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

Официальное название

A Pilot Feasibility and Acceptability Study of Remote ExerciSe Training mOdalities

Обзор

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.

Вмешательства

• Поведенческое In-person supervised exercise sessions
  Gold-standard, facility-based sessions (3 sessions/week) with an onsite trainer guidance with an exercise Intensity of 40-80% heart rate reserve (HRR) or Rate of Perceived Exertion (RPE) 12-16.
• Поведенческое Virtual classes (live-streamed sessions)
  Live-streamed exercise classes (3 sessions/week) with a trainer providing real-time feedback.
• Поведенческое Self-directed aerobic exercise
  Participants exercise independently and follow a weekly progression plan (3-5 sessions/week (depending on the specific progression)).
• Устройство Myzone mobile application
  Training using the Myzone platform, with participants wearing the Myzone heart rate monitor and using the Myzone app to receive real-time feedback and guidance during exercise sessions (3 days per week). Myzone integrates with its proprietary wearable devices to monitor heart rate and other activity metrics, providing real-time data to users via the app.
• Устройство Map My Fitness mobile application
  Participants will wear a Bluetooth-compatible heart rate monitor (e.g., apple watch/fitbit) that syncs with MapMyFitness. MapMyFitness automatically records workout sessions (duration, distance, heart rate, calories burned, and elevation gain where applicable).
• Устройство Centralized telemetry
  Centralized telemetry monitors heart rates and provides immediate feedback for trainers to adjust exercise intensity.
• Устройство Myzone heart rate monitor
  Wearable device (chest strap or armband) that monitors heart rate.

Первичные конечные точки

• Average minutes of moderate to vigorous physical activity per week [Срок оценки: Up to 13 weeks]

Вторичные конечные точки (6)

• Change in peak oxygen consumption (VO2peak) [Срок оценки: Baseline, Week 13]
• Change in blood pressure [Срок оценки: Baseline, Week 13]
• Change in Body mass index (BMI) [Срок оценки: Baseline, Week 13]
• Change in body fat percentage [Срок оценки: Baseline, Week 13]
• Change in fasting glucose levels [Срок оценки: Baseline, Week 13]
• Change in 36-Item Short Form Survey Instrument (SF-36) [Срок оценки: Baseline, Week 13]

Критерии участия

Критерии включения

• >45 years
• 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)
• 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.

Критерии исключения

• Established diagnosis of atherosclerotic CVD
• 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)
• Pregnant or anticipating pregnancy
• Plan to be away for >2 weeks during the intervention period
• Presence of any biopsychosocial factors that the principal investigator deems as having significant potential to interfere with effective study participation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• NYU Langone Health — New York

Идентификаторы

NCT: NCT06931470 · 24-01067

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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