NCT06491329Not yet recruiting
Effect of Aerobic Interval Training on Atrial Fibrillation Burden
Effect of Aerobic Interval Training on Atrial Fibrillation Burden：A Multicenter Randomized Controlled Study
Source: ClinicalTrials.gov · Last updated 2 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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, severely impacting the quality of life for patients and burdening society and healthcare systems. In recent years, exercise-based cardiac rehabilitation has gradually become a new approach for the treatment of patients with heart disease. The main research topics include: 1. Changes in atrial fibrillation burden in non-permanent atrial fibrillation patients after 12 weeks of HIIT(high-intensity interval training ) or MIIT (moderate-intensity interval training). 2. Changes in cardiorespiratory fitness, quality of life scores, mental health assessment scores, atrial strain, and left ventricular diastolic function in non-permanent atrial fibrillation patients after 12 weeks of aerobic interval training, along with follow-up on the occurrence of exercise-related adverse events and adverse cardiovascular events during the study period.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 156 (estimated)
- First submitted
- 22 Jun 2024
- Start date
- 15 Aug 2024
- Primary completion date
- 15 Jul 2027
- Lead sponsor
- Navy General Hospital, Beijing
- Diseases
- Atrial fibrillation
- NCT number
- NCT06491329
What you commit to
- Study type: Interventional
- Planned participants: 156
- From 15 Aug 2024 to the primary completion date, 15 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Concurrent cancer or autoimmune or systemic inflammatory disease;
Other illness
- 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;
- Uncontrolled hypertension or hypotension;
- Hypoxemia or severe lung disease;
- Lower extremity arterial stenosis or musculoskeletal disease preventing exercise training;
- Cognitive impairment preventing study cooperation;
- Severe anemia, infection, electrolyte disturbances, hyperthyroidism;
Lab values
- 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;
Other
- Intracardiac thrombus;
- Pregnancy;
- Planned atrial fibrillation ablation during the study period;
- Post-implantation of pacemaker or ICD;
- Inability to use smart devices;
- Regular moderate-to-high intensity exercise habits (≥2 sessions of high-intensity endurance training per week or ≥3 sessions of moderate-intensity endurance training
Who the study is looking for
- 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.
Age in the registry: 18 years to 74 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sixth Medical Center of Chinese PLA General Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.