Viability of an educational program for lifestyle changes and an algorithm for the derivation of exercise programs in...

This manuscript presents the study protocol of the PRICA-POWFRAIL randomized controlled trial. Frailty and pre-frailty are major predictors of functional decline and dependency in older adults, yet the implementation of personalized, scalable, and clinically interventions in primary care remains limited. This protocol describes the methodological design and planned evaluation of a lifestyle education programme and an individualized exercise-prescription algorithm aimed at improving intrinsic capacity and preventing dependency.

This is a multicentre, four-arm randomized controlled trial with a 10-week intervention period and a 12-month follow-up. A total of 110 adults aged ≥ 70 years identified as frail or pre-frail in primary care will be recruited and randomized (1:1:1:1) to one of four groups: (1) Education (EDU), (2) Exercise (EXER), (3) Combined Education-Exercise (EDU-EXER), or (4) Control. Primary outcomes include intrinsic capacity, physical function, and health-related quality of life. Secondary outcomes include digital mobility biomarkers, muscle and body composition measures, and blood-based biomarkers. A previous internal pilot study will inform final assumptions for sample size estimation.

This protocol outlines a theoretically grounded and clinically implementable model combining lifestyle education and an individualized exercise algorithm adapted to the primary care context in south Spain. The findings will provide evidence regarding the potential clinical impact of the PRICA-POWFRAIL approach and will inform future strategies for early individualized intervention in frailty and pre-frailty.

ClinicalTrials.gov Identifier: NCT05772910.