Digital tool for doctors to prescribe exercise for people with cardiovascular risk factors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Clinician Inclusion Criteria

1. Practicing physicians, physician assistants, or advanced practice registered nurses employed at the study recruitment sites
2. Do not recommend written exercise programs or plans to all their patients, nor refer all their patients 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 it's running

• Hartford HealthCare
  Hartford, Connecticut, United States Recruiting
• University of Connecticut
  Storrs, Connecticut, United States Recruiting
• UConn Health
  Farmington, Connecticut, United States Not yet 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.