Remote exercise training for individuals at risk of cardiovascular disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the acceptability and efficacy of 12 weeks of various remote aerobic training modalities, including in-person sessions and virtual classes, for individuals at risk for cardiovascular disease who are not meeting physical activity guidelines. Participants will be randomly assigned to one of four training approaches and will undergo cardiopulmonary exercise testing before and after the intervention. The study aims to assess the impact of these training methods on physical activity levels, cardiovascular fitness, and overall CVD risk, while also evaluating the fidelity and acceptance of the exercise programs.

Why it matters

Who can join: the full rules

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

Where it's running

• NYU Langone Health
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Sean P. Heffron, MD — NYU Langone Health
• Study coordinator: Sean Heffron, MD
• Email: Sean.heffron@nyulangone.org
• Phone: 857-366-1417

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.