A Pilot Feasibility and Acceptability Study of Remote ExerciSe Training mOdalities (PRESTO)
NCT ID: NCT06931470
Last Updated: 2025-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2025-04-06
2026-12-01
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
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.
Centralized telemetry
Centralized telemetry monitors heart rates and provides immediate feedback for trainers to adjust exercise intensity.
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.
Virtual classes (live-streamed sessions)
Live-streamed exercise classes (3 sessions/week) with a trainer providing real-time feedback.
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).
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.
Self-directed aerobic exercise
Participants exercise independently and follow a weekly progression plan (3-5 sessions/week (depending on the specific progression)).
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).
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.
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.
Myzone heart rate monitor
Wearable device (chest strap or armband) that monitors heart rate.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
45 Years
ALL
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Sean P. Heffron, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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NYU Langone Health
New York, New York, United States
Countries
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Central Contacts
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Other Identifiers
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24-01067
Identifier Type: -
Identifier Source: org_study_id
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