Community-dwelling adults aged 60 to 80 years without dementia who are identified as having hypertension (systolic blood pressure >
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Individuals aged 60 to 80 years at the time of enrollment 2) Individuals with vascular risk factors, defined as hypertension (systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg) or hyperglycemia (HbA1c >=6.5%) 3) Individuals with a total score of 22 to 30 on the Dementia Assessment Sheet in Community-based Integrated Care System - 21 items (DASC-21) 4) Individuals who receive a full explanation of the study using the written informed consent form and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1) Individuals with severe functional impairment requiring prohibition or restriction of physical activity or dietary/fluid intake (including musculoskeletal disorders, renal failure, ischemic heart disease, or cardiopulmonary dysfunction). 2) Individuals with a diagnosed dementia 3) Individuals who are unable to communicate in Japanese 4) Individuals who are unable to undergo cognitive or physical assessments 5) Individuals who have been certified as needing long-term care at level 1 or higher under the Japanese Long-Term Care Insurance system 6) Individuals with a history of major depressive disorder, bipolar disorder, schizophrenia, alcohol dependence, drug dependence, or with unstable or severe medical conditions 7) Individuals deemed unsuitable for participation by their attending physician due to concerns such as potential worsening of underlying medical conditions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in MoCA-J score from baseline to the 12-month follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Changes in cognitive function (Nou-Know, MIRUDAKE) from baseline to 6, 12, and 24 months. 2) Changes in frailty status from baseline to 6, 12, and 24 months. 3) Changes in physical function (grip strength, gait speed, one-leg standing time) and physical activity levels from baseline to 6, 12, and 24 months. 4) Changes in dietary diversity score from baseline to 6, 12, and 24 months. 5) Changes in depressive symptoms (GDS) from baseline to 6, 12, and 24 months. 6) Changes in health-related quality of life (EQ-5D) from baseline to 6, 12, and 24 months. 7) Changes in health check-up results from screening to 12 months 8) Acceptability of the intervention, class attendance rate, and transition rate to self-organized groups at the end of the program 9) Changes in blood biomarkers from baseline to 12 months. 10) Cost-effectiveness | — |
Countries
Japan
Contacts
National Center for Geriatrics and Gerontology Department of Prevention and Care Science