UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056137 |
|---|---|
| Receipt number | R000064142 |
| Scientific Title | Feasibility and Preliminary Effects of a Cognitive Intervention Program Using the Pair Go Game: An Exploratory Study |
| Date of disclosure of the study information | 2024/11/13 |
| Last modified on | 2024/11/13 06:14:45 |
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Basic information
Public title
Research on Feasibility and Preliminary Effects of the Pair Go Program
Acronym
Research on the Pair Go Program
Scientific Title
Feasibility and Preliminary Effects of a Cognitive Intervention Program Using the Pair Go Game: An Exploratory Study
Scientific Title:Acronym
Intervention Study Using Pair Go
Region
| Japan |
Condition
Condition
Community-dwelling older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop a cognitive intervention program using Pair Go on the feasibility of the program and its preliminary effects on cognitive function mental health, and social network.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Executive function
Key secondary outcomes
Cognitive test battery, Depression, Feeling of Loneliness, Social network, Satisfaction of the program, The rates of attendance, The rates of dropout, The reasons for dropout, Willingness to continue playing Pair Go, Go Skills
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participatns attend 12 sessions of the Pair Go program once a week for 90 minutes per session.
Interventions/Control_2
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
aged 65 or more, being able to perform daily living activities independently, having no experience in Go
Key exclusion criteria
medical and psychiatric disorders affecting cognitive function, visual or hearing loss affecting daily life, diagnosis of dementia
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Ai |
| Middle name | |
| Last name | Iizuka |
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Division name
Research Team for Social Participation and Healthy Aging
Zip code
1730004
Address
8F Itabashi center building, 3-9-7, Itabashi, Itabashi City, Tokyo, Japan
TEL
03-6905-6781
aiizuka@tmig.or.jp
Public contact
Name of contact person
| 1st name | Ai |
| Middle name | |
| Last name | Iizuka |
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Division name
Research Team for Social Participation and Healthy Aging
Zip code
1730004
Address
8F Itabashi center building, 3-9-7, Itabashi, Itabashi City, Tokyo, Japan
TEL
03-6905-6781
Homepage URL
aiizuka@tmig.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
The Japan Pair Go Association
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
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Address
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Tel
03-6905-6781
k_itou@tmig.or.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 | 11 | Month | 13 | 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
23
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
| 2023 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 11 | 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
| 2024 | Year | 11 | Month | 13 | Day |
Last modified on
| 2024 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064142
