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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 64 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 weeks
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Within 48 hours following each healthcare appointment, clinicians and patients will complete the validated mHealth Application Usability Questionnaire and the System Usability Scale to rate the feasibility and acceptability of P3-EX or ACSM-PAVS."
  • "Patients will be asked to perform their ExRx and monitor their exercise adherence for 12 weeks using the Timeline Followback for Exercise with virtual oversight from UConn Graduate Research Assistants."
  • "The investigators will use a one-sided Wilcoxon signed-rank test (one sample case) to assess whether the clinicians mHealth Application Usability Questionnaire ratings of P3-EX and the ACSM-PAVS are above the null hypothesis middle score of 4.0 on the Likert scale, and whether System Usability Scale ratings are above the average score of 68/100."
  • "The investigators will use a linear mixed effects model adjusting for the delivery order of P3-EX and PAVS and the time between delivery as potential covariates and interactions between these two covariates to assess differences in clinician usability questionnaire scores between P3-EX and the ACSM-PAVS."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests P3-EX, a digital tool that helps doctors make personal exercise plans for adults with risk factors for heart and blood vessel disease. It compares P3-EX with another exercise planning method over 12 weeks. Researchers will check how easy the tools are to use and whether exercise habits and health risks improve.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Doctors must work at a study site and must not already give written exercise plans or refer patients to exercise clinics or experts.
  • Doctors must be willing to recruit two patients and use both exercise planning methods.
  • Patients must be ages 18–64 and have at least one risk factor: obesity, high blood pressure, unhealthy cholesterol levels, or diabetes or prediabetes (high blood sugar).
  • Patients must not have done planned, moderate exercise for at least 30 minutes on 3 or more days a week during the past 3 months.
  • Patients must not be pregnant or breastfeeding. They must not smoke cigarettes, or must have quit at least 6 months ago.
  • Patients must drink fewer than 2 alcoholic drinks a day.
  • Patients must be fluent in English and able to use a computer or phone with internet access.
  • Patients must agree to keep their usual medicines and diet and not join other exercise or nutrition programs.

Who can't join

  • Heart or blood vessel disease, kidney disease, or other health problems that greatly limit physical activity.
  • Pain or discomfort in the chest, neck, jaw, or arms.
  • Dizziness or fainting.
  • Shortness of breath at rest, with light activity, or when lying down; or unusual tiredness or breathlessness during usual activities.
  • Swollen ankles, leg pain while walking, a racing or fluttering heartbeat, or a known heart murmur (an unusual heart sound).
  • A past stroke, past cancer, or current cancer.
  • Chronic obstructive pulmonary disease (a long-term lung disease), muscle or bone injury, or long-term back pain.
  • Depression, dementia (problems with memory and thinking), or other conditions judged to greatly limit physical activity.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (3)

CT