Status:
RECRUITING
A Pilot Feasibility and Acceptability Study of Remote ExerciSe Training mOdalities (PRESTO)
Lead Sponsor:
NYU Langone Health
Conditions:
Cardiovascular Diseases
Eligibility:
All Genders
45+ years
Phase:
NA
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 r...
Eligibility Criteria
Inclusion
- \>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:
- 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
- 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
Key Trial Info
Start Date :
April 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06931470
Start Date
April 6 2025
End Date
December 1 2026
Last Update
April 17 2025
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10016