physical-Mental Functions
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we aim to develop a program focused on analog games (board games and art card games) and evaluate its effectiveness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function
Key secondary outcomes
Physical - Mental function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
The implementation period for the Analog Game Program will be 10 weeks, with the first group participating in 120-minute sessions once a week for a total of 10 sessions. The program will be developed and executed by enhancing elements that suppress cognitive decline, based on the curricula of the Picture Book Reading Course and the Go Course, created by the Tokyo Metropolitan Institute of Gerontology's Research Team on Social Participation and Healthy Aging.
The program consists of 10 sessions, with sessions 1 to 6 primarily focused on board games and sessions 7 to 10 centered around art card games. Throughout all sessions, researchers and supporters experienced in facilitating analog games (both board games and art card games) and health lectures for the elderly will serve as facilitators. The analog games included in the board game program are believed to relate to areas such as complex attention, executive function, learning and memory, language, perceptual-motor skills, and social cognition, while also promoting cultural learning and intergenerational interaction through art card games.
In sessions 1 to 6, participants will engage in experiences with board games, with approximately 1 to 3 board games conducted per session, considering the load, difficulty, and relevant cognitive function areas. Sessions 7 to 10 will focus on art card games, including not only the experience of playing these games but also the opportunity for participants to devise their own new games and experience them firsthand.
Following this, participants will be required to attend health lectures. These lectures will be conducted once a month to prevent dropouts from the waiting group of the Analog Game Program, providing beneficial information related to health, focusing on themes such as exercise, mental health, and social participation.
Interventions/Control_2
The health lectures will be conducted once a month to prevent dropouts from the waiting group of the Analog Game Program, providing beneficial information related to health, focusing on themes such as "exercise," "mental health," and "social participation." Following this, participants will be required to enroll in the program.
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants aged 60 and older in the Analog Game Program
Key exclusion criteria
Participants who cannot obtain informed consent
Individuals deemed ineligible by the principal investigator or physician.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Suzuki |
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Division name
Research Team for Social Participation and Healthy Aging
Zip code
173-0015
Address
35-2 Sakae-cho,Itabashi-ku, Tokyo, Japan
TEL
03-3964-3241
suzukihy@tmig.or.jp
Public contact
Name of contact person
| 1st name | Daichi |
| Middle name | |
| Last name | Yamashiro |
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Division name
Research Team for Social Participation and Healthy Aging
Zip code
173-0015
Address
35-2 Sakae-cho,Itabashi-ku, Tokyo, Japan
TEL
03-3964-3241
Homepage URL
dymsr@tmig.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Address
35-2 Sakae-cho,Itabashi-ku, Tokyo, 173-0015,Japan
Tel
03-3964-3241
kouhou@tmghig.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
| 2024 | Year | 09 | Month | 30 | 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
| 2024 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 27 | Day |
Last modified on
| 2024 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063601
