NCT07238556 A Novel Digital Tool Clinicians Can Use to Prescribe Exercise to Patients With Cardiovascular Disease Risk Factors
| NCT ID | NCT07238556 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Connecticut |
| Condition | Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2026-03-30 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 72 participants in total. It began in 2026-03-30 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Linda S Pescatello, PhD
PRINCIPAL INVESTIGATOR
Department of Kinesiology, University of Connecticut
Frequently Asked Questions
Who can join the NCT07238556 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 64 Years, studying Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07238556 currently recruiting?
Yes, NCT07238556 is actively recruiting participants. Contact the research team at Alexander.Wright@hhchealth.org for enrollment information.
Where is the NCT07238556 trial being conducted?
This trial is being conducted at Farmington, United States, Hartford, United States, Storrs, United States.
Who is sponsoring the NCT07238556 clinical trial?
NCT07238556 is sponsored by University of Connecticut. The principal investigator is Linda S Pescatello, PhD at Department of Kinesiology, University of Connecticut. The trial plans to enroll 72 participants.