Digital tool for doctors to prescribe exercise for people with cardiovascular risk factors
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
This project will test whether a new digital tool helps doctors create personalized exercise plans for adults with cardiovascular risk factors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | University of Connecticut Academic / other |
| Locations | 3 sites (Farmington, Connecticut and 2 other locations) |
| Trial ID | NCT07238556 on ClinicalTrials.gov |
What this trial studies
This randomized, crossover pilot trial will enroll 24 physicians from three Connecticut sites and 48 of their adult patients with cardiovascular disease risk factors. Each physician will deliver a P3-EX personalized exercise prescription to one patient and the standard ACSM-PAVS prescription to their other patient in a randomized sequence, with patients following a 12-week unsupervised program and virtual weekly oversight. The trial will measure usability, acceptability, and feasibility from both physicians and patients using validated questionnaires and will track patient exercise adherence with a self-report diary. Results will inform whether the physician-facing digital decision support tool is practical and satisfactory in real-world clinical settings.
Who should consider this trial
Good fit: Adults aged 18–64 who are currently sedentary and have at least one cardiovascular risk factor (obesity, hypertension, dyslipidemia, or diabetes/prediabetes) are the intended participants.
Not a fit: Patients who are already meeting recommended activity levels, are outside the 18–64 age range, or who require medically supervised or closely monitored exercise programs are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the tool could help physicians give clearer, personalized exercise prescriptions that increase patient activity and may improve cardiovascular risk factors.
How similar studies have performed: Exercise prescriptions and digital health tools have shown promise for improving activity and risk factors, but physician-facing prescription decision-support tools like P3-EX remain relatively novel and have limited randomized pilot data.
Eligibility criteria
Show full inclusion / exclusion criteria
Physician Inclusion Criteria 1. Practicing medical doctors employed at the study recruitment sites 2. Do not recommend written exercise programs or plans to their patients, nor refer them to exercise clinics or exercise professionals 3. 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 1. Sedentary: have not performed planned, structured physical activity at moderate intensity for ≥30 minutes on ≥3 days per week in the last 3 months 2. Adults: ≥18 and ≤64 yrs 3. ≥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 4. 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 5. Not pregnant or lactating 6. Not a cigarette smoker or quit smoking ≥6 months ago 7. Consume \<2 alcoholic drinks daily 8. Able to use a computer or phone with internet access 9. Fluent in English 10. 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 this trial is running
Farmington, Connecticut and 2 other locations
- UConn Health — Farmington, Connecticut, United States (Not_yet_recruiting)
- Hartford HealthCare — Hartford, Connecticut, United States (Recruiting)
- University of Connecticut — Storrs, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Linda S Pescatello, PhD — Department of Kinesiology, University of Connecticut
- Study coordinator: Alexander J Wright, MS
- Email: Alexander.Wright@hhchealth.org
- Phone: (860) 486-6814
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.