NCT07238556 · University of Connecticut
A Novel Digital Tool Physicians Can Use to Prescribe Exercise to Patients With Cardiovascular Disease Risk Factors
(P3-EX)
What this study is about
The investigators will conduct a feasibility and pilot effectiveness randomly assigned 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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) Patient Inclusion Criteria
- 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
- Fluent in English
- Willing to maintain their medication routine and habitual diet and not follow other exercise or nutrition programs. Patient
Exclusion criteria
- 4a. Have pain or discomfort in the chest, neck, jaw, or arms; dizziness or syncope; shortness of breath at rest or with mild exertion; unusual fatigue or shortness of breath with usual activities; orthopnea; ankle edema; intermittent claudication; palpitations; or known heart murmur 4b. Stroke or cancer survivors or currently have cancer, chronic obstructive pulmonary disease, musculoskeletal injury, chronic back pain, depression, dementia, or other diseases or health conditions that are deemed to significantly limit physical activity engagement.
Where
- Farmington, Connecticut
- Hartford, Connecticut
- Storrs, Connecticut
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 15, 2026 · Source of record for eligibility and locations