NCT06931470 · NYU Langone Health
A Pilot Feasibility and Acceptability Study of Remote ExerciSe Training mOdalities (PRESTO)
What this study is about
This study will investigate the acceptability and effectiveness 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.
View original scientific description
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 assignment) listed above. They will respond to questions regarding acceptability of the interventions.
Interventions
BEHAVIORAL
In-person supervised exercise sessions
Gold-standard, facility-based sessions (3 sessions/week) with an onsite trainer guidance with an exercise Intensity of 40-80% heart rate reserve (HRR) or Rate of Perceived Exertion (RPE) 12-16.
BEHAVIORAL
Virtual classes (live-streamed sessions)
Live-streamed exercise classes (3 sessions/week) with a trainer providing real-time feedback.
BEHAVIORAL
Self-directed aerobic exercise
Participants exercise independently and follow a weekly progression plan (3-5 sessions/week (depending on the specific progression)).
DEVICE
Myzone mobile application
Training using the Myzone platform, with participants wearing the Myzone heart rate monitor and using the Myzone app to receive real-time feedback and guidance during exercise sessions (3 days per week). Myzone integrates with its proprietary wearable devices to monitor heart rate and other activity metrics, providing real-time data to users via the app.
DEVICE
Map My Fitness mobile application
Participants will wear a Bluetooth-compatible heart rate monitor (e.g., apple watch/fitbit) that syncs with MapMyFitness. MapMyFitness automatically records workout sessions (duration, distance, heart rate, calories burned, and elevation gain where applicable).
DEVICE
Centralized telemetry
Centralized telemetry monitors heart rates and provides immediate feedback for trainers to adjust exercise intensity.
DEVICE
Myzone heart rate monitor
Wearable device (chest strap or armband) that monitors heart rate.
Primary outcome measures
Average minutes of moderate to vigorous physical activity per week
Time frame: Up to 13 weeks
Outcome is measured via wearable technology (smart device).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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)
- 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 medication
- Smoking: o Current regular tobacco use.
- Obesity: o BMI ≥30 kg/m².
- Family History of Premature Cardiovascular Disease:
- Having a first-degree relative (parent, sibling) who developed CVD before age 55 for biological males or age 65 for biological females.
Exclusion criteria
- Established diagnosis of atherosclerotic CVD
- Presence of any serious medical conditions that would not allow safe participation in exercise according to the American College of Sports Medicine (ACSM) and the AHA (56-58)
- Pregnant or anticipating pregnancy
- Plan to be away for \>2 weeks during the intervention period
- Presence of any biopsychosocial factors that the principal investigator deems as having significant potential to interfere with effective study participation
Where
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 5, 2026 · Source of record for eligibility and locations