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

NCT07238556 | Recruiting DMC

• 3 other identifiers: E25-0518N/A (Internal Funding)E-HHC-2025-0198
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Hypertension; Dyslipidemia; Diabetes Mellitus; Obesity; Cardiovascular Disease

Keywords

Exercise prescription; Exercise Therapy; Physical Activity; Preventive Health Services; Health Behavior; Medical Informatics Applications; Health technology; Precision Medicine; Primary Health Care

Outcome Measures

Primary Outcomes (2)

• Feasibility and Acceptability of Prioritize Personalize Prescribe EXercise (P3-EX)

  The mHealth Application Usability Questionnaire is validated to measure the usability of mobile health apps for healthcare providers and/or patients through 21 items spilt into three subscales; Ease of Use and Satisfaction, System Information Arrangement, and Usefulness. The rating of each item is scaled from 1 to 7, and responses are averaged to provide a single score. Physicians will rate both P3-EX and American College of Sports Medicine Physical Activity Vital Sign (ACSM-PAVS), and patients will rate the one they receive. Overall scores (mean ± SD) will be compared to the middle score of 4.0.

  Within 48 hours following the delivery of P3-EX and ACSM-PAVS

• Feasibility and Acceptability of Prioritize Personalize Prescribe EXercise (P3-EX)

  The System Usability Scale is the most common questionnaire to assess the usability of mHealth apps. Ratings for each of the 10 items are scaled from 1 to 5. Physicians will rate both P3-EX and American College of Sports Medicine Physical Activity Vital Sign (ACSM-PAVS), and patients will rate the one they receive. Overall scores (mean ± SD) will be scaled from 0 to 100 and compared to normative reference ratings and scores in the literature.

  Within 48 hours following the delivery of P3-EX and ACSM-PAVS

Secondary Outcomes (15)

• Physician Barriers to and Confidence with Exercise Prescription (ExRx)

  Before completing brief ExRx training and within 48 hours following the delivery of either P3-EX or ACSM-PAVS

• American Heart Association Life's Essential 8 Score Change from Baseline

  12 weeks

• Resting Blood Pressure Changes

  12 weeks

• Resting Heart Rate Changes

  12 weeks

• Body Mass Index Changes

  12 weeks

Other Outcomes (3)

• Fidelity of Prioritize Personalize Prescribe Exercise (P3-EX)

  Throughout the 5-month study, at each physicians' use of P3-EX to deliver an exercise prescription to a patient in the study (assessed once per physician; anticipated 19-24 physicians)

• Usage Time of Prioritize Personalize Prescribe Exercise (P3-EX and ACSM-PAVS)

  Throughout the 5-month study, at each physicians' use of P3-EX and ACSM-PAVS to deliver an exercise prescription to a patient in the study (assessed once per physician; anticipated 19-24 physicians)

• Trial Satisfaction

  Within 48 hours after completing the delivery of both P3-EX and ACSM PAVS

Study Arms (2)

Prioritizes Personalizes Prescribes EXercise (P3-EX)

EXPERIMENTAL

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.

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

American College of Sports Medicine Physical Activity Vital Sign (ACSM-PAVS)

ACTIVE COMPARATOR

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.

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

Interventions

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

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.

American College of Sports Medicine Physical Activity Vital Sign (ACSM-PAVS)

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

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.

Prioritizes Personalizes Prescribes EXercise (P3-EX)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Practicing medical doctors employed at the study recruitment sites
• Do not recommend written exercise programs or plans to their patients, nor refer them to exercise clinics or exercise professionals
• Are willing to recruit two of their patients to deliver Prioritize Personalize Prescribe EXercise (P3-EX) and American College of Sports Medicine Physical Activity Vital Sign (ACSM PAVS)
• Sedentary: have not performed planned, structured physical activity at moderate intensity for ≥30 minutes on ≥3 days per week in the last 3 months
• Adults: ≥18 and ≤64 yrs
• ≥1 cardiovascular disease risk factors: Having obesity, hypertension, dyslipidemia, and/or diabetes (or prediabetes)
• Obesity: BMI ≥30 kg/m2 or WC \>102 cm (40 in) for men and \>88 cm (35 in) for women
• Hypertension: Systolic BP ≥130 mm Hg and/or diastolic BP ≥80 mm Hg, or on antihypertensive medication
• Dyslipidemia: LDL-C ≥130 mg/dL (3.37 mmol/L), or HDL-C \<40 mg/dL (1.04 mmol/L) in men and \<50 mg/dL (1.3 mmol/L) in women, or non-HDL-C ≥160 mg/dL (4.14 mmol/L), or on lipid-lowering medication, or TC ≥200 mg/dL (5.18 mmol/L)
• Diabetes (or prediabetes): FBG ≥100 mg/dL or HbA1c ≥5.7%, or on medication for diabetes
• Healthy: Having no signs or symptoms of or have cardiovascular or renal disease, or other diseases or health conditions that significantly limit physical activity engagement
• Not pregnant or lactating
• Not a cigarette smoker or quit smoking ≥6 months ago
• Consume \<2 alcoholic drinks daily
• Able to use a computer or phone with internet access

Sponsors & Collaborators

• University of Connecticut: lead
• Hartford HealthCare: collaborator
• UConn Health: collaborator

Study Sites (3)

UConn Health

Farmington, Connecticut, 06030, United States

NOT YET RECRUITING

Hartford HealthCare

Hartford, Connecticut, 06102, United States

RECRUITING

University of Connecticut

Storrs, Connecticut, 06269, United States

RECRUITING

Related Publications (5)

• Zaleski AL, Berkowsky R, Craig KJT, Pescatello LS. Comprehensiveness, Accuracy, and Readability of Exercise Recommendations Provided by an AI-Based Chatbot: Mixed Methods Study. JMIR Med Educ. 2024 Jan 11;10:e51308. doi: 10.2196/51308.

  PMID: 38206661 BACKGROUND

• Chen S, Wu Y, Kennedy J, Panza G, Guidry MZ, Pescatello LS; FACSM. An exercise prescription algorithm for clinicians to use with their patients with cardiovascular disease risk factors. Digit Health. 2025 Jul 16;11:20552076251360884. doi: 10.1177/20552076251360884. eCollection 2025 Jan-Dec.

  PMID: 40677518 BACKGROUND

• Chen S, Wu Y, Bushey EL, Pescatello LS. Evaluation of Exercise Mobile Applications for Adults with Cardiovascular Disease Risk Factors. J Cardiovasc Dev Dis. 2023 Nov 28;10(12):477. doi: 10.3390/jcdd10120477.

  PMID: 38132645 BACKGROUND

• Pescatello LS, Wu Y, Panza GA, Zaleski A, Guidry M. Development of a Novel Clinical Decision Support System for Exercise Prescription Among Patients With Multiple Cardiovascular Disease Risk Factors. Mayo Clin Proc Innov Qual Outcomes. 2020 Oct 22;5(1):193-203. doi: 10.1016/j.mayocpiqo.2020.08.005. eCollection 2021 Feb.

  PMID: 33718793 BACKGROUND

• Wright AJ, Panza GA, Fernandez AB, Robinson PF, DeScenza VR, Chen MH, Lee EC, Guidry MA, Pescatello LS. 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. Healthcare (Basel). 2026 Jan 12;14(2):188. doi: 10.3390/healthcare14020188.

  PMID: 41595324 DERIVED

MeSH Terms

Conditions

Hypertension; Dyslipidemias; Diabetes Mellitus; Obesity; Cardiovascular Diseases; Motor Activity; Health Behavior

Condition Hierarchy (Ancestors)

Vascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Linda S Pescatello, PhD

  Department of Kinesiology, University of Connecticut

  PRINCIPAL INVESTIGATOR

• Antonio B Fernandez, MD

  Hartford HealthCare Heart & Vascular Institute, Hartford Hospital

  PRINCIPAL INVESTIGATOR

• Gregory Panza, PhD

  Department of Research Administration, Hartford HealthCare

  STUDY DIRECTOR

Central Study Contacts

Alexander J Wright, MS

CONTACT

(860) 486-6814; Alexander.Wright@hhchealth.org

Linda S Pescatello, PhD

CONTACT

(860) 486-0008; linda.pescatello@uconn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Outcome assessors (Graduate Research Assistants) of vitals, body composition, and physical activity levels will be blinded to intervention assignments at baseline. Outcome assessors (laboratory technicians) of blood lipid-lipoprotein and blood glucose profiles will be blinded to intervention assignments. The healthcare providers (physicians) who will deliver the intervention, the participants (patients) who receive the intervention; and the investigators (Graduate Research Assistants) who will provide exercise intervention oversight will have knowledge of will intervention assignment due to feasibility and the behavioral nature of the trial.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Board of Trustees Distinguished Professor

Model Details: Physicians (N=24) will deliver a Prioritized Personalized EXercise Prescription (P3-EX) to one of their patients with cardiovascular disease risk factors (n=24) and the American College of Sports Medicine Physical Activity Vital Sign exercise program to the other with cardiovascular disease risk factors (n=24) in random sequence.

Study Record Dates

• First Submitted: November 7, 2025
• First Posted: November 20, 2025
• Study Start: March 30, 2026
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: All de-identified IPD will be available upon reasonable request with no time limit.
• Access Criteria: All de-identified IPD will be shared via email to researchers who reasonably request the dataset.

Locations

US (3)