NCT07238556Recruiting
A Novel Digital Tool Clinicians Can Use to Prescribe Exercise to Patients With Cardiovascular Disease Risk Factors
Feasibility and Acceptability of a Novel Algorithm for Clinicians to Prescribe Personalized Exercise Prescriptions to Patients With Cardiovascular Disease Risk Factors: Study Protocol for an Exploratory Randomized Controlled Crossover Trial
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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 clinicians to use to Prioritize Personalize Prescribe EXercise (P3-EX) to patients with cardiovascular disease (CVD) risk factors. The investigators will recruit 24 clinicians, including physicians, physician assistants, or advanced practice registered nurses, from two local hospitals in CT, USA. Clinicians will recruit two patients each (N=48) having CVD risk factors. Clinicians 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. Clinicians 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 clinicians 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 clinicians to use to prescribe customized exercise routines for patients with CVD risk factors, and clinicians and patients will be satisfied with P3-EX.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 72 (estimated)
- First submitted
- 7 Nov 2025
- Start date
- 30 Mar 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- University of Connecticut
- Diseases
- Obesity, High blood pressure
- NCT number
- NCT07238556
What you commit to
- Study type: Interventional
- Planned participants: 72
- From 30 Mar 2026 to the primary completion date, 31 Dec 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Clinician Inclusion Criteria
- Practicing physicians, physician assistants, or advanced practice registered nurses employed at the study recruitment sites
- Do not recommend written exercise programs or plans to all their patients, nor refer all their patients 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.
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UConn Health Coordinator of this site? Confirm its status | Farmington | United States | Not yet recruiting |
| Hartford Healthcare Coordinator of this site? Confirm its status | Hartford | United States | Recruiting |
| University of Connecticut Coordinator of this site? Confirm its status | Storrs | United States | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.