An interventional study of In-person supervised exercise sessions and Virtual classes (live-streamed sessions) in Cardiovascular Diseases, sponsored by NYU Langone Health. Recruiting at 1 site in United States. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-03-05.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Prevention
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's planned enrollment of 30 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Not meeting AHA physical activity guidelines for at least 3 months prior to screening
Hypertension:
Hyper / dyslipidemia
Diabetes Mellitus:
Smoking:
o Current regular tobacco use.
Obesity:
o BMI ≥30 kg/m².
Family History of Premature Cardiovascular Disease:
Exclusion Criteria:
Participants engage in supervised exercise sessions at a facility, where trainers use centralized telemetry to monitor heart rates and provide immediate feedback and adjustments to exercise intensity.
Behavioral: In-person supervised exercise sessions · Device: Centralized telemetry
Participants join live-streamed exercise sessions led by a virtual trainer. Real-time heart rate monitoring via an app allows the trainer to provide immediate feedback and adjust exercise intensity as needed.
Behavioral: Virtual classes (live-streamed sessions) · Device: Map My Fitness mobile application
Participants exercise independently while monitoring their heart rate in real time using the Map My Fitness app. They adjust their intensity based on personal targets and receive periodic feedback from a trainer during scheduled check-ins.
Behavioral: Self-directed aerobic exercise · Device: Map My Fitness mobile application
Participants use the Myzone heart rate monitor and app to receive real-time feedback on their exercise intensity. The Myzone platform provides automated guidance on intensity adjustments, goal setting, and motivational support through features like challenges and social connectivity.
Device: Myzone mobile application · Device: Myzone heart rate monitor
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.
Live-streamed exercise classes (3 sessions/week) with a trainer providing real-time feedback.
Participants exercise independently and follow a weekly progression plan (3-5 sessions/week (depending on the specific progression)).
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.
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).
Centralized telemetry monitors heart rates and provides immediate feedback for trainers to adjust exercise intensity.
Wearable device (chest strap or armband) that monitors heart rate.
Average minutes of moderate to vigorous physical activity per week
Outcome is measured via wearable technology (smart device).
Time frame: Up to 13 weeks
Change in peak oxygen consumption (VO2peak)
Peak oxygen consumption (VO2peak) is measured as the highest VO2 recorded during the course of a Cardiopulmonary Exercise Testing (CPET).
Time frame: Baseline, Week 13
Change in blood pressure
Time frame: Baseline, Week 13
Change in Body mass index (BMI)
BMI (kg/m2) will be calculated using measured body weight and height
Time frame: Baseline, Week 13
Change in body fat percentage
Body fat percentage will be assessed via multi-frequency bioelectrical impedance analysis (BIA) with 8 tactile electrodes.
Time frame: Baseline, Week 13
Change in fasting glucose levels
Time frame: Baseline, Week 13
Change in 36-Item Short Form Survey Instrument (SF-36)
SF-36 captures mental health, general health perception, emotional, and social role functioning. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. Higher scores indicate a more favorable health state.
Time frame: Baseline, Week 13
Plan to share: Yes — The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: \[Alec Sinatro, MD; alec.sinatro@nyulangone.org\]. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
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