Clinical trial

A Novel Digital Tool Physicians Can Use to Prescribe Exercise to Patients With Cardiovascular Disease Risk Factors

Recruiting now · Not applicable · 1 countries · Registry ID NCT07238556

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 64 Years
SexAll
Healthy volunteersNot accepted
ConditionHypertension, Dyslipidemia, Diabetes Mellitus, Obesity, Cardiovascular Disease

Full registry 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.

Treatments and study arms

Experimental - 12 Week P3-EX Unsupervised Exercise Program with Virtual Weekly Oversight from Graduate Research Assistants

Behavioral

UConn Graduate Research Assistants will provide patients with virtual weekly oversight to follow their P3-EX unsupervised exercise program for 12 weeks. Patients will choose the location and the FITT of exercise they prefer. UConn Graduate Research Assistants will provide all patients with a 12-week exercise program information packet containing progressive FITT exercise recommendations for their exercise program. Patients will use an exercise diary called the Timeline Followback for Exercise to record the FITT of exercise daily. Patients will attend two virtual study visits led by UConn Graduate Research Assistants during the first week and midway through the intervention to receive standardized guidance on how they are doing following their exercise program. UConn Graduate Research Assistants will email all patients weekly to provide their progressive FITT exercise recommendations and summary reports of their Timeline Followback for Exercise recordings.

Active Control - 12 Week ACSM-PAVS Unsupervised Exercise Program with Virtual Weekly Oversight from Graduate Research Assistants

Behavioral

University of Connecticut (UConn) Graduate Research Assistants will provide patients with virtual weekly oversight to follow their ACSM-PAVS unsupervised exercise program for 12 weeks. Patients will choose the location and the FITT of exercise they prefer. UConn Graduate Research Assistants will provide all patients with a 12-week exercise program information packet containing progressive FITT exercise recommendations for their exercise program. Patients will use an exercise diary called the Timeline Followback for Exercise to record the FITT of exercise daily. Patients will attend two virtual study visits led by UConn Graduate Research Assistants during the first week and midway through the intervention to receive standardized guidance. UConn Graduate Research Assistants will email all patients weekly to provide their progressive FITT exercise recommendations and summary reports of their Timeline Followback for Exercise recordings.

Primary outcomes

Feasibility and Acceptability of Prioritize Personalize Prescribe EXercise (P3-EX)Within 48 hours following the delivery of P3-EX and ACSM-PAVS

The mHealth Application Usability Questionnaire is validated to measure the usability of mobile health apps for healthcare providers and/or patients through 21 items spilt into three subscales; Ease of Use and Satisfaction, System Information Arrangement, and Usefulness. The rating of each item is scaled from 1 to 7, and responses are averaged to provide a single score. Physicians will rate both P3-EX and American College of Sports Medicine Physical Activity Vital Sign (ACSM-PAVS), and patients will rate the one they receive. Overall scores (mean ± SD) will be compared to the middle score of 4.0.

Feasibility and Acceptability of Prioritize Personalize Prescribe EXercise (P3-EX)Within 48 hours following the delivery of P3-EX and ACSM-PAVS

The System Usability Scale is the most common questionnaire to assess the usability of mHealth apps. Ratings for each of the 10 items are scaled from 1 to 5. Physicians will rate both P3-EX and American College of Sports Medicine Physical Activity Vital Sign (ACSM-PAVS), and patients will rate the one they receive. Overall scores (mean ± SD) will be scaled from 0 to 100 and compared to normative reference ratings and scores in the literature.

Study locations

3 locations were listed when this page was built. The first 40 are shown.

UConn Health🇺🇸 Farmington, Connecticut, United States
Peter F Robinson, MDContact
Hartford HealthCare🇺🇸 Hartford, Connecticut, United States
Antonio B Fernandez, MDContact
University of Connecticut🇺🇸 Storrs, Connecticut, United States
Linda S Pescatello, PhDContact