A Pilot Feasibility and Acceptability Study of Remote ExerciSe Training mOdalities
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Average minutes of moderate to vigorous physical activity per week
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •o Current regular tobacco use.
- •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.
排除标准
- •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
研究组 & 干预措施
In-Person Supervised Aerobic Exercise Intervention (IPSAEI)
Participants engage in supervised exercise sessions at a facility, where trainers use centralized telemetry to monitor heart rates and provide immediate feedback and adjustments to exercise intensity.
干预措施: In-person supervised exercise sessions (Behavioral)
In-Person Supervised Aerobic Exercise Intervention (IPSAEI)
Participants engage in supervised exercise sessions at a facility, where trainers use centralized telemetry to monitor heart rates and provide immediate feedback and adjustments to exercise intensity.
干预措施: Centralized telemetry (Device)
Remote Synchronous Aerobic Exercise Intervention (RSAEI)
Participants join live-streamed exercise sessions led by a virtual trainer. Real-time heart rate monitoring via an app allows the trainer to provide immediate feedback and adjust exercise intensity as needed.
干预措施: Virtual classes (live-streamed sessions) (Behavioral)
Remote Synchronous Aerobic Exercise Intervention (RSAEI)
Participants join live-streamed exercise sessions led by a virtual trainer. Real-time heart rate monitoring via an app allows the trainer to provide immediate feedback and adjust exercise intensity as needed.
干预措施: Map My Fitness mobile application (Device)
Asynchronous Remote Aerobic Exercise Intervention (RASAEI)
Participants exercise independently while monitoring their heart rate in real time using the Map My Fitness app. They adjust their intensity based on personal targets and receive periodic feedback from a trainer during scheduled check-ins.
干预措施: Self-directed aerobic exercise (Behavioral)
Asynchronous Remote Aerobic Exercise Intervention (RASAEI)
Participants exercise independently while monitoring their heart rate in real time using the Map My Fitness app. They adjust their intensity based on personal targets and receive periodic feedback from a trainer during scheduled check-ins.
干预措施: Map My Fitness mobile application (Device)
Remote MyZone Aerobic Exercise Intervention (RMZAEI)
Participants use the Myzone heart rate monitor and app to receive real-time feedback on their exercise intensity. The Myzone platform provides automated guidance on intensity adjustments, goal setting, and motivational support through features like challenges and social connectivity.
干预措施: Myzone heart rate monitor (Device)
Remote MyZone Aerobic Exercise Intervention (RMZAEI)
Participants use the Myzone heart rate monitor and app to receive real-time feedback on their exercise intensity. The Myzone platform provides automated guidance on intensity adjustments, goal setting, and motivational support through features like challenges and social connectivity.
干预措施: Myzone mobile application (Device)
结局指标
主要结局
Average minutes of moderate to vigorous physical activity per week
时间窗: Up to 13 weeks
Outcome is measured via wearable technology (smart device).
次要结局
- Change in fasting glucose levels(Baseline, Week 13)
- Change in Body mass index (BMI)(Baseline, Week 13)
- Change in peak oxygen consumption (VO2peak)(Baseline, Week 13)
- Change in blood pressure(Baseline, Week 13)
- Change in body fat percentage(Baseline, Week 13)
- Change in 36-Item Short Form Survey Instrument (SF-36)(Baseline, Week 13)