UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062250 |
|---|---|
| Receipt number | R000071222 |
| Scientific Title | A Prospective Cohort Study on Older Adults and Community Vitality in Kawasaki City Kawasaki Mirai Active Project (K-MAP) |
| Date of disclosure of the study information | 2026/07/16 |
| Last modified on | 2026/07/15 19:23:49 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Prospective Cohort Study on Older Adults and Community Vitality in Kawasaki City
Kawasaki Mirai Active Project (K-MAP)
Acronym
Kawasaki Mirai Active Project (K-MAP)
Scientific Title
A Prospective Cohort Study on Older Adults and Community Vitality in Kawasaki City
Kawasaki Mirai Active Project (K-MAP)
Scientific Title:Acronym
Kawasaki Mirai Active Project (K-MAP)
Region
| Japan |
Condition
Condition
No restrictions (as this program is intended for older adults living in the area who are classified as requiring Support Level 1 or lower)
Classification by specialty
| Medicine in general | Surgery in general | Ophthalmology |
| Oto-rhino-laryngology | Orthopedics | Rehabilitation medicine |
| Adult |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to examine healthy Kawasaki residents aged 75-79 who do not require care in their daily lives (classified as 'independent' or 'Support Level 1'), by analyzing them from multiple perspectives, including the physical domain (medical care, long-term care), the psychological domain (well-being, cognitive function, depression), the lifestyle domain (dietary habits, exercise habits, sleep), environment and community (housing environment, neighborhood environment, and social participation), to identify the characteristics of this group of healthy older adults and the factors necessary for maintaining their health and vitality.
Basic objectives2
Others
Basic objectives -Others
This study builds upon previous research conducted on older cohorts, namely the Centenarian Study initiated in 2000, as well as the Kawasaki Aging and Well-being Project (KAWP), to predict aging using genomic biomarkers, to measure effects using longitudinal data collected via devices, and to elucidate the requirements for maintaining vitality from the perspectives of region, community, and environment, specifically, in terms of fostering a sense of purpose and well-being, and forming communities that include seniors who are physically and mentally healthy.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Referencing the WHO's ICOPE framework, we will develop a comprehensive index based on eight indicators: the six intrinsic capacities (cognitive function, motor function, vitality, vision, hearing, and enjoyment, the opposite of depressive tendencies) plus two functional abilities (social support and social network). The composite score of these eight vitality indicators will serve as the primary outcome measure for this prospective cohort study.
The survey items will be carefully selected from those scheduled for collection in the baseline survey.
Key secondary outcomes
Survey Items and Measurement Items in the Questionnaire
Certification of Long-Term Care Needs, Medical Expenses, and Long-Term Care Expenses Based on KDB Data
Various Indicators Derived from the Measurements
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 75 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The survey of older adults in the late elderly age group residing in the region targets individuals aged 75-79 who live in specific areas of Kawasaki City and do not receive daily living care (i.e., are independent or classified as "Support Level 1").
Participants must understand the nature of this study and have provided written consent.
The two-year follow-up survey, scheduled to begin in April 2028, will include participants from the baseline survey who do not meet the exclusion criteria.
Key exclusion criteria
(1) Individuals who are unable to travel to the survey site on their own
(2) Individuals who cannot understand the contents of the questionnaire
(3) Individuals with whom the interviewer cannot communicate effectively
(4) Individuals suffering from an acute illness
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Oguma |
Organization
Keio University
Division name
Sports Medicine Research Center
Zip code
2230061
Address
4-1-1 Hiyoshi, Kohoku-ku, Yokohama, Kanagawa JAPAN
TEL
045-566-1090
yoguma@keio.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Oguma |
Organization
Keio University
Division name
Sports Medicine Research Center
Zip code
2230061
Address
4-1-1 Hiyoshi, Kohoku-ku, Yokohama, Kanagawa JAPAN
TEL
045-566-1090
Homepage URL
yoguma@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
KISTEC
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB committee of Keio Medical School
Address
35 Shinanomachi, Shinjuku-ku, Tokyo JAPAN
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 16 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2034 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study aims to comprehensively assess the physical, psychological, lifestyle, and social environmental domains among community-dwelling adults aged 75-79 years and to identify the factors associated with maintaining good health. Based on the WHO's ICOPE framework, we will develop a novel "Genki Index" and examine the factors that support healthy longevity through a prospective cohort study.
Management information
Registered date
| 2026 | Year | 07 | Month | 15 | Day |
Last modified on
| 2026 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071222
