UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060358 |
|---|---|
| Receipt number | R000069025 |
| Scientific Title | Prognostic Factors for Subjective Health Perception in Community-Dwelling Older Adults: A Machine Learning-Based Analysis |
| Date of disclosure of the study information | 2026/03/01 |
| Last modified on | 2026/01/14 23:45:24 |
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Basic information
Public title
Prognostic Factors for Subjective Health Perception in Community-Dwelling Older Adults: A Machine Learning-Based Analysis
Acronym
Prognostic Factors for Subjective Health Perception in Community-Dwelling Older Adults
Scientific Title
Prognostic Factors for Subjective Health Perception in Community-Dwelling Older Adults: A Machine Learning-Based Analysis
Scientific Title:Acronym
Prognostic Factors for Subjective Health Perception in Community-Dwelling Older Adults
Region
| Japan | Australia |
Condition
Condition
Healthy older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify key factors contributing to the extension of healthy life expectancy by integratively analyzing longitudinal changes in self-rated health, cognitive function, and multidimensional indicators including metabolic biomarkers among community-dwelling older adults in Japan and Australia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in subjective health perception
Key secondary outcomes
1. Longitudinal change in cognitive function(The follow-up assessment will be conducted at least 6 months after the baseline assessment)
2. Changes in physical function
3. Brain MRI derived measures
4. Blood-based biochemical data
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
| 65 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. No history of psychiatric or neurological disorders
2. A person who signed a written informed consent
Key exclusion criteria
1. History of developmental disabilities or psychiatric disorders
2. MRI examinations are contraindicated for individuals with magnetic materials or implanted medical devices in their bodies, as well as those with claustrophobia.
3. Individuals with evident neurological deficits attributable to stroke
4. Individuals with an increased risk of bleeding, a history of serious adverse events during blood sampling, skin infection or lesions at the venipuncture site, severe fear of blood sampling that precludes safe collection, or who are pregnant or may be pregnant
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | DAISUKE |
| Middle name | |
| Last name | SAWAMURA |
Organization
Faculty of Health Sciences, Hokkaido University
Division name
Rehabilitation Science
Zip code
060-0812
Address
Kita12-jo nishi5-chome Kita-ku Sapporo, Hokkaido, Japan
TEL
0117063387
D.sawamura@pop.med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | DAISUKE |
| Middle name | |
| Last name | SAWAMURA |
Organization
Faculty of Health Sciences, Hokkaido University
Division name
Rehabilitation Science
Zip code
060-0812
Address
Kita12-jo nishi5-chome Kita-ku Sapporo, Hokkaido, Japan
TEL
0117063387
Homepage URL
D.sawamura@pop.med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
DAISUKE SAWAMURA
Funding Source
Organization
Hokkaido University
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
Ethics Committee of the Faculty of Health Sciences at Hokkaido University
Address
Kita12-jo nishi5-chome Kita-ku Sapporo, Hokkaido, Japan
Tel
011-706-3316
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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 01 | 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
| 2026 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2028 | 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 will employ a prospective longitudinal design. Physical function,cognitive function, and subjective health perception will be assessed. Physical function will be evaluated using maximum 5m walking speed, the five times sit to stand test, the Timed Up and Go test, handgrip strength, and static and dynamic standing balance indices measured with a stabilometer. Cognitive function will be assessed using the Montreal Cognitive Assessment, Digit Span, the Paced Auditory Serial Addition Test, and the Symbol Digit Modalities Test. Subjective health perception will be evaluated using the Questionnaire for the Elderly, the Life Engagement Test, and the Meaning in Life Questionnaire short Form. Of the 250 participants, 50 will additionally undergo brain MRI examinations and blood sampling for biochemical analyses. Assessments will be conducted at two time points, with the follow up assessment performed at least six months after the baseline assessment.
Management information
Registered date
| 2026 | Year | 01 | Month | 14 | Day |
Last modified on
| 2026 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069025
