Tamba Active Mind and Bright Aging Study 2

JRCT ID: jRCT1050240072

Registered date:21/06/2024

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: 21/06/2024
• Target sample size: 500
• Study type: Interventional

Intervention(s)

Both the intervention and control groups continue to participate in the Iki-Iki Hyakusai Exercise that they have been participating in since before the study began.
Participants in the intervention group receive the following additional programs for one year.
1) Synapsology focuses on hand movements performed sitting to stimulate visual and verbal memory.
2) Aerobic exercise combining steps and upper limb movements for visual and auditory stimulation
3) Cogniladder combines exercise and cognitive tasks while using a ladder to stimulate spatial awareness and verbal recall.
Participants in the control group receive periodic health information pamphlets over one year.

Outcome(s)

• Primary Outcome: Changes in the Nou-KNOW composite scores from baseline to 12 months

Secondary Outcome

1) Changes in the Nou-KNOW each domain score from baseline to 12 months
2) Changes in the Nou-KNOW composite scores and each domain score from 12 months to 18 months
3) Changes in each item score of the comprehensive functional assessment (QoL, frailty, etc.)
4) Changes in each item of physical function and Short Physical Performance Battery (SPPB) scores

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: < 86age old
• Gender: Both

Include criteria

1) Tamba City residents between 65 and 86 years old at enrollment
2) Individuals who have participated in the Iki-Iki Hyakusai Exercise in Tamba City

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