Lanzhou University Second Hospital
Lanzhou, Gansu, 730030, China
NCT Number: NCT07058987
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.
Trial opening soon.
Get Notified40 year–80 year
All sexes
Interventional
Not applicable
Lanzhou, Gansu, 730030, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 names: Enhanced External Counterpulsation, EECP, Cardiac Rehabilitation, CR, Lifestyle Modification, Exercise Training
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.
Other names: Standard Care, Usual Care, Pharmacological Management
Time frame: Baseline and 12 weeks after intervention
LVEF will be assessed using transthoracic echocardiography to evaluate improvement in systolic cardiac function.
Time frame: Baseline and 12 weeks
6MWD will be measured to assess changes in functional exercise capacity.
Time frame: Throughout the 12-week intervention period
All adverse events related to EECP or cardiac rehabilitation will be recorded to assess safety and tolerability.
Time frame: Baseline and 12 weeks
Blood samples will be collected to assess changes in NT-proBNP, a biomarker of cardiac stress and heart failure severity.
Time frame: Baseline and 12 weeks
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.
Contact information is provided by the study sponsor or research team.
Xiaowei Zhang PhD
CONTACT
Yixin Xie
CONTACT
Lanzhou University Second Hospital
Other
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
Acronym: EECP AF CR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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