Tamba Active Mind and Bright Aging Study 3

JRCT ID: jRCT1050240132

Registered date:20/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Prevention of cognitive decline, mild cognitive impairment, and dementia
• Date of first enrollment: 20/09/2024
• Target sample size: 1200
• Study type: Interventional

Intervention(s)

Encourage participation in one of the following activities (for up to one year).
1) Exercise class (hybrid type, where participants gather at a meeting place and a trainer provides the program online) to be newly established in this study
2) Iki-Iki Hyakusai Exercise group
3) A voluntary group of J-MINT PRIME Tamba study participants (hybrid type, where participants gather at a meeting place and a trainer provides the program online)

Outcome(s)

• Primary Outcome: Compare the change in the composite score on the Nou-KNOW in the participating groups before and after the intervention

Secondary Outcome

Pre- and post-intervention comparisons for the participating groups only
1) Change in scores in each domain in the Nou-KNOW.
2) Change in scores for each item of the comprehensive functional assessment (QoL, frailty, etc.)
3) Change in each item of physical function and the Short Physical Performance Battery (SPPB) score
4) Changes in the level of long-term care insurance certification and the use of long-term care insurance and medical insurance

Comparison between participating and non-participating groups
1) Compare the changes in each of the assessment items

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: < 75age old
• Gender: Both

Include criteria

1) Tamba City residents who participated in the specified health checkups in Tamba City in FY2024 and who are between 40 and 75 years old at enrollment.
2) Individuals with any of the following vascular risk factors (hypertension and glucose intolerance)
Hypertension: Treated for hypertension, systolic blood pressure over 130 mmHg, or diastolic blood pressure over 85 mmHg
Impaired glucose tolerance: Treated for diabetes mellitus or HbA1c over 5.6%.
3) Individuals whose score on the Dementia Assessment Sheet for Community-based Integrated Care System-21 items (DASC-21) is between 22 and 30 points or those suspected of being pre-frailty.

Exclude criteria

1) Individuals who need to prohibit or restrict exercise, eating, or drinking water due to severe functional impairment
2) Individuals who have been diagnosed with dementia
3) Individuals with apparent cognitive decline
4) Individuals who are unable to converse in Japanese
5) Individuals who cannot undergo cognitive function tests, etc.
6) Individuals judged inappropriate as research participants by their attending physicians or family physicians

Related Information

• Primary Sponsor: Kowa Hisatomo
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development