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NCT Number: NCT06931470

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

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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Key information

Conditions

Cardiovascular Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

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

Treatment and study plan

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.

Primary outcomes

  1. Average minutes of moderate to vigorous physical activity per week

    Time frame: Up to 13 weeks

    Outcome is measured via wearable technology (smart device).

Secondary outcomes

  1. Change in peak oxygen consumption (VO2peak)

    Time frame: Baseline, Week 13

    Peak oxygen consumption (VO2peak) is measured as the highest VO2 recorded during the course of a Cardiopulmonary Exercise Testing (CPET).

  2. Change in blood pressure

    Time frame: Baseline, Week 13

  3. Change in Body mass index (BMI)

    Time frame: Baseline, Week 13

    BMI (kg/m2) will be calculated using measured body weight and height

  4. Change in body fat percentage

    Time frame: Baseline, Week 13

    Body fat percentage will be assessed via multi-frequency bioelectrical impedance analysis (BIA) with 8 tactile electrodes.

  5. Change in fasting glucose levels

    Time frame: Baseline, Week 13

  6. Change in 36-Item Short Form Survey Instrument (SF-36)

    Time frame: Baseline, Week 13

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ryan Burnett

CONTACT

[email protected]

646-856-3492

Sean Heffron, MD

CONTACT

[email protected]

857-366-1417

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

A Pilot Feasibility and Acceptability Study of Remote ExerciSe Training mOdalities

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 17, 2025
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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