Early-phase Exercise-based Comprehensive Cardiac Rehabilitation Program After Myocardial Infarction: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Functional exercise capacity
研究概览
简要总结
This study aimed to investigate the effects of early-phase exercise-based supervised cardiac rehabilitation on functional exercise capacity, grip strength, fatigue, sleep quality, and health-related quality of life.
详细描述
Myocardial infarction (MI) is not only a severe form of coronary heart disease but also a leading cause of death and physical disability, particularly in the rapidly growing elderly population. Although percutaneous coronary interventions reduce mortality, ensuring the recovery and reintegration of discharged patients into society remains an unresolved issue. Cardiac rehabilitation (CR) is beneficial for patients with MI in terms of reducing cardiovascular mortality and hospital readmissions, managing cardiovascular risk factors, and improving aerobic capacity.
CR is a comprehensive intervention tailored to the individual needs of patients diagnosed with heart disease. It includes personalized exercise training, physical activity promotion, health education, cardiovascular risk management, and psychological support. Initial recommendations for CR were limited to low-risk patients following MI. However, over the past two decades, with the accumulation of evidence supporting the benefits of CR, current clinical guidelines now routinely recommend comprehensive CR for a broader range of cardiac diagnoses, including acute coronary syndrome and heart failure with reduced ejection fraction.
Until two decades ago, studies recommended starting CR in the early phase, defined as the second-week post-discharge. However, in the past decade, CR initiation with very low-intensity exercise activity as early as one week after MI onset has been reported as safe and effective. More recently, studies have shown the beneficial effects of terminating bed rest within 12-24 hours and initiating bedside activities. Phase I exercise-based CR has been shown to be effective in improving exercise capacity and preventing recurrent cardiac events. Nonetheless, concerns remain regarding early exercise-based CR due to exercise-induced ischemia after acute MI. While the effects of early rehabilitation initiated post-MI have been investigated in the literature, sufficient evidence has yet to be established.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically and medically stable patients with first MI
- •Prescribed cardiac rehabilitation by a cardiologist
- •Being between 30-65 years old
- •having ejection fraction (EF) of more than 20% (i.e. EF≥ 20%)
- •being volunteer to participate
排除标准
- •having coronary artery bypass graft surgery
- •Being diagnosed with chronic renal failure
- •Presence of unstable angina
- •Atrial fibrillation
- •Severe and symptomatic aortic stenosis
- •Presence of decompensated heart failure
- •Exercise-induced myocardial ischemia,
- •Pericardial disease,
- •Moderate-to-severe valve disease
- •COPD or asthma
- •BMI > 40 kg/m2
- •Orthopedic and neurological problems that prevent exercise
研究组 & 干预措施
Cardiac Rehabilitation Program
Patients who perform Phase I and Phase II Cardiac Rehabilitation Program
干预措施: Phase I and Phase II Cardiac Rehabilitation Program (Other)
Standard of care
The patients who received a usual care program
结局指标
主要结局
Functional exercise capacity
时间窗: 8 weeks
Functional exercise capacity assessment with 6-minute walk test distance as meters
次要结局
- SF-12 Health releated Quality of Life questionnaire(8 weeks)
- MacNew Heart Disease Health releated Quality of Life questionnaire(8 weeks)
- Fatigue(8 weeks)
- sleep quality(8 weeks)
- Grip strength(8 weeks)
研究者
Ozge Ocaker Aktan
Principal Investigator
Dokuz Eylul University
