Effectiveness of the KENKOJISEICHI local revitalization system on cognitive function change in older adults with mild cognitive impairment: study protocol for a randomized controlled trial.

Background: Physical activity is associated with a lower risk of cognitive decline in older adults. However, past studies have demonstrated that older adults tend to relapse into inactivity after completing interventions. This ongoing study employs a randomized controlled trial design to assess the efficacy and efficiency of the KENKOJISEICHI local revitalization system for promoting daily outdoor behaviors to improve cognitive function in community-dwelling older adults with mild cognitive impairment (MCI).

Methods/design: This 6-month randomized controlled trial will include 83 community-dwelling older adults aged 65 years or older with MCI. Participants will be randomized to the KENKOJISEICHI experimental group or an educational control group. The KENKOJISEICHI group will receive a 90-minute session twice per week that consists of social, intellectual, and physical activities involving outdoor behaviors intended to support cognitive function. Participants in the educational control group will attend two 120-minute educational classes during the 6-month trial period. Considering a 20-30% dropout rate, a sample size of 35 participants per group is required.

Discussion: If the program successfully promotes long-term habitual outdoor behaviors, this will expand knowledge regarding how to support social, intellectual, and physical activities, as well as communication change, among the older population to provide them with cognitive benefits.

Trial Registration: University Hospital Medical Information Network (UMIN), Japan, UMIN000026479 . Registered on 9 March 2017.