Clinical trial NCT06931470: A Pilot Feasibility and Acceptability Study of Remote ExerciSe Training mOdalities (PRESTO)
Official title: A Pilot Feasibility and Acceptability Study of Remote ExerciSe Training mOdalities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2025-04-17
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Primary outcomes:
measure: Average minutes of moderate to vigorous physical activity per week
timeFrame: Up to 13 weeks
Secondary outcomes:
measure: Change in peak oxygen consumption (VO2peak)
timeFrame: Baseline, Week 13
measure: Change in blood pressure
timeFrame: Baseline, Week 13
measure: Change in Body mass index (BMI)
timeFrame: Baseline, Week 13
measure: Change in body fat percentage
timeFrame: Baseline, Week 13
measure: Change in fasting glucose levels
timeFrame: Baseline, Week 13
measure: Change in 36-Item Short Form Survey Instrument (SF-36)
timeFrame: Baseline, Week 13
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Sean P. Heffron, MD
role: PRINCIPAL_INVESTIGATOR
References: