LEAP! Rx: A randomized trial of a pragmatic approach to lifestyle medicine

Abstract

Introduction: Clinicians lack the tools to incorporate physical activity into clinical care for Alzheimer's disease prevention. We tested a 52-week exercise and health education program (Lifestyle Empowerment for Alzheimer's Prevention [LEAP! Rx]) that integrates clinician referrals and community-based fitness resources.

Methods: We randomized 219 participants to the LEAP! Rx (ie, exercise and monthly brain health education) or a standard-of-care control group and tested the effects on cardiorespiratory fitness, insulin resistance, body composition, lipids, and cognitive performance.

Results: Physicians were able to connect their patients to a community lifestyle intervention. The intervention group increased in cardiorespiratory fitness at 12 and 52 weeks (p = 0.005). We observed no effects on secondary measures. Participants meeting 80% of weekly goals (150 min, moderate to vigorous activity) saw greater fitness improvements than those with less than 80% (p < 0.001).

Discussion: These results hold promise for broad implementation of exercise interventions into larger healthcare systems and have implications for improved research recruitment strategies.

Trial registration: NCT No. NCT03253341.

Highlights: Our community-based exercise program increased cardiorespiratory fitness. Our digital physician referral method increased the diversity of the participant sample. Our findings have implications for personalized dementia risk reduction strategies.

Keywords: cardiorespiratory fitness; exercise; exercise prescription; health care delivery; healthy lifestyle; intervention; physical activity; randomized controlled trial (RCT); recruitment.

FIGURE 1

Best practice alerts example.

FIGURE 2

CONSORT diagram.

FIGURE 3

Exercise increases fitness over 1‐year compared to waitlist.