A Pilot Feasibility and Acceptability Study of Remote ExerciSe Training mOdalities (PRESTO)
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable cardiovascular-diseases
Started Apr 2025
Typical duration for not_applicable cardiovascular-diseases
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 6, 2025
CompletedFirst Submitted
Initial submission to the registry
April 9, 2025
CompletedFirst Posted
Study publicly available on registry
April 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
March 5, 2026
March 1, 2026
1.7 years
April 9, 2025
March 3, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Average minutes of moderate to vigorous physical activity per week
Outcome is measured via wearable technology (smart device).
Up to 13 weeks
Secondary Outcomes (6)
Change in peak oxygen consumption (VO2peak)
Baseline, Week 13
Change in blood pressure
Baseline, Week 13
Change in Body mass index (BMI)
Baseline, Week 13
Change in body fat percentage
Baseline, Week 13
Change in fasting glucose levels
Baseline, Week 13
- +1 more secondary outcomes
Study Arms (4)
In-Person Supervised Aerobic Exercise Intervention (IPSAEI)
ACTIVE COMPARATORParticipants 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.
Remote Synchronous Aerobic Exercise Intervention (RSAEI)
EXPERIMENTALParticipants 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.
Asynchronous Remote Aerobic Exercise Intervention (RASAEI)
EXPERIMENTALParticipants 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.
Remote MyZone Aerobic Exercise Intervention (RMZAEI)
EXPERIMENTALParticipants 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
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.
Live-streamed exercise classes (3 sessions/week) with a trainer providing real-time feedback.
Participants exercise independently and follow a weekly progression plan (3-5 sessions/week (depending on the specific progression)).
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.
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 monitors heart rates and provides immediate feedback for trainers to adjust exercise intensity.
Wearable device (chest strap or armband) that monitors heart rate.
Eligibility Criteria
You may qualify if:
- \>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:
- +3 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Sean P. Heffron, MD
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2025
First Posted
April 17, 2025
Study Start
April 6, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2027
Last Updated
March 5, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to \[Alec Sinatro, MD; alec.sinatro@nyulangone.org\]. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: \[Alec Sinatro, MD; alec.sinatro@nyulangone.org\]. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.