Digital Exercise Prescription Tool for Cardiovascular Disease

(P3-EX Trial)

Not yet recruiting at 2 trial locations

Overseen By Linda S Pescatello, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Connecticut

Disqualifiers: Cancer, Stroke, COPD, Depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital tool called P3-EX, which helps doctors create personalized exercise plans for patients with cardiovascular disease (CVD) risk factors. It compares a customized exercise prescription with a standard exercise plan to determine which is more effective and user-friendly. Suitable participants include those who have been mostly inactive for the last three months and have at least one CVD risk factor, such as obesity, high blood pressure, or diabetes. Participants will follow their exercise plan for 12 weeks, and researchers will monitor their progress to assess if the customized plan offers better results. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance personalized exercise plans for those at risk of CVD.

Will I have to stop taking my current medications?

No, you won't have to stop taking your current medications. The trial requires you to maintain your medication routine and habitual diet.

What prior data suggests that this digital exercise prescription tool is safe for patients with cardiovascular disease risk factors?

Research shows that P3-EX is a popular tool for recommending exercise to people with heart disease risk factors. Studies have found that healthcare providers consider P3-EX easy to use and effective at creating personalized exercise plans. Importantly, this tool includes health checks to ensure patient safety before starting exercise. It assesses whether a patient needs a doctor's approval before beginning the routine.

Overall, P3-EX is designed to be safe and helpful for patients with heart disease risk factors. Studies have not reported any negative side effects, suggesting it is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial of the P3-EX digital exercise prescription tool because it offers a personalized approach to managing cardiovascular disease (CVD) risk factors, unlike the traditional one-size-fits-all exercise recommendations. P3-EX uses an evidence-based system to prioritize and tailor exercise prescriptions based on individual CVD risk factors, focusing on the patient's unique health profile. This personalized method aims to optimize cardiovascular health outcomes by addressing the most critical risk factors for each patient. In comparison, the alternative ACSM-PAVS approach provides a more generic exercise program that follows broad guidelines, lacking the customization that P3-EX offers.

What evidence suggests that this digital exercise prescription tool is effective for cardiovascular disease?

Research has shown that doctors find the P3-EX tool, which participants in this trial may receive, easy to use and effective in creating personalized exercise plans for patients with heart disease risk factors. This tool helps doctors design exercise routines tailored to each patient's unique health needs, potentially improving heart health. By evaluating patients' risk factors and suggesting specific exercises, it may be more effective than general exercise advice. The P3-EX tool targets the most important risk factors, helping patients focus on what matters most for their heart health. Early findings suggest that this personalized approach to exercise could lead to better health outcomes for those at risk of heart disease. ^{1 2 3 5 6}

Who Is on the Research Team?

Linda S Pescatello, PhD

Principal Investigator

Department of Kinesiology, University of Connecticut

Antonio B Fernandez, MD

Principal Investigator

Hartford HealthCare Heart & Vascular Institute, Hartford Hospital

Gregory Panza, PhD

Principal Investigator

Department of Research Administration, Hartford HealthCare

Are You a Good Fit for This Trial?

This trial is for patients with cardiovascular disease risk factors such as diabetes, hypertension, dyslipidemia, obesity, and high cholesterol. Participants will be recruited by physicians from two hospitals in Connecticut. Each physician recruits two patients to join the study.

Inclusion Criteria

Physician must be a practicing medical doctor employed at the study recruitment sites

Physician must not recommend written exercise programs or plans to their patients, nor refer them to exercise clinics or exercise professionals

Patient must be sedentary: have not performed planned, structured physical activity at moderate intensity for ≥30 minutes on ≥3 days per week in the last 3 months

Exclusion Criteria

I do not experience chest pain, dizziness, unusual fatigue, or other listed symptoms.

I do not have a history of stroke, cancer, or conditions limiting my physical activity.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

2 visits (in-person)

Training and Orientation

Physicians attend a virtual study orientation to provide informed consent, confirm eligibility, complete demographics, assess barriers to and confidence with ExRx, and receive brief ExRx delivery training.

1 week

1 visit (virtual)

Exercise Prescription and Intervention

Patients receive either a P3-EX or ACSM-PAVS exercise prescription and perform their prescribed exercise routine for 12 weeks with virtual oversight.

12 weeks

2 visits (virtual), weekly email updates

Follow-up

Participants are monitored for changes in CVD risk factors and physical activity levels post-intervention.

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• P3-EX

Trial Overview

The trial tests a digital health tool for prescribing exercise: P3-EX versus ACSM-PAVS. Both involve a 12-week unsupervised exercise program with virtual oversight. The goal is to see if these tools are user-friendly and effective at improving cardiovascular health and physical activity levels.

How Is the Trial Designed?

Group I: Prioritizes Personalizes Prescribes EXercise (P3-EX) Experimental Treatment 1 Intervention

Physicians will use Prioritizes Personalizes Prescribes Exercise (P3-EX), hosted by a web-based platform, to deliver P3-EX, an evidence-based personalized exercise prescription to improve cardiovascular disease (CVD) risk factors. P3-EX will determine whether the patient needs medical clearance. P3-EX will score the patient's CVD risk factors using an adapted American Heart Association Life's Essential 8 cardiovascular health scoring system to determine the CVD risk factor posing the greatest risk. If ≥2 CVD risk factors are tied for the greatest risk, P3-EX will prompt the physician to choose an American College of Sports Medicine strategy to prioritize one CVD risk factor to personalize the Frequency, Intensity, Time, and Type (FITT) exercise prescription. P3-EX will also produce special exercise considerations for the prioritized CVD risk factor. The physician will print the exercise prescription and give it to the patient to perform for 12 weeks.

Group II: American College of Sports Medicine Physical Activity Vital Sign (ACSM-PAVS) Active Control 1 Intervention

Physicians will use a hard copy instruction manual adapted from the Exercise is Medicine HealthCare Providers' Action Guide to deliver the American College of Sports Medicine Physical Activity Vital Sign (ACSM-PAVS), a generic exercise program to improve general health. The physician will ask the patient exercise preparticipation health screening questions to determine whether medical clearance is needed. The physician will assess their patient's physical activity levels as a vital sign (i.e., minutes per week of moderate to vigorous intensity exercise and days per week of resistance exercise). The physician will give the patient the ACSM-PAVS exercise program as a handout, which recommends the Physical Activity Guidelines for Americans of 150 minutes per week of moderate and/or 75 minutes per week of vigorous intensity aerobic exercise (or a combination) and 2 days per week of muscular strengthening exercise.

Who Is Running the Clinical Trial?

University of Connecticut

Lead Sponsor

Trials

194

Recruited

162,000+

Hartford HealthCare

Collaborator

Trials

9

Recruited

1,300+

UConn Health

Collaborator

Trials

218

Recruited

59,100+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07238556

A Novel Digital Tool Physicians Can Use to Prescribe ...

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 ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12268123/

An exercise prescription algorithm for clinicians to use with ...

We found healthcare providers are satisfied with P3-EX and agreed that it is a usable ExRx tool for patients with CVD risk factors. Our results ...

3.

p3-ex.com

p3-ex.com/research

Research

Discover P3-EX a novel tool to help clinicians prioritize, personalize, and prescribe exercise for patients with cardiovascular risk factors.

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S2542454820301570

Development of a Novel Clinical Decision Support System ...

We developed a novel clinical decision support system to prescribe exercise (prioritize personalize prescribe exercise [P3-EX]) for patients with multiple CVD ...

5.

researchgate.net

researchgate.net/publication/393752754_An_exercise_prescription_algorithm_for_clinicians_to_use_with_their_patients_with_cardiovascular_disease_risk_factors

(PDF) An exercise prescription algorithm for clinicians to ...

Conclusion We found healthcare providers are satisfied with P3-EX and agreed that it is a usable ExRx tool for patients with CVD risk factors.

6.

journals.sagepub.com

journals.sagepub.com/doi/abs/10.1177/20552076251360884

An exercise prescription algorithm for clinicians to use with ...

We found healthcare providers are satisfied with P3-EX and agreed that it is a usable ExRx tool for patients with CVD risk factors. Our results ...