Effects of Enhanced External Counterpulsation Combined With Cardiac Rehabilitation in Patients With Atrial Fibrillation

NCT07058987 | Not Yet Recruiting

• 2 other identifiers: LZUSH-AFCR-2025-001lanzhou university
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation (AF); Heart Failure (HF); Cardiac Rehabilitation

Keywords

Atrial Fibrillation; Cardiac Rehabilitation; Enhanced External Counterpulsation; Exercise Capacity

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 12 weeks after intervention

Secondary Outcomes (4)

• 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

Study Arms (2)

EECP + Cardiac Rehabilitation

EXPERIMENTAL

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.

Behavioral: Cardiac Rehabilitation Combined With EECP

Routine Medical Care

ACTIVE COMPARATOR

Participants will continue to receive standard pharmacologic management and routine clinical follow-up for atrial fibrillation without EECP or formal cardiac rehabilitation.

Other: Routine Medical Care

Interventions

Cardiac Rehabilitation Combined With EECP BEHAVIORAL

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.

Also known as: Enhanced External Counterpulsation, EECP, Cardiac Rehabilitation, CR, Lifestyle Modification, Exercise Training

EECP + Cardiac Rehabilitation

Routine Medical Care OTHER

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.

Also known as: Standard Care, Usual Care, Pharmacological Management

Routine Medical Care

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lanzhou University Second Hospital: lead

Study Sites (1)

Lanzhou University Second Hospital

Lanzhou, Gansu, 730030, China

Location

MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure

Interventions

Cardiac Rehabilitation; Exercise; Standard of Care

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Xiaowei Zhang PhD

  Lanzhou University Second Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaowei Zhang PhD

CONTACT

17701272944; yanxiwenny@foxmail.com

Yixin Xie

CONTACT

+86 18624069446; xieyixintaoyao@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lanzhou university second hospital

Model Details: Participants will be randomly assigned in a 1:1 ratio to either the intervention group (receiving EECP combined with cardiac rehabilitation) or the control group (receiving routine medical care). Each participant will remain in their assigned group throughout the study.

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 10, 2025
• Study Start: July 15, 2025
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: July 14, 2025

Record last verified: 2025-07

Locations

CN (1)