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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In-Person Supervised Aerobic Exercise Intervention (IPSAEI) | Active Comparator | 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. |
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| Remote Synchronous Aerobic Exercise Intervention (RSAEI) | Experimental | 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. |
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| Asynchronous Remote Aerobic Exercise Intervention (RASAEI) | Experimental | 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. |
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| Remote MyZone Aerobic Exercise Intervention (RMZAEI) | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In-person supervised exercise sessions | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Average minutes of moderate to vigorous physical activity per week | Outcome is measured via wearable technology (smart device). | Up to 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, Week 13 |
| Change in blood pressure |
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Inclusion Criteria:
>45 years
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:
Hyper / dyslipidemia
Diabetes Mellitus:
Smoking:
o Current regular tobacco use.
Obesity:
o BMI ≥30 kg/m².
Family History of Premature Cardiovascular Disease:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sean Heffron, MD | Contact | 857-366-1417 | Sean.heffron@nyulangone.org | |
| Ryan Burnett | Contact | 646-856-3492 | Ryan.Burnett@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Sean P. Heffron, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
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.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to [Alec Sinatro, MD; alec.sinatro@nyulangone.org]. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
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| Virtual classes (live-streamed sessions) | Behavioral | Live-streamed exercise classes (3 sessions/week) with a trainer providing real-time feedback. |
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| Self-directed aerobic exercise | Behavioral | Participants exercise independently and follow a weekly progression plan (3-5 sessions/week (depending on the specific progression)). |
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| Myzone mobile application | Device | 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. |
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| Map My Fitness mobile application | Device | 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). |
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| Centralized telemetry | Device | Centralized telemetry monitors heart rates and provides immediate feedback for trainers to adjust exercise intensity. |
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| Myzone heart rate monitor | Device | Wearable device (chest strap or armband) that monitors heart rate. |
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| Baseline, Week 13 |
| Change in Body mass index (BMI) | BMI (kg/m2) will be calculated using measured body weight and height | 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. | Baseline, Week 13 |
| Change in fasting glucose levels | 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. | Baseline, Week 13 |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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