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

Part of paid clinical trials in Farmington, Connecticut.

Sponsor
University of Connecticut
Study ID
NCT07238556
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Mar 30, 2026
Status verified
Apr 2026
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Prioritizes Personalizes Prescribes EXercise (P3-EX)
    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.
  • Active Comparator: American College of Sports Medicine Physical Activity Vital Sign (ACSM-PAVS)
    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.

Primary Outcome Measure

Feasibility and Acceptability of Prioritize Personalize Prescribe EXercise (P3-EX) [ Time Frame: Within 48 hours following the delivery of P3-EX and ACSM-PAVS ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
UConn HealthFarmingtonConnecticut06030
Peter F Robinson, MD
[email protected]
(860) 679-3343
Hartford HealthCareHartfordConnecticut06102
Antonio B Fernandez, MD
[email protected]
(860) 972-1695
University of ConnecticutStorrsConnecticut06269
Linda S Pescatello, PhD
[email protected]
(860) 486-0008

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