NCT05238103已完成不适用
Impact of a Mobile Technology Enabled Corrie Cardiac Rehabilitation Program on Functional Status and Cardiovascular Outcomes (mTECH-Rehab): A Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 259
- 试验地点
- 2
- 主要终点
- 6-minute Walking Distance (Meters)
研究概览
简要总结
In this randomized clinical trial, the researchers are investigating whether a multi-component virtual/hybrid cardiac rehabilitation program will improve functional status, cholesterol level, overall cardiovascular health, individual risk factors, quality of life and mental health for patients who have recently been diagnosed with myocardial infarction, received a coronary stent, underwent heart surgery or catheter-based valve replacement, as compared to traditional, center-based cardiac rehabilitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Individuals admitted to the hospital for the following conditions or interventions during the index admission: Acute myocardial infarction (STEMI or NSTEMI type 1), Coronary artery bypass grafting (CABG), and Coronary artery angioplasty/stenting (PCI), Heart valve surgery, catheter-based aortic valve replacement (TAVR).
- •Exclusion Criteria
- •Non-English speaking
- •Symptomatic severe aortic stenosis or other severe valvular disease
- •Physical disability that would preclude safe and adequate exercise performance
- •Hypertrophic obstructive cardiomyopathy with peak resting left ventricular outflow gradient of >25 mmHg
- •Known aortic dissection
- •Severe resting arterial hypertension (Systolic blood pressure >200 mmHg or diastolic BP >110mmHg) at baseline assessment
- •Mental impairment leading to inability to cooperate with study procedures
- •Untreated high degree atrioventricular block
- •Atrial fibrillation with uncontrolled ventricular rate (Heart rate >110 at rest) at baseline assessment
- •History of cardiac arrest or sudden death
- •Myocardial infarction or cardiac surgery complications with cardiogenic shock and/or congestive heart failure and/or signs/symptoms of post-procedure ischemia
- •Left ventricular ejection fraction <40%
- •History of Clinically significant depression
- •Visual or hearing impairment which precludes the use of the intervention
- •Presence of cardiac defibrillator
- •Incomplete revascularization procedure
- •History of one or more episodes of falls in the last year
- •Pregnancy
- •If patients are deemed clinically unstable and unable to participate at the time of initial screening, the research team member may return at a later date to determine whether this status has changed.
排除标准
- 未提供
结局指标
主要结局
6-minute Walking Distance (Meters)
时间窗: 12 weeks after randomization
Mean difference in 6 minute walk distance, between Intervention and Control groups, as measured at final study visit occurring at 12 weeks after randomization.
次要结局
- Composite Cardiovascular Health Metric for Secondary Prevention(12 weeks after randomization)
- Blood Pressure (mmHg)(12 weeks after randomization)
- Low Density Lipoprotein - Cholesterol (LDL-C)(12 weeks after randomization)
- Glycosylated Hemoglobin (HbA1c)(12 weeks after randomization)
- Body Mass Index (kg/m^2)(12 weeks after randomization)
- Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10(12 weeks after randomization)
- Blood Pressure Control(12 weeks after randomization)
- Cholesterol (LDL-C) Control(12 weeks after randomization)
- Diabetes Control(12 weeks after randomization)
- Weight (BMI) Categories(12 weeks after randomization)
- Physical Activity Categories(12 weeks after randomization)
- Diet Categories(12 weeks after randomization)
- Tobacco Use(12 weeks after randomization)
- Cardiac Rehabilitation Engagement(12 weeks after randomization)
研究者
研究点 (2)
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