Recruiting

Remote Exercise

Sponsor:

NYU Langone Health

Code:

NCT06931470

Conditions

Cardiovascular Diseases

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

Interventions

In-person supervised exercise sessions

Virtual classes (live-streamed sessions)

Self-directed aerobic exercise

Myzone mobile application

Map My Fitness mobile application

Study Details

Brief 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

Study ID

NCT06931470

Start date

Apr 6, 2025

Status verified date

Mar, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. >45 years
2. 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)
3. 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:

1. Established diagnosis of atherosclerotic CVD
2. 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)
3. Pregnant or anticipating pregnancy
4. Plan to be away for >2 weeks during the intervention period
5. Presence of any biopsychosocial factors that the principal investigator deems as having significant potential to interfere with effective study participation

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

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.

Virtual classes (live-streamed sessions)

Live-streamed exercise classes (3 sessions/week) with a trainer providing real-time feedback.

Self-directed aerobic exercise

Participants exercise independently and follow a weekly progression plan (3-5 sessions/week (depending on the specific progression)).

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.

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).

Centralized telemetry

Centralized telemetry monitors heart rates and provides immediate feedback for trainers to adjust exercise intensity.

Myzone heart rate monitor

Wearable device (chest strap or armband) that monitors heart rate.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Sean Heffron, MD

857-366-1417Sean.heffron@nyulangone.org

Ryan Burnett

646-856-3492Ryan.Burnett@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-03-05.