Cardiac Telerehabilitation Versus In-person After Acute Coronary Syndrome: Randomized Clinical Trial TELECOR Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- % patients with a positive result in the composite variable integrating different targets for secondary prevention in cardiovascular disease and lifestyle habits
研究概览
简要总结
The purpose of this trial is to evaluate wether a cardiac Telerehabilitation programme is as effective as an in-person rehabilitation program after acute coronary syndrome in the control of cardiovascular risk factors
详细描述
The purpose of this trial is to evaluate wether a cardiac Telerehabilitation programme is as effective as an in-person rehabilitation program after acute coronary syndrome in the control of cardiovascular risk factors via the following variables: % patients with a positive result in the composite variable integrating different targets for secondary prevention in cardiovascular disease and lifestyle habits; Adherence to cardiac rehabilitation program; Adherence to pharmacological treatment; Quality of Life improvement ; Anxiety and depression; Satisfaction rate; Functional capacity; Cardiac cause hospitalization; Emergency visits; and Angioplasty revascularization procedure.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute myocardial infarct prior to 2 months
- •Killip I-II classification
- •No previous myocardial infarction
- •No angina pectoris
- •No ischemia in complementary explorations
- •Normal arterial pressure response during stress test.
- •No relevant arrythmias
- •Left ventricular ejection fraction >= 35%
- •Functional capacity >5 METS
- •Signing of the inform consent
排除标准
- •Physical or intellectual disability that prevents patients from enrolling in a cardiac rehabilitation program
- •Impossibility for digital media use
研究组 & 干预措施
Tele-rehabilitation
Patients with a myocardial infarction candidates to a rehabilitation program, will be enrolled. The patient is guided via a face-to-face telematic call to perform the cardiac rehabilitation exercises and life style education.
干预措施: Experimental: Cardiac tele-rehabilitation (Behavioral)
In person cardiac rehabilitation
Patients with a myocardial infarction candidates to a rehabilitation program, will be enrolled. The patient attends an in-person cardiac rehabilitation exercises and life style education at the hospital.
干预措施: Other: Control, in person cardiac rehabilitation (Behavioral)
结局指标
主要结局
% patients with a positive result in the composite variable integrating different targets for secondary prevention in cardiovascular disease and lifestyle habits
时间窗: • (%) [Time Frame: 0-2months +- 30 days-6 months +-7days]
Variable for Cardiovascular Risk Factor Control: Composite Variable Integrating Different Targets for Secondary Prevention in Cardiovascular Disease and Lifestyle Habits 1. Blood pressure \<140/90 mmHg 2. Maintaining normal weight or a 5% reduction in body weight if BMI \> 25 kg/m2 3. Abdominal circumference \<88 cm in women and \<102 cm in men 4. LDL \<50 mg/dl and a reduction of \>50% in initial LDL levels 5. Smoking cessation 6. Adherence to a heart-healthy diet (PREDIMED Questionnaire\* ≥7) 7. Adherence to physical activity level: 6,000-10,000 steps/day or moderate-high IPAQ\*\* result (International Physical Activity Questionnaire)
次要结局
- Adherence to cardiac rehabilitation program(2 months +-30 day)
- Adherence to pharmacological treatment(0-2months +- 30 days-6 months +-7days)
- Quality of Life improvement(0-2months +- 30 days-6 months +-7days)
- Anxiety and depression(0-2months +- 30 days-6 months +-7days)
- Satisfaction rate(2months +- 30 days)
- Functional capacity(0-2months +- 30 days)
- Cardiac cause hospitalization(6 months +-7days)
- Emergency visits(6 months +-7days)
- Angioplasty revascularization procedure(0-2months +- 30 days)