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

NYU Langone Health

Status: Enrolling

Conditions: Cardiovascular Diseases

Treatments: Behavioral: Virtual classes (live-streamed sessions); Device: Myzone mobile application; Behavioral: In-person supervised exercise sessions; Behavioral: Self-directed aerobic exercise; Device: Map My Fitness mobile application; Device: Myzone heart rate monitor; Device: Centralized telemetry

Study type: Interventional

Funder types: Other

Identifiers

NCT06931470

24-01067

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 4 patient groups

In-Person Supervised Aerobic Exercise Intervention (IPSAEI)

Active Comparator group

Description:

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.

Treatment:

Device: Centralized telemetry

Behavioral: In-person supervised exercise sessions

Remote Synchronous Aerobic Exercise Intervention (RSAEI)

Experimental group

Description:

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.

Treatment:

Device: Map My Fitness mobile application

Behavioral: Virtual classes (live-streamed sessions)

Asynchronous Remote Aerobic Exercise Intervention (RASAEI)

Experimental group

Description:

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.

Treatment:

Device: Map My Fitness mobile application

Behavioral: Self-directed aerobic exercise

Remote MyZone Aerobic Exercise Intervention (RMZAEI)

Experimental group

Description:

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.

Treatment:

Device: Myzone heart rate monitor

Device: Myzone mobile application