RecruitingNot ApplicableNCT06931470

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

A Pilot Feasibility and Acceptability Study of Remote ExerciSe Training mOdalities

Sponsor

NYU Langone Health

Enrollment

30 participants

Start Date

Apr 6, 2025

Study Type

INTERVENTIONAL

Conditions

Cardiovascular Diseases

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.

Eligibility

Min Age: 45 Years

Inclusion Criteria18

>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 Criteria5

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

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Interventions

BEHAVIORALIn-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.

BEHAVIORALVirtual classes (live-streamed sessions)

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

BEHAVIORALSelf-directed aerobic exercise

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

DEVICEMyzone 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.

DEVICEMap 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).

DEVICECentralized telemetry

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

DEVICEMyzone heart rate monitor

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