A Pilot Feasibility and Acceptability Study of Remote ExerciSe Training mOdalities (PRESTO
This study will investigate the acceptability and efficacy of 12 weeks of: Smart-device app-based (MyZone) Asynchronous Virtual, Synchronous Virtual, and in-person aerobic training in individuals at risk for Cardiovascular Disease (CVD) who do are not meeting American Heart Association (AHA) guidelines for physical act
| Condition(s) | Cardiovascular Diseases |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | This study will investigate the acceptability and efficacy of 12 weeks of: Smart-device app-based (MyZone) Asynchronous Virtual, Synchronous Virtual, and in-person aerobic training in individuals at risk for Cardiovascular Disease (CVD) who do are not meeting American Heart Association (AHA) guidelines for physical activity. The study aims to 1) Assess the effect of several approaches to remote aerobic training on measures of physical activity, cardiovascular fitness and CVD risk, and 2) Quantitatively and qualitatively evaluate exercise training program fidelity, implementation, effectiveness, and remaining barriers to acceptance. Participants will be asked to undergo Cardiopulmonary Exercise Testing (CPET) before and after 12-weeks of training via one of the 4 modalities (random assignme |
| Who can participate | Inclusion Criteria: 1. \>45 years 2. At risk for CVD (participants must have one or more of the following risk factors: hypertension, hyperlipidemia, Type 2 Diabetes Mellitus, smoking, obesity, family history of premature CVD) 3. Not meeting AHA physical activity guidelines for at least 3 months prior to screening * Hypertension: * Systolic BP ≥140 mm Hg and/or diastolic BP ≥90 mm Hg and/or * Use of anti-hypertensive medication * Hyper / dyslipidemia * LDL cholesterol levels ≥160 mg/dL and/or * HDL cholesterol \<50mg/dL for women, \<40mg/dL for women, in addition to fasting triglycerides \>150mg/dL * Diabetes Mellitus: * Hemoglobin A1c levels ≥6.5%, fasting glucose levels ≥126 mg/dL, or 2-hour glucose levels ≥200 mg/dL after an oral glucose tolerance test and/or * Use of any diabetes medic |
| Ages | 45 Years |
| Sex | All |
| Lead sponsor | NYU Langone Health |
| Locations | New York, New York, United States |
| Start date | 2025-04-06 |
| NCT ID | NCT06931470 |
| Official listing | https://clinicaltrials.gov/study/NCT06931470 |