BE-PHIT: a Behavioral Science-Enhanced PHysician-led Remote Group Exercise InTervention for Women With Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Change in minutes of moderate-to-vigorous intensity physical activity (MVPA)/week
研究概览
简要总结
Ischemic heart disease is the leading cause of death in the United States and worldwide (Nowbar et al., 2019). Exercise has been shown to be effective in preventing repeat heart attacks, hospitalizations and death among heart attack survivors (Lawler et al., 2011). But, few heart attack survivors -- particularly women -- get the recommended amount of physical activity (Minges et al., 2017; Gorczyca et al., 2017). The goal of this pilot study is to test the potential of an innovative new doctor-led exercise program to improve physical activity and quality of life for women who have had heart attacks in the past. Women who take part in the study will be randomly assigned to participation in the exercise program (which will consist of three 45-minute exercise sessions on Zoom per week) or usual care (attending medical appointments and following doctors' recommendations). All participants will be asked to wear Fitbit activity trackers to track steps every day, to use blood pressure cuffs to measure blood pressure at home, and complete a brief set of surveys at the beginning of the study, after 4 weeks, and after 12 weeks.
详细描述
This study will employ a pilot randomized controlled trial (RCT) design to compare an intervention group and a control group receiving usual care.
The pilot RCT will include 60 sedentary adult women with a history of stable coronary artery disease (CAD) who will be randomized to the intervention arm (4-week physician-led remote exercise program) or usual care. The primary outcome will be change in minutes/week of moderate-to-vigorous physical activity (MVPA) at 4 weeks, which will be measured with Fitbit trackers provided to all participants. Secondary outcomes will include change in MVPA at 12 weeks, the proportion of patients achieving guidelines-recommended volumes of physical activity (PA) at 4 and 12 weeks, change in minutes of sedentary time per week at 4 and 12 weeks, change in cardiometabolic health measures (e.g. self-reported weight, blood pressure, and resting heart rate), and change in survey-based measures of self determination, intrinsic motivation, well-being, and quality of life. Additional feasibility outcomes will include satisfaction, and likelihood to recommend.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 40-80 years
- •Diagnosis of coronary artery disease that meets criteria for one of the following:
- •a. Stable obstructive CAD i. A history of myocardial infarction (MI) at least 12 months prior to enrollment, history of coronary artery bypass graft surgery (CABG), and/or history of percutaneous coronary intervention (PCI) with
- •Coronary angiogram completed at time of diagnosis with MI or completion of CABG/PCI AND
- •Stress test (completed within 12 months after diagnosis of MI OR within 5 years prior to enrollment) OR
- •Absence of anginal symptoms following revascularization ii. Previous imaging (e.g. coronary computed tomographic angiography [CCTA] or coronary angiography) demonstrating any stenosis 50% or greater in the left main coronary artery, 70% or greater in any other coronary artery, or both.
- •b. Non-obstructive CAD i. Previous imaging (e.g. CCTA or coronary angiography) with/without additional stress testing demonstrating coronary artery stenosis 1 to 49% in the left main coronary artery or 1-70% in any other epicardial coronary artery with or without stress testing negative for ischemia.
- •ii. Previous imaging (e.g. calcium scoring or conventional computed tomography) demonstrating calcified coronary artery plaque with or without stress testing negative for ischemia.
- •Completed visit with Mass General Brigham (MGB) cardiologist within 12 months prior to enrollment
- •Self-reported physical inactivity (any amount of PA less than guideline-recommended amount of 150 minutes/week of at least moderate intensity aerobic exercise)10 as reported on the brief "Exercise as a Vital Sign" (EVS) instrument11
- •Ability to ambulate independently
- •Possession of and ability to use a computer and/or smart device with video conferencing capability
- •Possession of and willing to use a home scale daily.
- •Willing to use a Fitbit activity tracker daily.
排除标准
- •A history of conditions that limit or contraindicate exercise (e.g., myocardial infarction within 48 hours, unstable angina, heart failure with reduced ejection fraction, severe aortic stenosis, uncontrolled cardiac arrhythmias, myocarditis, acute pulmonary embolism, severe pulmonary hypertension, aortic dissection, hypertrophic obstructive cardiomyopathy, hypertension greater than 200/110 mmHg, known obstruction of the left coronary artery)
- •Musculoskeletal or plantar wounds/injuries
- •Severe mental or cognitive disabilities
- •Inability to speak English
结局指标
主要结局
Change in minutes of moderate-to-vigorous intensity physical activity (MVPA)/week
时间窗: 4 weeks
This will be assessed based on documented physical activity on Fitbit devices provided to all participants. A third-party research application program interface (API) called Fitabase (Small Steps Labs, LLC, San Diego, CA) will be used to exporting the data from the Fitbit at 60-second sampling intervals. Using its proprietary algorithm, the Fitbit tracker will convert raw acceleration data into activity counts in 60-s sampling intervals that define activity intensities as 0 = sedentary, 1 = light PA, 2 = moderate PA, and 3 = vigorous PA. MVPA minutes per week will be extracted through Fitabase (Semanik et al., 2019).
次要结局
- Change in minutes of moderate-to-vigorous intensity physical activity (MVPA)/week(12 weeks)
- Proportion of patients achieving guideline-recommended volume of physical activity(4 weeks and 12 weeks)
- Change in minutes of sedentary time/week(4 weeks and 12 weeks)
研究者
Simin G. Lee
Physician
Brigham and Women's Hospital