Effects of the Combined Intervention of Exercise, Fruit, and Vitamin Supplementation on Frailty in Older Adults (EFVF): Rationale, Design, and Methods

Abstract

Background Frailty is a complex, dynamic, age-related clinical condition. Muscle strength, a critical indicator of frailty, decreases with advancing age. It is not known whether community-dwelling older adults with frailty modifiable risk factors, such as low levels of physical activity and fruit intake, might benefit from lifestyle interventions at both population and individual levels. Methods EFVF is a cluster-randomized trial including older individuals aged 65–80 years old with low levels of physical activity and fruit intake living in eastern China. Totally 14 villages will be randomized into 2 arms with 1:1 ratio, overall including ≥ 934 participants. Participants in the intervention arm will receive the combined intervention of physical activity, fruit, and vitamin supplementation 3 times a week for 2 months (the 1st and 6th months). Standardized health education and communication sessions will be conducted as well. Participants in the control arm will not receive any intervention. The primary outcome is the change in handgrip strength at 12 months from baseline. Secondary outcomes include handgrip strength, frailty index, lipid parameters, fasting blood glucose, and a composite of all-cause death or hospitalization for myocardial infarction, angina, or stroke. The study also includes an assessment of the cultivation of physical activity and fruit intake habits, as well as an economic evaluation. Discussion The study will target older adults with modifiable risk factors for frailty, to investigate whether the combined intervention might limit the decline of grip strength, frailty progression, and reduce the incidence of adverse events. If effective, it could provide a well-established and cost-effective strategy for frailty prevention in community settings. Trial registration: Clinical Trails.gov PRS Protocol Registration and Results System, NCT06225271, (Jan 17, 2024).