Effectiveness of a Hybrid Cardiac Rehabilitation Program for Coronary Artery Disease Patients. Randomized, Multicenter, Non-inferiority Clinical Trial in a Low-resource Setting. HYCARET Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 7
- 主要终点
- Recurrent cardiovascular events
研究概览
简要总结
This clinical trial aim to evaluate if the prevention of recurrent cardiovascular events is not inferior in the hybrid mobile and exercise-based cardiac rehabilitation programs in comparison to the standard cardiac rehabilitation program.
详细描述
Background: Cardiac rehabilitation (CR) programs are well established, as their effectiveness and cost-effectiveness is proven. In spite of this, CR remains under-utilized, especially in middle and low-resource settings such as Latin America. As the highest rates of mortality and disability-adjusted life-years in the world are caused by cardiovascular diseases, with a corresponding major impact on economies, there is an urgent need to create more accessible CR delivery models to reach all patients in need. This trial aims to evaluate if the prevention of recurrent cardiovascular events is not inferior in a hybrid cardiac rehabilitation program compared to a standard program.
Method and analysis: A non-inferiority, pragmatic, multicenter, parallel (1:1), single blinded, randomized clinical trial will be conducted. 314 patients with coronary artery disease will be recruited consecutively. Participants will be randomized to hybrid or standard rehabilitation programs. The hybrid CR program includes 10 supervised exercise sessions and individualized lifestyle counseling by a physiotherapist, with a transition after 4-6 weeks to unsupervised delivery via text messages and phone calls. The standard CR consists of 18-22 supervised exercise sessions, as well as group education sessions about lifestyle. The intervention in both groups will be by 12 weeks. The primary outcome is a composite of cardiovascular mortality and hospitalizations due to cardiovascular causes. Secondary outcomes are cardiovascular risk factor control, exercise capacity, adherence to physical activity and diet recommendations, health-related quality of life and exercise-related adverse events. The outcomes will be measured at the end of intervention, at 6 months, and at 12-month follow-up from recruitment. The primary outcome will be tracked through the end of the trial. The sample size was calculated considering 5% of the non-inferiority limit. Per protocol and intention-to-treat analysis will be undertaken. A survival analysis will be run for the primary outcome.
Ethics and dissemination: The corresponding ethical committees at the sponsor institution and each center where participants will be recruited approved the study protocol and the Informed Consent form. Research findings will be published in peer-reviewed journals. Additionally, scientific results will be disseminated among stakeholders and national policy-makers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, 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
- •Age 18 year old or over.
- •Patient with coronary artery disease, including Acute Coronary Syndrome (Unstable Angina, Myocardial infarction with or without ST elevation) or stable coronary vessel disease diagnosed by angiography or a stress test.
- •Patient treated medically (i.e., medication only) or by thrombolysis, angioplasty, or revascularization surgery.
- •Patient with physician referral, that can start CR between 2 weeks and 2 months from their event, diagnosis or procedure.
- •Patient able to attend the health center almost twice a week over three months.
- •Patient owns a mobile phone.
- •Patient that consents to participate in the study through signing an informed consent form.
排除标准
- •Patient has a planned repeat cardiac or other procedure in next 12 months.
- •Explicit contraindication to perform exercise based on American College of Sport Medicine.
- •Patients with comorbidities that would interfere with ability to engage in cardiac rehabilitation such as dementia, blindness, deafness, serious mental illness, or frailty.
- •Musculoskeletal disease that precludes the patient from performing exercise
结局指标
主要结局
Recurrent cardiovascular events
时间窗: 12 months (or more for first recruited participants, but until 36 months).
Composite of cardiovascular mortality (defined as death by stroke, myocardial infarction or heart failure) and hospitalizations due to a cardiovascular cause (non-fatal stroke, non-fatal myocardial infarction, heart failure, and need for revascularization surgery)
次要结局
- Adherence to diet recommendations(Baseline, end of intervention (8-12 weeks), 6 months, and 12 months.)
- Functional exercise capacity(Baseline, end of intervention (8-12 weeks), 6 months, and 12 months)
- Adherence to physical activity recommendations(Baseline, end of intervention (8-12 weeks), 6 months, and 12 months.)
- Body Mass Index (BMI)(Baseline, end of intervention (8-12 weeks), 6 months, and 12 months)
- Waist circumference(Baseline, end of intervention (8-12 weeks), 6 months, and 12 months)
- Blood Pressure(Baseline, end of intervention (8-12 weeks), 6 months, and 12 months)
- Adherence(End of intervention (8-12 weeks))
- Health-related quality of life(Baseline, end of intervention (8-12 weeks), 6 months, and 12 months.)
- Grip strength(Baseline, end of intervention (8-12 weeks), 6 months, and 12 months)
- Return-to-work(End of intervention (8-12 weeks), 6 months, and 12 months)
- Exercise related adverse events(End of intervention (8-12 weeks))
研究者
Pamela Serón
Professor
Universidad de La Frontera