A Prospective Randomized Controlled Study on the Effects of Enhanced External Counterpulsation Combined With Cardiac Rehabilitation on Cardiac Function and Exercise Capacity in Patients With Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in Left Ventricular Ejection Fraction (LVEF) from Baseline to Week 12
研究概览
简要总结
This is a prospective randomized controlled trial designed to evaluate the effectiveness of enhanced external counterpulsation (EECP) combined with cardiac rehabilitation in patients with atrial fibrillation. The study aims to assess whether this combined intervention can improve cardiac function and exercise capacity compared to standard care alone. Eligible participants will be randomly assigned to receive either the EECP plus cardiac rehabilitation program or routine treatment. Primary outcomes include changes in left ventricular ejection fraction (LVEF) and six-minute walking distance (6MWD). The study will be conducted at Lanzhou University Second Hospital.
详细描述
Atrial fibrillation (AF) is a common cardiac arrhythmia associated with impaired ventricular function, reduced exercise tolerance, and increased risk of cardiovascular events. While pharmacological treatments and catheter ablation are widely used, non-pharmacological interventions such as enhanced external counterpulsation (EECP) and cardiac rehabilitation (CR) may offer additional benefits for improving cardiac performance and quality of life. This prospective, single-center, randomized controlled trial aims to evaluate the effects of EECP combined with a structured cardiac rehabilitation program in patients with persistent or paroxysmal atrial fibrillation. A total of approximately 200 eligible participants will be randomized in a 1:1 ratio to receive either EECP plus cardiac rehabilitation (intervention group) or routine medical care (control group) for a defined treatment period. The cardiac rehabilitation program will include individualized exercise training, health education, risk factor management, and follow-up support. EECP will be performed according to standard protocols for cardiovascular patients. Primary outcome measures will include changes in left ventricular ejection fraction (LVEF) and six-minute walking distance (6MWD) from baseline to the end of the intervention. Secondary outcomes may include assessments of quality of life, symptoms, and biomarkers. Safety and feasibility will also be recorded. This study is expected to provide clinical evidence supporting the integration of EECP and cardiac rehabilitation as a non-invasive, multidimensional treatment approach in patients with atrial fibrillation.
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
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 40 and 80 years
- •Diagnosed with persistent or paroxysmal atrial fibrillation, confirmed by ECG or Holter
- •Stable medical condition and able to participate in cardiac rehabilitation and EECP therapy
- •Provided written informed consent
排除标准
- •Recent acute myocardial infarction, unstable angina, or decompensated heart failure within the past 4 weeks
- •Severe valvular heart disease or left ventricular ejection fraction <30%
- •Severe peripheral vascular disease or deep vein thrombosis
- •Severe pulmonary disease or active infection
- •History of bleeding disorders or contraindications to EECP
- •Cognitive impairment or psychiatric condition affecting study participation
- •Participation in another clinical trial within the past 3 months
研究组 & 干预措施
EECP + Cardiac Rehabilitation
Participants will receive enhanced external counterpulsation (EECP) plus a structured cardiac rehabilitation program that includes individualized aerobic exercise training, health education, psychological support and lifestyle counselling.
干预措施: Cardiac Rehabilitation Combined With EECP (Behavioral)
Routine Medical Care
Participants will continue to receive standard pharmacologic management and routine clinical follow-up for atrial fibrillation without EECP or formal cardiac rehabilitation.
干预措施: Routine Medical Care (Other)
结局指标
主要结局
Change in Left Ventricular Ejection Fraction (LVEF) from Baseline to Week 12
时间窗: Baseline and 12 weeks after intervention
LVEF will be assessed using transthoracic echocardiography to evaluate improvement in systolic cardiac function.
次要结局
- Incidence of Adverse Events(Throughout the 12-week intervention period)
- Change in NT-proBNP Level(Baseline and 12 weeks)
- Change in 6-Minute Walk Distance (6MWD)(Baseline and 12 weeks)
- Incidence of Adverse Events(Throughout the 12-week intervention period)
- Change in NT-proBNP Level(Baseline and 12 weeks)
- Change in Health-Related Quality of Life (HRQoL) Measured by SF-36 Total Score(Baseline and 12 weeks)
研究者
Xiaowei Zhang
lanzhou university second hospital
Lanzhou University Second Hospital