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

Not Applicable

Recruiting

• Conditions: Cardiovascular Diseases

• Registration Number: NCT06931470
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study Start: 2025-04-06
• Study First Submitted: 2025-04-09
• Study First Submitted QC: 2025-04-09
• Last Update Submitted: 2025-04-09
• Study First Posted: 2025-04-17
• Last Update Posted: 2025-04-17
• Primary Completion: 2025-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Average minutes of moderate to vigorous physical activity per week	Up to 13 weeks	Outcome is measured via wearable technology (smart device).

Secondary Outcome Measures

Name	Time	Method
Change in peak oxygen consumption (VO2peak)	Baseline, Week 13	Peak oxygen consumption (VO2peak) is measured as the highest VO2 recorded during the course of a Cardiopulmonary Exercise Testing (CPET).
Change in blood pressure	Baseline, Week 13
Change in Body mass index (BMI)	Baseline, Week 13	BMI (kg/m2) will be calculated using measured body weight and height
Change in body fat percentage	Baseline, Week 13	Body fat percentage will be assessed via multi-frequency bioelectrical impedance analysis (BIA) with 8 tactile electrodes.
Change in fasting glucose levels	Baseline, Week 13
Change in 36-Item Short Form Survey Instrument (SF-36)	Baseline, Week 13	SF-36 captures mental health, general health perception, emotional, and social role functioning. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. Higher scores indicate a more favorable health state.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States