A Pilot Feasibility and Acceptability Study of Remote ExerciSe Training mOdalities (PRESTO)

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT06931470
Status
Recruiting
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Conditions

  • Cardiovascular Diseases

Eligibility Criteria

Sex
ALL
Age
45 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • Virtual classes (live-streamed sessions) — BEHAVIORAL
    Live-streamed exercise classes (3 sessions/week) with a trainer providing real-time feedback.
  • Self-directed aerobic exercise — BEHAVIORAL
    Participants exercise independently and follow a weekly progression plan (3-5 sessions/week (depending on the specific progression)).
  • 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.
  • 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).
  • Centralized telemetry — DEVICE
    Centralized telemetry monitors heart rates and provides immediate feedback for trainers to adjust exercise intensity.
  • Myzone heart rate monitor — DEVICE
    Wearable device (chest strap or armband) that monitors heart rate.

Study Details

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.

Key Dates

Start date
Apr 6, 2025
Status verified
Mar 2026
Primary completion
Dec 1, 2026
Completion
Dec 1, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: In-Person Supervised Aerobic Exercise Intervention (IPSAEI)
    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.
  • Experimental: Remote Synchronous Aerobic Exercise Intervention (RSAEI)
    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.
  • Experimental: Asynchronous Remote Aerobic Exercise Intervention (RASAEI)
    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.
  • Experimental: Remote MyZone Aerobic Exercise Intervention (RMZAEI)
    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.

Primary Outcome Measure

Average minutes of moderate to vigorous physical activity per week [ Time Frame: Up to 13 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

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By research site
NYU Langone Health· New York, NY

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