Status:
NOT_YET_RECRUITING
Effect of Aerobic Interval Training on Atrial Fibrillation Burden
Lead Sponsor:
Navy General Hospital, Beijing
Conditions:
Atrial Fibrillation
Cardiac Rehabilitation
Eligibility:
All Genders
18-74 years
Phase:
NA
Brief Summary
Atrial fibrillation is the most common arrhythmia, with an increasing incidence and prevalence, significantly increasing the risk of death, stroke, heart failure, cognitive impairment, and dementia, s...
Detailed Description
This study is a multicenter, prospective, randomized clinical trial. It aims to enroll a total of 156 patients with non-permanent atrial fibrillation. Participants will be randomly assigned to the HII...
Eligibility Criteria
Inclusion
- Age range: 18-74 years;
- Patients with non-permanent atrial fibrillation;
- Resting heart rate ≤110 beats/min;
- No history of receiving a formal exercise prescription within the past six months;
- Willing to participate in this study, provide written informed consent, and agree to comply with follow-up procedures.
Exclusion
- History of myocardial infarction, endocarditis/myocarditis/pericarditis, stroke (ischemic/hemorrhagic), pulmonary embolism, lower extremity venous thrombosis, or cardiac surgery within the past 6 months;
- Moderate to severe pulmonary arterial hypertension, moderate to severe valvular heart disease, hypertrophic cardiomyopathy, aortic stenosis/dilation/dissection/intramural hematoma, congenital heart disease;
- Heart failure (NYHA class III-IV) or acute exacerbation of heart failure within the past 3 months;
- Unstable angina or severe coronary artery disease without revascularization;
- Concurrent severe arrhythmias
- frequent multifocal premature ventricular contractions
- ventricular tachycardia, ventricular fibrillation
- high-degree or complete atrioventricular block
- ventricular asystole lasting more than 5 seconds
- Uncontrolled hypertension or hypotension;
- Severe renal or hepatic dysfunction
- Stage 5 chronic kidney disease, defined as glomerular filtration rate \<15 ml/(min•1.73 m2) or requiring dialysis;
- Patient with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than or equal to 5 times the upper limit of normal as defined by the center during screening;
- Hypoxemia or severe lung disease;
- Lower extremity arterial stenosis or musculoskeletal disease preventing exercise training;
- Intracardiac thrombus;
- Pregnancy;
- Cognitive impairment preventing study cooperation;
- Severe anemia, infection, electrolyte disturbances, hyperthyroidism;
- Planned atrial fibrillation ablation during the study period;
- Post-implantation of pacemaker or ICD;
- Inability to use smart devices;
- Concurrent cancer or autoimmune or systemic inflammatory disease;
- Regular moderate-to-high intensity exercise habits (≥2 sessions of high-intensity endurance training per week or ≥3 sessions of moderate-intensity endurance training
Key Trial Info
Start Date :
August 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2028
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT06491329
Start Date
August 15 2024
End Date
July 30 2028
Last Update
August 2 2024
Active Locations (1)
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1
Sixth Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100048