UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058059 |
|---|---|
| Receipt number | R000066358 |
| Scientific Title | Effects of an Intergenerational Interaction Program Intervention on the Physical and Cognitive Function of Older Adults and College Students |
| Date of disclosure of the study information | 2025/06/07 |
| Last modified on | 2025/06/02 22:51:27 |
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Basic information
Public title
Intervention Effects of an Intergenerational Exchange Program on Community-Dwelling Older Adults and University Students:parallel-group trial
Acronym
Effects of Intergenerational Exchange Programs on the Elderly individuals and Young Adults
Scientific Title
Effects of an Intergenerational Interaction Program Intervention on the Physical and Cognitive Function of Older Adults and College Students
Scientific Title:Acronym
Effects of Intergenerational Exchange Program Intervention on the Physical and Cognitive Function of the Elderly individuals and Young Adults
Region
| Japan |
Condition
Condition
healthy older adults,healthy young adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of intergenerational exchange program intervention on the physical and cognitive function of the elderly individuals and young adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Physical and cognitive function
Key secondary outcomes
Self-efficacy, feeling of social connectedness
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
| Behavior,custom |
Interventions/Control_1
Intergenerational exchange programs(Gardening,etc.)
Interventions/Control_2
To not participate 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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy young adults
Older adults with or without disabilities
Key exclusion criteria
Individuals who are unable to make informed decisions
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yano |
| Middle name | |
| Last name | Rika |
Organization
Hokkaido University
Division name
Faculty of Health Sciences
Zip code
0600812
Address
N12-W5, Kita-ku, Sapporo, Hokkaido
TEL
0117063323
r-yano@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Yano |
| Middle name | |
| Last name | Rika |
Organization
Hokkaido University
Division name
Faculty of Health Sciences
Zip code
0600812
Address
N12-W5, Kita-ku, Sapporo, Hokkaido
TEL
0117063323
Homepage URL
r-yano@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
Faculty of Health Sciences, Hokkaido University
Address
Kita 12, Nishi 5, Kita-ku Sapporo, Hokkaido 060-0812, Japan
Tel
0117063315
shomu@hs.hokudai.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
北海道
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 07 | 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 | 06 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 08 | 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
| 2025 | Year | 06 | Month | 02 | Day |
Last modified on
| 2025 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066358
