NCT06931470 A Pilot Feasibility and Acceptability Study of Remote ExerciSe Training mOdalities (PRESTO)
| NCT ID | NCT06931470 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NYU Langone Health |
| Condition | Cardiovascular Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-04-06 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-04-06 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Sean P. Heffron, MD
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT06931470 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, studying Cardiovascular Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06931470 currently recruiting?
Yes, NCT06931470 is actively recruiting participants. Contact the research team at Sean.heffron@nyulangone.org for enrollment information.
Where is the NCT06931470 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06931470 clinical trial?
NCT06931470 is sponsored by NYU Langone Health. The principal investigator is Sean P. Heffron, MD at NYU Langone Health. The trial plans to enroll 30 participants.