HypertensionP3-EXNCT07238556
A Novel Digital Tool Clinicians Can Use to Prescribe Exercise to Patients With Cardiovascular Disease Risk Factors
A study testing Experimental - 12 Week P3-EX Unsupervised Exercise Program with Virtual Weekly Oversight from Graduate Research Assistants in people with Hypertension and Dyslipidemia, run by University of Connecticut at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Hypertension, Dyslipidemia, Diabetes Mellitus
- What is being tested?
- Experimental - 12 Week P3-EX Unsupervised Exercise Program with Virtual Weekly Oversight from Graduate Research Assistants
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Mar 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Clinician Inclusion Criteria
- Practicing physicians, physician assistants, or advanced practice registered nurses employed at the study recruitment sites
- Do not recommend written exercise programs or plans to all their patients, nor refer all their patients to exercise clinics or exercise professionals
- 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
- Sedentary: have not performed planned, structured physical activity at moderate intensity for ≥30 minutes on ≥3 days per week in the last 3 months
- Adults: ≥18 and ≤64 yrs
- ≥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
- 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
- Not pregnant or lactating
- Not a cigarette smoker or quit smoking ≥6 months ago
- Consume <2 alcoholic drinks daily
- Able to use a computer or phone with internet access
- Fluent in English
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
UConn Health
Farmington, Connecticut, 06030
Peter F Robinson, MD, (860) 679-3343, perobinson@uchc.edu
- Recruiting
Hartford HealthCare
Hartford, Connecticut, 06102
Antonio B Fernandez, MD, (860) 972-1695, Antonio.Fernandez@hhchealth.org
- Recruiting
University of Connecticut
Storrs, Connecticut, 06269
Linda S Pescatello, PhD, (860) 486-0008, linda.pescatello@uconn.edu
About this study
Official title: 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
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.
Read the detailed description
Background
Approximately half of U.S. adults have 1 or more of the major CVD risk factors of obesity, hypertension, dyslipidemia, and diabetes, and 1 in 4 have 3 or more. Professional organizations such as the American College of Sports Medicine (ACSM) and the American Heart Association (AHA) recommend exercise as a first-line lifestyle therapy to prevent and treat CVD and its risk factors. The ACSM advocates clinicians to assess PA as a vital sign and prescribe exercise for every patient. However, only about 20% of U.S. adults and 44-56% of patients with CVD risk factors report being advised by their health care providers to exercise. Although clinicians are receptive to prescribing exercise to their patients, they encounter barriers to doing so such as a lack of time, training, and the tools. Digital health tools show promise as clinical decision support systems to guide clinicians in prescribing exercise to their patients. The investigators developed a clinical decision support tool named P3-EX. P3-EX includes: 1) the ACSM exercise preparticipation health screening recommendations to determine if there is a need for medical clearance; 2) an adapted AHA Life's Essential 8 cardiovascular health scoring system to determine the CVD risk factor posing the greatest risk; 3) the ACSM strategies for designing an ExRx for adults with multiple CVD risk factors; and 4) the ACSM Frequency, Intensity, Time, Type (FITT) ExRx for the prioritized CVD risk factor posing the greatest risk.
Objectives
The primary aim of this trial is to evaluate the feasibility and acceptability of P3-EX for clinicians to use to prescribe exercise to patients with CVD risk factors.
The secondary aim is to explore the preliminary efficacy of P3-EX to improve patient CVD risk factors, PA levels, and exercise adherence.
Study Procedures
The investigators will recruit 24 clinicians, including physicians, physician assistants, or advanced practice registered nurses, from Hartford HealthCare or UConn Health clinics using email listservs, newsletters, university communication channels, flyers, and word of mouth. Clinicians will attend a virtual study orientation led by a UConn Graduate Research Assistant to provide informed consent, confirm eligibility, complete demographics, assess barriers to and confidence with ExRx, and receive brief ExRx delivery training to their patients. Clinicians will then recruit two of their patients (N=48) who have obesity, hypertension, dyslipidemia, and/or diabetes. Patients will attend two in-person study visits led by a UConn Graduate Research Assistant at a clinic in Hartford or Farmington, CT, to provide informed consent, confirm eligibility, complete demographics, and assess the AHA Life's Essential 8, anthropometrics, vitals, subjective PA levels via the Timeline Followback for Exercise, and objective PA levels via accelerometry. Patients will attend their local Quest Diagnostics Service Center to assess blood lipid-lipoproteins and blood glucose. Clinicians will be individually randomized with a 1:1 allocation ratio to deliver an P3-EX ExRx to one of their patients and the ACSM-PAVS ExRx to the other patient in a random sequence crossover design. Patients will attend their healthcare appointment with their clinicians and receive either a P3-EX ExRx (n=24) or the ACSM-PAVS ExRx (n=24). 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. Patients will receive a 12-week exercise program information packet, two exercise guidance virtual student visits led by UConn Graduate Research Assistants, and weekly progressive FITT exercise goals via email from UConn Graduate Research Assistants. UConn Graduate Research will also provide Timeline Followback for Exercise summary reports to patients weekly via email. At post-intervention, patients will attend two more in-person study visits led by a UConn Graduate Research Assistant at a clinic in Hartford or Farmington, CT to assess trial satisfaction, AHA Life's Essential 8, CVD risk factors and PA levels.
Statistical Analysis Plan
The investigators will conduct statistical analyses using Statistical Package for the Social Sciences Version 30. The investigators will first use descriptive statistics and graphical techniques to ensure all test assumptions are met, including the inspection for outliers, normal distributions, and homogeneity of variances. Missing values will be addressed using model-based approaches and/or multiple imputations when appropriate to include the entire randomized sample. If normality assumptions are not met for secondary outcomes, considerations will be made to transform the data to achieve a normal distribution or use alternative non-parametric approaches such as permutated tests. An alpha level of 0.05 will be used to determine statistical significance.
The investigators will use the following statistical approaches to evaluate the feasibility and acceptability of P3-EX for clinicians to use to prescribe exercise to patients with CVD risk factors. 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. The investigators will use normal linear regression to test the strength of relationships between the three domains on the mHealth Application Usability Questionnaire and the usage time of P3-EX.
The investigators will use the following statistical approaches to explore the preliminary efficacy of P3-EX to improve patient PA levels, CVD risk factors, and exercise adherence. A one-way Analysis of Variance will test if pre-intervention values are equal between groups, indicating if there is a need to adjust for potential covariates related to demographics, medication use, and/or pre-intervention PA level and CVD risk factor values. The investigators will use a repeated measures two-way Analysis of Covariance using a linear mixed effects model to test patient differences in PA level and CVD risk factor changes over 12 weeks between the P3-EX and the ACSM-PAVS groups, adjusting for potential covariates related to demographics, medication use, and/or pre-intervention values.
Scientific Rationale
The novelty of P3-EX is supported by the investigators' systematic review which evaluated whether there are decision support tools on the market that utilize evidence-based ExRx standards of the ACSM and AHA to target CVD risk factors. The investigators evaluated 219 exercise apps that were rated ≥4 out of 5 overall with ≥1000 reviews, free to download, and not gender specific. Of the 219 apps, very few (0 to 4.3%) were evidence based, had a preparticipation screening protocol, framed exercise plans by the FITT of ExRx, specified special considerations, or focused on chronic diseases or health conditions, and only 28% built CVD risk factor profiles. The investigators concluded there are no evidence-based ExRx apps on the market like P3-EX.
The potential usability and user satisfaction of P3-EX in the healthcare setting is further supported by the investigators' feasibility survey study. A total of 309 healthcare providers and allied health professionals, including 101 physicians, completed a timed case study using the P3-EX web-based algorithm, and then rated its satisfaction and usability using the Mobile Application Rating Scale. Most of the respondents (93%) agreed they would recommend P3-EX to their colleagues, the primary goal of any feasibility study, and 80% agreed P3-EX produced safe ExRx and were satisfied with P3-EX. Also, over 70% agreed P3-EX would make their patients healthier and could save them time, prescribing exercise in an average time of 4.6 minutes.
Conclusions
This protocol provides the scientific rationale and methodology to test P3-EX within a real-world clinical setting, to inform the feasibility of using P3-EX as a digital health support tool to be used by clinicians to prescribe personalized FITT ExRx to their patients with CVD risk factors, and the preliminary efficacy of P3-EX to improve patient cardiovascular health and PA levels. If successful, this trial could demonstrate that P3-EX is a solution for clinicians to overcome their barriers to ExRx, which includes lacking the tools, training, time, and confidence. The investigators intend to use the pilot data for secondary outcomes to power a larger clinical trial to evaluate the efficacy of P3-EX for improving PA levels and CVD risk factors.
- Conditions
- Hypertension, Dyslipidemia, Diabetes Mellitus, Obesity, Cardiovascular Disease
- Being tested
- Experimental - 12 Week P3-EX Unsupervised Exercise Program with Virtual Weekly Oversight from Graduate Research Assistants, Active Control - 12 Week ACSM-PAVS Unsupervised Exercise Program with Virtual Weekly Oversight from Graduate Research Assistants
- Keywords
- Exercise prescription, Exercise Therapy, Physical Activity, Preventive Health Services, Health Behavior, Medical Informatics Applications, Health technology, Precision Medicine, Primary Health Care
- Medical subject headings
- Hypertension, Dyslipidemias, Diabetes Mellitus, Obesity, Cardiovascular Diseases, Motor Activity, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental - 12 Week P3-EX Unsupervised Exercise Program with Virtual Weekly Oversight from Graduate Research AssistantsBehavioural
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 AssistantsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Prioritizes Personalizes Prescribes EXercise (P3-EX) | Experimental | Clinicians will use Prioritizes Personalizes Prescribes Exercise (P3-EX), hosted by a web-based platform, to deliver P3-EX, an evidence-based personalized exercise prescription to improve cardiovascular disease (CVD) risk factors.
P3-EX will determine whether the patient needs medical clearance. P3-EX will score the patient's CVD risk factors using an adapted American Heart Association Life's Essential 8 cardiovascular health scoring system to determine the CVD risk factor posing the greatest risk. If ≥2 CVD risk factors are tied for the greatest risk, P3-EX will prompt the clinician to choose an American College of Sports Medicine strategy to prioritize one CVD risk factor to personalize the Frequency, Intensity, Time, and Type (FITT) exercise prescription. P3-EX will also produce special exercise considerations for the prioritized CVD risk factor. The clinician will print the exercise prescription and give it to the patient to perform for 12 weeks. Receives: Behavioral: Experimental - 12 Week P3-EX Unsupervised Exercise Program with Virtual Weekly Oversight from Graduate Research Assistants |
| American College of Sports Medicine Physical Activity Vital Sign (ACSM-PAVS) | Active comparator | Clinicians will use a hard copy instruction manual adapted from the Exercise is Medicine HealthCare Providers' Action Guide to deliver the American College of Sports Medicine Physical Activity Vital Sign (ACSM-PAVS), a generic exercise program to improve general health.
The clinicians will ask the patient exercise preparticipation health screening questions to determine whether medical clearance is needed. The clinicians will assess their patient's physical activity levels as a vital sign (i.e., minutes per week of moderate to vigorous intensity exercise and days per week of resistance exercise). The clinician will give the patient the ACSM-PAVS exercise program as a handout, which recommends the Physical Activity Guidelines for Americans of 150 minutes per week of moderate and/or 75 minutes per week of vigorous intensity aerobic exercise (or a combination) and 2 days per week of muscular strengthening exercise. Receives: Behavioral: Active Control - 12 Week ACSM-PAVS Unsupervised Exercise Program with Virtual Weekly Oversight from Graduate Research Assistants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and Acceptability of Prioritize Personalize Prescribe EXercise (P3-EX)
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. Clinicians 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.
Measured: Within 48 hours following the delivery of P3-EX and ACSM-PAVS
Feasibility and Acceptability of Prioritize Personalize Prescribe EXercise (P3-EX)
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. Clinicians 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.
Measured: Within 48 hours following the delivery of P3-EX and ACSM-PAVS
Secondary outcomes (15)
Clinician Barriers to and Confidence with Exercise Prescription (ExRx)
Clinicians will complete an adapted ExRx self-reflection questionnaire before completing brief ExRx training and within 48 hours following the delivery of either Prioritize Personalize Prescribe EXercise (P3-EX) or the American College of Sports Medicine Physical Activity Vital Sign (ACSM-PAVS), to assess the impact of the trial on their perceived barriers to and confidence with ExRx. Responses will be rated a Likert scale from 1 to 4, with 4 being the highest impact from a barrier or the highest confidence with a skill (mean ± SD).
Measured: Before completing brief ExRx training and within 48 hours following the delivery of either P3-EX or ACSM-PAVS
American Heart Association Life's Essential 8 Score Change from Baseline
Patient Cardiovascular Health Scores from 0 to 100 points will be determined at pre- and 12-weeks post-intervention (mean ± SD) based on patient survey responses to metrics of diet, PA, nicotine exposure, sleep health, and assessed values of body mass index, blood pressure, blood lipids, and blood glucose.
Measured: 12 weeks
Resting Blood Pressure Changes
Patient resting systolic and diastolic blood pressure (mm Hg) will be assessed at pre- and 12-weeks post-intervention (mean ± SD) via automatic monitors (OMRON HEM-705CP, Kyoto, Japan), to indicate health improvement for hypertension.
Measured: 12 weeks
Resting Heart Rate Changes
Resting heart rate (bpm) will be assessed at pre- and 12-weeks post-intervention (mean ± SD) via automatic monitors (Polar Electro Oy F7, Kempele, Finland, respectively), to indicate health improvement for cardiovascular fitness.
Measured: 12 weeks
Body Mass Index Changes
Height (m) and weight (kg) will be assessed at pre- and 12-weeks post-intervention (mean ± SD) via a mechanical beam balance scale with stadiometer (Health o meter, Pelion, IL, USA) to calculate body mass index (kg/m2) and indicate health improvement for obesity.
Measured: 12 weeks
Waist Circumference Changes
Patient waist circumference (cm) will be assessed at pre- and 12-weeks post-intervention (mean ± SD) via a Gullick tape measure (Sammons Preston) to indicate health improvement for obesity.
Measured: 12 weeks
Blood Lipid-Lipoproteins Profile Changes
Patient total cholesterol, triglycerides, high-density lipoproteins, and low-density lipoproteins (mg/dL) will be assessed at pre- and 12 weeks post-intervention (mean ± SD), processed by phlebotomy technicians at Quest Patient Service Centers, to indicate health improvement for dyslipidemia.
Measured: 12 weeks
Blood Glucose Profile Changes
Glycated hemoglobin (%) will be assessed at pre- and 12 weeks post-intervention (mean ± SD), processed by phlebotomy technicians at Quest Patient Service Centers, to indicate health improvement for diabetes.
Measured: 12 weeks
Blood Glucose Profile Changes
Fasting plasma glucose (mg/dL) will be assessed at pre- and 12 weeks post-intervention (mean ± SD), processed by phlebotomy technicians at Quest Patient Service Centers, to indicate health improvement for diabetes.
Measured: 12 weeks
Subjective Physical Activity Levels Changes
Patient self-reported physical activity levels will be assessed at pre-intervention and 12 weeks post-intervention via the Timeline Followback for Exercise for the various Frequency, Intensity, Time, and Type (FITT) metrics (mean ± SD). The Timeline Followback for Exercise is a validated calendar diary method for recording the FITT of exercise, whereby, frequency is the number of days per week that physical activity is performed; type is the modality of physical activity performed (e.g., running, weightlifting); time is the duration performed in minutes for each modality; and intensity using the Borg 6-20 rating of perceived exertion scale. Graduate Research Assistants will assign a metabolic equivalent (MET) value for each recorded exercise to calculate exercise volume in MET*min/wk.
Measured: Weekly for 12 weeks
Exercise Adherence
Patient self-reported physical activity levels will be assessed weekly for the 12-week exercise intervention via the Timeline Followback for Exercise for the various Frequency, Intensity, Time, and Type (FITT) metrics (mean ± SD). The Timeline Followback for Exercise is a validated calendar diary method for recording the FITT of exercise, whereby, frequency is the number of days per week that physical activity is performed; type is the modality of physical activity performed (e.g., running, weightlifting); time is the duration performed in minutes for each modality; and intensity using the Borg 6-20 rating of perceived exertion scale. Graduate Research Assistants will assign a metabolic equivalent (MET) value for each recorded exercise to calculate exercise volume in MET*min/wk.
Measured: Weekly for 12 weeks
Objective Physical Activity Level Changes
Minutes of physical activity per day within different intensities (i.e., light, moderate, and vigorous) will be measured at pre- and 12-weeks post-intervention (mean ± SD) via accelerometers (Actigraph wGT3X-BT, Pensacola, FL).
Measured: 12 weeks
Energy Expenditure Changes
Patient energy expenditure (kcal) will be measured at pre- and 12-weeks post-intervention (mean ± SD) via accelerometers (Actigraph wGT3X-BT, Pensacola, FL).
Measured: 12 weeks
Step Count Changes
Steps per day will be measured at pre- and 12-weeks post-intervention (mean ± SD) via accelerometers (Actigraph wGT3X-BT, Pensacola, FL).
Measured: 12 weeks
Sedentary Behavior Changes
Sedentary time (minutes/wk) will be measured at pre- and 12-weeks post-intervention (mean ± SD) via accelerometers (Actigraph wGT3X-BT, Pensacola, FL).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start30 Mar 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Clinicians (N=24) will deliver a Prioritized Personalized EXercise Prescription (P3-EX) to one of their patients with cardiovascular disease risk factors (n=24) and the American College of Sports Medicine Physical Activity Vital Sign exercise program to the other with cardiovascular disease risk factors (n=24) in random sequence.
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Collaborators
- Hartford HealthCare, UConn Health
- Responsible party
- Principal investigator, Linda Pescatello, University of Connecticut
- Investigators
- Linda S Pescatello, PhD, Principal investigator, Department of Kinesiology, University of ConnecticutAntonio B Fernandez, MD, Principal investigator, Hartford HealthCare Heart & Vascular Institute, Hartford HospitalGregory Panza, PhD, Study director, Department of Research Administration, Hartford HealthCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07238556
- Sponsor's protocol ID
- E25-0518
- Other IDs
- N/A (Internal Funding), N/A (Internal Funding), E-HHC-2025-0198
- Acronym
- P3-EX
- Status last verified
- Oct 2026
- First submitted
- 7 Nov 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The analyzable dataset for de-identified individual participant data (IPD) will be made available upon request and provided as supplementary material with any published manuscripts.
Publications
Zaleski AL, Berkowsky R, Craig KJT, Pescatello LS. Comprehensiveness, Accuracy, and Readability of Exercise Recommendations Provided by an AI-Based Chatbot: Mixed Methods Study. JMIR Med Educ. 2024 Jan 11;10:e51308. doi: 10.2196/51308.
PubMed 38206661Chen S, Wu Y, Kennedy J, Panza G, Guidry MZ, Pescatello LS; FACSM. An exercise prescription algorithm for clinicians to use with their patients with cardiovascular disease risk factors. Digit Health. 2025 Jul 16;11:20552076251360884. doi: 10.1177/20552076251360884. eCollection 2025 Jan-Dec.
PubMed 40677518Chen S, Wu Y, Bushey EL, Pescatello LS. Evaluation of Exercise Mobile Applications for Adults with Cardiovascular Disease Risk Factors. J Cardiovasc Dev Dis. 2023 Nov 28;10(12):477. doi: 10.3390/jcdd10120477.
PubMed 38132645Pescatello LS, Wu Y, Panza GA, Zaleski A, Guidry M. Development of a Novel Clinical Decision Support System for Exercise Prescription Among Patients With Multiple Cardiovascular Disease Risk Factors. Mayo Clin Proc Innov Qual Outcomes. 2020 Oct 22;5(1):193-203. doi: 10.1016/j.mayocpiqo.2020.08.005. eCollection 2021 Feb.
PubMed 33718793Wright AJ, Panza GA, Fernandez AB, Robinson PF, DeScenza VR, Chen MH, Lee EC, Guidry MA, Pescatello LS. 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. Healthcare (Basel). 2026 Jan 12;14(2):188. doi: 10.3390/healthcare14020188.
PubMed 41595324
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07238556
- Acronym / sponsor ID
- P3-EX / E25-0518
- Conditions
- Hypertension, Dyslipidemia, Diabetes Mellitus, Obesity, Cardiovascular Disease
- Keywords
- Exercise prescription, Exercise Therapy, Physical Activity, Preventive Health Services, Health Behavior, Medical Informatics Applications, Health technology, Precision Medicine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Collaborators
- Hartford HealthCare, UConn Health
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background
Approximately half of U.S. adults have 1 or more of the major CVD risk factors of obesity, hypertension, dyslipidemia, and diabetes, and 1 in 4 have 3 or more. Professional organizations such as the American College of Sports Medicine (ACSM) and the American Heart Association (AHA) recommend exercise as a first-line lifestyle therapy to prevent and treat CVD and its risk factors. The ACSM advocates clinicians to assess PA as a vital sign and prescribe exercise for every patient. However, only about 20% of U.S. adults and 44-56% of patients with CVD risk factors report being advised by their health care providers to exercise. Although clinicians are receptive to prescribing exercise to their patients, they encounter barriers to doing so such as a lack of time, training, and the tools. Digital health tools show promise as clinical decision support systems to guide clinicians in prescribing exercise to their patients. The investigators developed a clinical decision support tool named P3-EX. P3-EX includes: 1) the ACSM exercise preparticipation health screening recommendations to determine if there is a need for medical clearance; 2) an adapted AHA Life's Essential 8 cardiovascular health scoring system to determine the CVD risk factor posing the greatest risk; 3) the ACSM strategies for designing an ExRx for adults with multiple CVD risk factors; and 4) the ACSM Frequency, Intensity, Time, Type (FITT) ExRx for the prioritized CVD risk factor posing the greatest risk.
Objectives
The primary aim of this trial is to evaluate the feasibility and acceptability of P3-EX for clinicians to use to prescribe exercise to patients with CVD risk factors.
The secondary aim is to explore the preliminary efficacy of P3-EX to improve patient CVD risk factors, PA levels, and exercise adherence.
Study Procedures
The investigators will recruit 24 clinicians, including physicians, physician assistants, or advanced practice registered nurses, from Hartford HealthCare or UConn Health clinics using email listservs, newsletters, university communication channels, flyers, and word of mouth. Clinicians will attend a virtual study orientation led by a UConn Graduate Research Assistant to provide informed consent, confirm eligibility, complete demographics, assess barriers to and confidence with ExRx, and receive brief ExRx delivery training to their patients. Clinicians will then recruit two of their patients (N=48) who have obesity, hypertension, dyslipidemia, and/or diabetes. Patients will attend two in-person study visits led by a UConn Graduate Research Assistant at a clinic in Hartford or Farmington, CT, to provide informed consent, confirm eligibility, complete demographics, and assess the AHA Life's Essential 8, anthropometrics, vitals, subjective PA levels via the Timeline Followback for Exercise, and objective PA levels via accelerometry. Patients will attend their local Quest Diagnostics Service Center to assess blood lipid-lipoproteins and blood glucose. Clinicians will be individually randomized with a 1:1 allocation ratio to deliver an P3-EX ExRx to one of their patients and the ACSM-PAVS ExRx to the other patient in a random sequence crossover design. Patients will attend their healthcare appointment with their clinicians and receive either a P3-EX ExRx (n=24) or the ACSM-PAVS ExRx (n=24). 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. Patients will receive a 12-week exercise program information packet, two exercise guidance virtual student visits led by UConn Graduate Research Assistants, and weekly progressive FITT exercise goals via email from UConn Graduate Research Assistants. UConn Graduate Research will also provide Timeline Followback for Exercise summary reports to patients weekly via email. At post-intervention, patients will attend two more in-person study visits led by a UConn Graduate Research Assistant at a clinic in Hartford or Farmington, CT to assess trial satisfaction, AHA Life's Essential 8, CVD risk factors and PA levels.
Statistical Analysis Plan
The investigators will conduct statistical analyses using Statistical Package for the Social Sciences Version 30. The investigators will first use descriptive statistics and graphical techniques to ensure all test assumptions are met, including the inspection for outliers, normal distributions, and homogeneity of variances. Missing values will be addressed using model-based approaches and/or multiple imputations when appropriate to include the entire randomized sample. If normality assumptions are not met for secondary outcomes, considerations will be made to transform the data to achieve a normal distribution or use alternative non-parametric approaches such as permutated tests. An alpha level of 0.05 will be used to determine statistical significance.
The investigators will use the following statistical approaches to evaluate the feasibility and acceptability of P3-EX for clinicians to use to prescribe exercise to patients with CVD risk factors. 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. The investigators will use normal linear regression to test the strength of relationships between the three domains on the mHealth Application Usability Questionnaire and the usage time of P3-EX.
The investigators will use the following statistical approaches to explore the preliminary efficacy of P3-EX to improve patient PA levels, CVD risk factors, and exercise adherence. A one-way Analysis of Variance will test if pre-intervention values are equal between groups, indicating if there is a need to adjust for potential covariates related to demographics, medication use, and/or pre-intervention PA level and CVD risk factor values. The investigators will use a repeated measures two-way Analysis of Covariance using a linear mixed effects model to test patient differences in PA level and CVD risk factor changes over 12 weeks between the P3-EX and the ACSM-PAVS groups, adjusting for potential covariates related to demographics, medication use, and/or pre-intervention values.
Scientific Rationale
The novelty of P3-EX is supported by the investigators' systematic review which evaluated whether there are decision support tools on the market that utilize evidence-based ExRx standards of the ACSM and AHA to target CVD risk factors. The investigators evaluated 219 exercise apps that were rated ≥4 out of 5 overall with ≥1000 reviews, free to download, and not gender specific. Of the 219 apps, very few (0 to 4.3%) were evidence based, had a preparticipation screening protocol, framed exercise plans by the FITT of ExRx, specified special considerations, or focused on chronic diseases or health conditions, and only 28% built CVD risk factor profiles. The investigators concluded there are no evidence-based ExRx apps on the market like P3-EX.
The potential usability and user satisfaction of P3-EX in the healthcare setting is further supported by the investigators' feasibility survey study. A total of 309 healthcare providers and allied health professionals, including 101 physicians, completed a timed case study using the P3-EX web-based algorithm, and then rated its satisfaction and usability using the Mobile Application Rating Scale. Most of the respondents (93%) agreed they would recommend P3-EX to their colleagues, the primary goal of any feasibility study, and 80% agreed P3-EX produced safe ExRx and were satisfied with P3-EX. Also, over 70% agreed P3-EX would make their patients healthier and could save them time, prescribing exercise in an average time of 4.6 minutes.
Conclusions
This protocol provides the scientific rationale and methodology to test P3-EX within a real-world clinical setting, to inform the feasibility of using P3-EX as a digital health support tool to be used by clinicians to prescribe personalized FITT ExRx to their patients with CVD risk factors, and the preliminary efficacy of P3-EX to improve patient cardiovascular health and PA levels. If successful, this trial could demonstrate that P3-EX is a solution for clinicians to overcome their barriers to ExRx, which includes lacking the tools, training, time, and confidence. The investigators intend to use the pilot data for secondary outcomes to power a larger clinical trial to evaluate the efficacy of P3-EX for improving PA levels and CVD risk factors.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Clinicians (N=24) will deliver a Prioritized Personalized EXercise Prescription (P3-EX) to one of their patients with cardiovascular disease risk factors (n=24) and the American College of Sports Medicine Physical Activity Vital Sign exercise program to the other with cardiovascular disease risk factors (n=24) in random sequence.
| Arm | Type | Receives |
|---|---|---|
| Prioritizes Personalizes Prescribes EXercise (P3-EX) | Experimental | Behavioral: Experimental - 12 Week P3-EX Unsupervised Exercise Program with Virtual Weekly Oversight from Graduate Research AssistantsClinicians will use Prioritizes Personalizes Prescribes Exercise (P3-EX), hosted by a web-based platform, to deliver P3-EX, an evidence-based personalized exercise prescription to improve cardiovascular disease (CVD) risk factors. P3-EX will determine whether the patient needs medical clearance. P3-EX will score the patient's CVD risk factors using an adapted American Heart Association Life's Essential 8 cardiovascular health scoring system to determine the CVD risk factor posing the greatest risk. If ≥2 CVD risk factors are tied for the greatest risk, P3-EX will prompt the clinician to choose an American College of Sports Medicine strategy to prioritize one CVD risk factor to personalize the Frequency, Intensity, Time, and Type (FITT) exercise prescription. P3-EX will also produce special exercise considerations for the prioritized CVD risk factor. The clinician will print the exercise prescription and give it to the patient to perform for 12 weeks. |
| American College of Sports Medicine Physical Activity Vital Sign (ACSM-PAVS) | Active comparator | Behavioral: Active Control - 12 Week ACSM-PAVS Unsupervised Exercise Program with Virtual Weekly Oversight from Graduate Research AssistantsClinicians will use a hard copy instruction manual adapted from the Exercise is Medicine HealthCare Providers' Action Guide to deliver the American College of Sports Medicine Physical Activity Vital Sign (ACSM-PAVS), a generic exercise program to improve general health. The clinicians will ask the patient exercise preparticipation health screening questions to determine whether medical clearance is needed. The clinicians will assess their patient's physical activity levels as a vital sign (i.e., minutes per week of moderate to vigorous intensity exercise and days per week of resistance exercise). The clinician will give the patient the ACSM-PAVS exercise program as a handout, which recommends the Physical Activity Guidelines for Americans of 150 minutes per week of moderate and/or 75 minutes per week of vigorous intensity aerobic exercise (or a combination) and 2 days per week of muscular strengthening exercise. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental - 12 Week P3-EX Unsupervised Exercise Program with Virtual Weekly Oversight from Graduate Research AssistantsUConn 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. | Behavioural | Prioritizes Personalizes Prescribes EXercise (P3-EX) |
| Active Control - 12 Week ACSM-PAVS Unsupervised Exercise Program with Virtual Weekly Oversight from Graduate Research AssistantsUniversity 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. | Behavioural | American College of Sports Medicine Physical Activity Vital Sign (ACSM-PAVS) |
Primary outcome
Feasibility and Acceptability of Prioritize Personalize Prescribe EXercise (P3-EX)
Time frame: 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. Clinicians 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)
Time frame: 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. Clinicians 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.
15 secondary outcomes
Clinician Barriers to and Confidence with Exercise Prescription (ExRx)
Time frame: Before completing brief ExRx training and within 48 hours following the delivery of either P3-EX or ACSM-PAVS
American Heart Association Life's Essential 8 Score Change from Baseline
Time frame: 12 weeks
Resting Blood Pressure Changes
Time frame: 12 weeks
Resting Heart Rate Changes
Time frame: 12 weeks
Body Mass Index Changes
Time frame: 12 weeks
Waist Circumference Changes
Time frame: 12 weeks
Blood Lipid-Lipoproteins Profile Changes
Time frame: 12 weeks
Blood Glucose Profile Changes
Time frame: 12 weeks
Blood Glucose Profile Changes
Time frame: 12 weeks
Subjective Physical Activity Levels Changes
Time frame: Weekly for 12 weeks
Exercise Adherence
Time frame: Weekly for 12 weeks
Objective Physical Activity Level Changes
Time frame: 12 weeks
Energy Expenditure Changes
Time frame: 12 weeks
Step Count Changes
Time frame: 12 weeks
Sedentary Behavior Changes
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Background: PubMed 38206661Zaleski AL, Berkowsky R, Craig KJT, Pescatello LS. Comprehensiveness, Accuracy, and Readability of Exercise Recommendations Provided by an AI-Based Chatbot: Mixed Methods Study. JMIR Med Educ. 2024 Jan 11;10:e51308. doi: 10.2196/51308.
- Background: PubMed 40677518Chen S, Wu Y, Kennedy J, Panza G, Guidry MZ, Pescatello LS; FACSM. An exercise prescription algorithm for clinicians to use with their patients with cardiovascular disease risk factors. Digit Health. 2025 Jul 16;11:20552076251360884. doi: 10.1177/20552076251360884. eCollection 2025 Jan-Dec.
- Background: PubMed 38132645Chen S, Wu Y, Bushey EL, Pescatello LS. Evaluation of Exercise Mobile Applications for Adults with Cardiovascular Disease Risk Factors. J Cardiovasc Dev Dis. 2023 Nov 28;10(12):477. doi: 10.3390/jcdd10120477.
- Background: PubMed 33718793Pescatello LS, Wu Y, Panza GA, Zaleski A, Guidry M. Development of a Novel Clinical Decision Support System for Exercise Prescription Among Patients With Multiple Cardiovascular Disease Risk Factors. Mayo Clin Proc Innov Qual Outcomes. 2020 Oct 22;5(1):193-203. doi: 10.1016/j.mayocpiqo.2020.08.005. eCollection 2021 Feb.
- Derived from this study: PubMed 41595324Wright AJ, Panza GA, Fernandez AB, Robinson PF, DeScenza VR, Chen MH, Lee EC, Guidry MA, Pescatello LS. 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. Healthcare (Basel). 2026 Jan 12;14(2):188. doi: 10.3390/healthcare14020188.
- Individual participant dataSharing planned: Yes. The analyzable dataset for de-identified individual participant data (IPD) will be made available upon request and provided as supplementary material with any published manuscripts.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Linda S Pescatello, PhD principal investigator
Department of Kinesiology, University of Connecticut
Antonio B Fernandez, MD principal investigator
Hartford HealthCare Heart & Vascular Institute, Hartford Hospital
Gregory Panza, PhD study director
Department of Research Administration, Hartford HealthCare
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental - 12 Week P3-EX Unsupervised Exercise Program with Virtual Weekly Oversight from Graduate Research Assistants in people with Hypertension and Dyslipidemia, run by University of Connecticut at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander J Wright, MS ((860) 486-6814, Alexander.Wright@hhchealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and Acceptability of Prioritize Personalize Prescribe EXercise (P3-EX) (time frame: Within 48 hours following the delivery of P3-EX and ACSM-PAVS). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07238556, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.