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Hypertension / Active Control - 12 Week ACSM-PAVS Unsupervised Exercise Program with Virtual We / Diabetes Mellitus · Interventional Study
ClinicalTrials.gov · August 12, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registry record for a feasibility and pilot efficacy RCT of a digital exercise prescription tool (P3-EX) for patients with cardiovascular disease risk factors. The primary outcomes are feasibility and acceptability assessed by validated questionnaires; secondary exploratory endpoints include CVD risk factors and exercise adherence. No results are yet reported in this registry record.
Interventional, Randomized, Crossover, Open label, Health Services Research purpose. Hypertension, Dyslipidemia, Diabetes Mellitus, Obesity, Cardiovascular Disease; age from 18 Years; to 64 Years. Intervention: Prioritizes Personalizes Prescribes EXercise (P3-EX). Compared with: American College of Sports Medicine Physical Activity Vital… — Active Comparator. n = 72. 3 sites: United States.
This is a registry record for a feasibility and pilot efficacy RCT of a digital exercise prescription tool (P3-EX) for patients with cardiovascular disease risk factors. The primary outcomes are feasibility and acceptability assessed by validated questionnaires; secondary exploratory endpoints include CVD risk factors and exercise adherence. No results are yet reported in this registry record.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
Feasibility and pilot efficacy study of a novel digital tool in a small sample with primary focus on usability and acceptability rather than clinical efficacy; results not yet reported.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07238556). This is a study registration, not published results. Lead sponsor: University of Connecticut. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 72 participants (ESTIMATED). Conditions: Hypertension, Dyslipidemia, Diabetes Mellitus, Obesity, Cardiovascular Disease. Interventions: BEHAVIORAL: Experimental - 12 Week P3-EX Unsupervised Exercise Program with Virtual Weekly Oversight from Graduate Research Assistants; BEHAVIORAL: Active Control - 12 Week ACSM-PAVS Unsupervised Exercise Program with Virtual Weekly Oversight from Graduate Research Assistants. Primary outcome measures: Feasibility and Acceptability of Prioritize Personalize Prescribe EXercise (P3-EX) , Within 48 hours following the delivery of P3-EX and ACSM-PAVS; Feasibility and Acceptability of Prioritize Personalize Prescribe EXercise (P3-EX) , Within 48 hours following the delivery of P3-EX and ACSM-PAVS. 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 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.
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