A Pilot Feasibility and Acceptability Study of Remote ExerciSe Training mOdalities (PRESTO)

Last updated: April 9, 2025
Sponsor: NYU Langone Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vascular Diseases

Treatment

Self-directed aerobic exercise

Map My Fitness mobile application

Virtual classes (live-streamed sessions)

Clinical Study ID

NCT06931470
24-01067
  • Ages > 45
  • All Genders

Study 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

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, familyhistory of premature CVD)

  3. Not meeting AHA physical activity guidelines for at least 3 months prior toscreening

  • 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 tofasting triglycerides >150mg/dL

  • Diabetes Mellitus:

  • Hemoglobin A1c levels ≥6.5%, fasting glucose levels ≥126 mg/dL, or 2-hourglucose 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 beforeage 55 for biological males or age 65 for biological females.

Exclusion

Exclusion Criteria:

  1. Established diagnosis of atherosclerotic CVD

  2. Presence of any serious medical conditions that would not allow safe participationin 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 ashaving significant potential to interfere with effective study participation

Study Design

Total Participants: 30
Treatment Group(s): 7
Primary Treatment: Self-directed aerobic exercise
Phase:
Study Start date:
April 06, 2025
Estimated Completion Date:
December 01, 2026

Connect with a study center

  • NYU Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

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