Feasibility and Acceptability of a Novel Algorithm for Physicians to Prescribe Personalized Exercise Prescriptions to Patients with Cardiovascular Disease Risk Factors: Study Protocol for an Exploratory Randomized Controlled Crossover Trial

TL;DR

This study tests a new digital tool for doctors to prescribe personalized exercise to patients with heart disease risk factors.

Contribution

The study introduces and evaluates a novel algorithm (P3-EX) for personalized exercise prescriptions in clinical practice.

Findings

The study will assess the feasibility and acceptability of the P3-EX algorithm among physicians and patients.

Patient cardiovascular risk factors and physical activity will be measured before and after a 12-week exercise intervention.

Results will inform the potential of P3-EX as a digital health tool to improve cardiovascular health.

Abstract

Background: Approximately half of U.S. adults have ≥1 cardiovascular disease (CVD) risk factors. Exercise is universally recommended as a first-line lifestyle therapy to prevent and treat CVD. Objective: We will conduct a feasibility and pilot efficacy randomized controlled trial to test the usability and user satisfaction of an evidence-based digital health tool we developed for physicians—the Prioritizes Personalizes Prescribes EXercise algorithm (P3-EX)—to treat patients with CVD risk factors (ClinicalTrials.gov: NCT07238556). Methods: We will recruit 24 physicians who do not prescribe written exercise prescriptions (ExRx) from two local CT hospitals. Physicians will recruit two patients each (N = 48); both patients must have CVD risk factors. Each physician will deliver a P3-EX ExRx to one patient (n = 24) and the Physical Activity Vital Sign ExRx to the other patient (n = 24) in a random sequence crossover design. Physicians and patients will rate the feasibility and acceptability of each ExRx method using validated questionnaires. Patients will perform their ExRx for 12 weeks and complete an exercise diary to monitor exercise adherence with weekly virtual oversight by Research Assistants. Before and after the exercise intervention, we will measure patient CVD risk factors and physical activity levels via accelerometry. Results: This trial has received Institutional Review Board approval (E-HHC-2025-0198) and will begin in January 2026, with findings published in 2027. Conclusions: This protocol provides the scientific rationale and methodology to test P3-EX within a real-world clinical setting, to inform the feasibility of using P3-EX as a digital health support tool by physicians, and preliminary efficacy of P3-EX to improve patient cardiovascular health and physical activity levels.

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