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.
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
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
Parallel
Cardiac Rehabilitation Combined With EECP
BehavioralThis intervention consists of a comprehensive cardiac rehabilitation program that includes individualized aerobic exercise training, health education, psychological support, and lifestyle counseling, combined with enhanced external counterpulsation (EECP) therapy administered according to standard cardiovascular protocols. The combined intervention is designed to improve cardiac function, exercise tolerance, and quality of life in patients with atrial fibrillation.
Routine Medical Care
Other interventionParticipants in the control group will receive standard medical treatment for atrial fibrillation as prescribed by their attending physicians, without enhanced external counterpulsation or structured cardiac rehabilitation. This may include pharmacological therapy, routine clinical monitoring, and general lifestyle advice.
Change in Left Ventricular Ejection Fraction (LVEF) from Baseline to Week 12
LVEF will be assessed using transthoracic echocardiography to evaluate improvement in systolic cardiac function.
Change in 6-Minute Walk Distance (6MWD)
6MWD will be measured to assess changes in functional exercise capacity.
Incidence of Adverse Events
All adverse events related to EECP or cardiac rehabilitation will be recorded to assess safety and tolerability.
Change in NT-proBNP Level
Blood samples will be collected to assess changes in NT-proBNP, a biomarker of cardiac stress and heart failure severity.
Change in Health-Related Quality of Life (HRQoL) Measured by SF-36 Total Score
The validated Chinese version of the Short-Form 36 Health Survey (SF-36; total score range 0 - 100, with higher scores indicating better health status) will be administered face-to-face by trained study nurses at baseline and Week 12. The primary metric will be the change in total SF-36 score computed using the standard scoring algorithm.
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