Effects of Enhanced External Counterpulsation Combined With Cardiac Rehabilitation in Patients With Atrial Fibrillation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cardiac Rehabilitation Combined With EECP, Routine Medical Care.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation (AF), Heart Failure (HF), Cardiac Rehabilitation. Basic parameters: 40 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
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.
Interventions
- Behavioral Cardiac Rehabilitation Combined With EECP
This 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. - Other Routine Medical Care
Participants 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.
Primary outcome measures
- Change in Left Ventricular Ejection Fraction (LVEF) from Baseline to Week 12 [Time frame: Baseline and 12 weeks after intervention]
Secondary outcome measures (4)
- Change in 6-Minute Walk Distance (6MWD) [Time frame: Baseline and 12 weeks]
- Incidence of Adverse Events [Time frame: Throughout the 12-week intervention period]
- Change in NT-proBNP Level [Time frame: Baseline and 12 weeks]
- Change in Health-Related Quality of Life (HRQoL) Measured by SF-36 Total Score [Time frame: Baseline and 12 weeks]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Lanzhou University Second Hospital — Lanzhou
Identifiers
NCT: NCT07058987 · LZUSH-AFCR-2025-001 · lanzhou university