Cardiovascular Diseases
Conditions
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.
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.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average minutes of moderate to vigorous physical activity per week | Up to 13 weeks | Outcome is measured via wearable technology (smart device). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in fasting glucose levels | Baseline, Week 13 | — |
| Change in 36-Item Short Form Survey Instrument (SF-36) | 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. |
| Change in body fat percentage | Baseline, Week 13 | Body fat percentage will be assessed via multi-frequency bioelectrical impedance analysis (BIA) with 8 tactile electrodes. |
| Change in peak oxygen consumption (VO2peak) | Baseline, Week 13 | Peak oxygen consumption (VO2peak) is measured as the highest VO2 recorded during the course of a Cardiopulmonary Exercise Testing (CPET). |
| Change in blood pressure | Baseline, Week 13 | — |
| Change in Body mass index (BMI) | Baseline, Week 13 | BMI (kg/m2) will be calculated using measured body weight and height |
Countries
United States
Contacts
CONTACTSean Heffron, MD
CONTACTRyan Burnett
PRINCIPAL_INVESTIGATORSean P. Heffron, MD
NYU Langone Health
Outcome results
None listed