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

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 assignment) listed above. They will respond to questions regarding acceptability of the interventions.

Conditions

• Cardiovascular Diseases

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.

Sponsors & Collaborators

• NYU Langone Health

  lead OTHER

Principal Investigators

• Sean P. Heffron, MD · NYU Langone Health

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

45 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-06

Primary Completion

2026-12-01

Completion

2027-12-01

Countries

• United States

Study Locations