Remote exercise training for individuals at risk of cardiovascular disease

A Pilot Feasibility and Acceptability Study of Remote ExerciSe Training mOdalities

This study is testing different remote exercise programs to see if they can help people at risk for heart disease get more active and improve their heart health.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 45 Years and up
• Sex: All
• Sponsor: NYU Langone Health (Academic / other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT06931470 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are individuals over 45 years old with one or more risk factors for cardiovascular disease who have not met physical activity guidelines for at least three months.

Not a fit: Patients who are already meeting AHA physical activity guidelines or do not have any risk factors for cardiovascular disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide effective remote exercise solutions to improve cardiovascular health in at-risk individuals.

How similar studies have performed: Other studies have shown success with remote exercise interventions for improving cardiovascular health, indicating that this approach is promising.

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

Where this trial is running

New York, New York

• 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

Conditions Cardiovascular Diseases