RecruitingNot ApplicableNCT07238556

A Novel Digital Tool Physicians Can Use to Prescribe Exercise to Patients With Cardiovascular Disease Risk Factors

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

Sponsor

University of Connecticut

Enrollment

72 participants

Start Date

Mar 30, 2026

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus Obesity Hypertension Cardiovascular Disease Dyslipidemia

Summary

The investigators will conduct a feasibility and pilot efficacy randomized controlled trial to test the usability and user satisfaction of an evidence-based digital health tool the investigators developed for physicians to use to Prioritize Personalize Prescribe EXercise (P3-EX) to patients with cardiovascular disease (CVD) risk factors. The investigators will recruit 24 physicians from two local hospitals in CT, USA. Physicians will recruit two patients each (N=48) having CVD risk factors. Physicians will deliver a P3-EX exercise prescription (ExRx) to one of their patients (n=24) and the American College of Sports Medicine Physical Activity Vital Sign (ACSM-PAVS) ExRx to the other (n=24) in a random sequence crossover design. Physicians and patients will rate the feasibility and acceptability of each method using validated questionnaires. Patients will perform their prescribed ExRx for 12 weeks and complete a self-report exercise diary to monitor exercise adherence with virtual oversight from University of Connecticut (UConn) Graduate Research Assistants. Before and after the exercise intervention, the investigators will measure patient CVD risk factors and physical activity (PA) levels via accelerometry. The primary aim is to evaluate the feasibility and acceptability of P3-EX for physicians to use to prescribe exercise to patients with CVD risk factors, and the secondary aim is to explore the preliminary efficacy of P3-EX to improve patient CVD risk factors, PA levels, and exercise adherence. The investigators hypothesize P3-EX will be feasible for physicians to use to prescribe customized exercise routines for patients with CVD risk factors, and physicians and patients will be satisfied with P3-EX.

Eligibility

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a digital tool called P3-EX that helps doctors create personalized exercise plans for patients who have risk factors for heart disease. Researchers want to see if patients who receive a tailored exercise prescription from their doctor are more active than those who get standard advice. **You may be eligible if...** - You are an adult between 18 and 64 years old - You have been physically inactive (less than 30 minutes of moderate exercise 3 days a week) for the past 3 months - You have at least one heart disease risk factor: obesity, high blood pressure, high cholesterol, or diabetes (or prediabetes) - You have no current heart, kidney, or other serious disease that limits your ability to exercise - You are not pregnant or breastfeeding - You do not smoke (or have quit for at least 6 months) - You have access to a computer or phone with internet - You drink fewer than 2 alcoholic drinks per day **You may NOT be eligible if...** - You have chest pain, dizziness, shortness of breath at rest, swollen ankles, or other warning signs of heart disease - You have had a stroke or currently have cancer, COPD, chronic back pain, depression, or dementia - You follow another exercise or nutrition program Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALExperimental - 12 Week P3-EX Unsupervised Exercise Program with Virtual Weekly Oversight from Graduate Research Assistants

UConn Graduate Research Assistants will provide patients with virtual weekly oversight to follow their P3-EX unsupervised exercise program for 12 weeks. Patients will choose the location and the FITT of exercise they prefer. UConn Graduate Research Assistants will provide all patients with a 12-week exercise program information packet containing progressive FITT exercise recommendations for their exercise program. Patients will use an exercise diary called the Timeline Followback for Exercise to record the FITT of exercise daily. Patients will attend two virtual study visits led by UConn Graduate Research Assistants during the first week and midway through the intervention to receive standardized guidance on how they are doing following their exercise program. UConn Graduate Research Assistants will email all patients weekly to provide their progressive FITT exercise recommendations and summary reports of their Timeline Followback for Exercise recordings.

BEHAVIORALActive Control - 12 Week ACSM-PAVS Unsupervised Exercise Program with Virtual Weekly Oversight from Graduate Research Assistants

University of Connecticut (UConn) Graduate Research Assistants will provide patients with virtual weekly oversight to follow their ACSM-PAVS unsupervised exercise program for 12 weeks. Patients will choose the location and the FITT of exercise they prefer. UConn Graduate Research Assistants will provide all patients with a 12-week exercise program information packet containing progressive FITT exercise recommendations for their exercise program. Patients will use an exercise diary called the Timeline Followback for Exercise to record the FITT of exercise daily. Patients will attend two virtual study visits led by UConn Graduate Research Assistants during the first week and midway through the intervention to receive standardized guidance. UConn Graduate Research Assistants will email all patients weekly to provide their progressive FITT exercise recommendations and summary reports of their Timeline Followback for Exercise recordings.