Atrial Fibrillation, Cardiac Rehabilitation
Conditions
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, 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.
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 HIIT group, MIIT group, and control group. The HIIT and MIIT groups will receive 12 weeks of high-intensity interval aerobic exercise training and moderate-intensity interval aerobic exercise training, respectively, while the control group will maintain their previous exercise habits.The study will compare the atrial fibrillation burden, cardiorespiratory fitness, quality of life scores, mental health scale scores, blood lipids, blood glucose levels, atrial strain, and ventricular diastolic function changes among patients in the different exercise intervention groups and the control group after 12 weeks. Additionally, the occurrence rates of exercise-related adverse events and cardiovascular adverse events during the follow-up period will be assessed to evaluate the effectiveness and safety of cardiac rehabilitation in the treatment of atrial fibrillation patients.
Interventions
OTHERhigh-intensity interval training
high-intensity interval training ： 40-50 minutes, patients engage in power cycling with intervals of high-intensity exercise at 75%-100% of VO2peak for 30s-1min, followed by 30s-1min of passive recovery, totaling 15-25 cycles.
OTHERmoderate-intensity interval training
40-50 minutes, involves power cycling with 8 minutes of moderate-intensity exercise at 40%-60% of VO2peak followed by 2 minutes of passive recovery, totaling 4 cycles.
Sponsors
Navy General Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
1. Age range: 18-74 years; 2. Patients with non-permanent atrial fibrillation; 3. Resting heart rate ≤110 beats/min; 4. No history of receiving a formal exercise prescription within the past six months; 5. Willing to participate in this study, provide written informed consent, and agree to comply with follow-up procedures.
Exclusion criteria
1. History of myocardial infarction, endocarditis/myocarditis/pericarditis, stroke (ischemic/hemorrhagic), pulmonary embolism, lower extremity venous thrombosis, or cardiac surgery within the past 6 months; 2. Moderate to severe pulmonary arterial hypertension, moderate to severe valvular heart disease, hypertrophic cardiomyopathy, aortic stenosis/dilation/dissection/intramural hematoma, congenital heart disease; 3. Heart failure (NYHA class III-IV) or acute exacerbation of heart failure within the past 3 months; 4. Unstable angina or severe coronary artery disease without revascularization; 5. 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 6. Uncontrolled hypertension or hypotension; 7. 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; 8. Hypoxemia or severe lung disease; 9. Lower extremity arterial stenosis or musculoskeletal disease preventing exercise training; 10. Intracardiac thrombus; 11. Pregnancy; 12. Cognitive impairment preventing study cooperation; 13. Severe anemia, infection, electrolyte disturbances, hyperthyroidism; 14. Planned atrial fibrillation ablation during the study period; 15. Post-implantation of pacemaker or ICD; 16. Inability to use smart devices; 17. Concurrent cancer or autoimmune or systemic inflammatory disease; 18. Regular moderate-to-high intensity exercise habits (≥2 sessions of high-intensity endurance training per week or ≥3 sessions of moderate-intensity endurance training
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| atrial fibrillation burden | 14 weeks | The ratio of atrial fibrillation duration to total monitoring time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of atrial fibrillation symptoms | 14 weeks | Atrial Fibrillation Symptom EHRA Score |
| General quality of life assessment | 14 weeks | SF-36 Quality of Life Questionnaire |
| Prognostic indicators | 14 weeks | MACE is defined as death, rehospitalization, cardiogenic shock, heart failure, new-onset malignant arrhythmias, stroke, and acute coronary syndrome |
| Incidence of Exercise-related adverse events (Safety indicators) | 14 weeks | Exercise-related adverse events are defined as falls during training, muscle ligament strains, headaches/dizziness, vomiting, angina, shortness of breath, syncope, hypotension, new-onset arrhythmias, acute heart failure, acute myocardial ischemia, hypoxemia (oxygen saturation \<88%), abnormal elevation or decrease in blood pressure (systolic blood pressure rising to ≥220 mmHg or falling by \>20 mmHg or diastolic blood pressure ≥120 mmHg). |
| Atrial reservoir train | 14 weeks | the difference of the strain value at the strain curve peak minus end-diastole |
| Atrial conduit strain | 14 weeks | the same value as atrial reservoir train, but with a negative sign |
| Atrial contraction strain | 14 weeks | the difference of the strain value at end diastole (by definition zero) minus the value at onset of atrial contraction |
| ventricular diastolic function-1 | 14 weeks | Interventricular e' velocity |
| Cardiorespiratory fitness | 14 weeks | Peak oxygen consumption (VO2peak) |
| Compliance assessment indicators | 14 weeks | Compliance of the intervention protocol, defined as the total number of actual training sessions completed divided by 36 sessions X 100%; Tolerance of the training protocol, defined as the number of actual training sessions completed according to the planned protocol, intensity, and duration divided by 36 sessions X 100%. |
| Patient Health Questionnaires Scale | 14 weeks | PHQ-9 Depression Self-Rating Scale |
| Gneralized Anxiety Disorder Scale | 14 weeks | GAD-7 Generalized Anxiety Disorder Scale |
| Biochemical indicators-1 | 14 weeks | blood glucose |
| Biochemical indicators-2 | 14 weeks | lipids |
| Biochemical indicators-3 | 14 weeks | NT-proBNP |
| Biochemical indicators-4 | 14 weeks | interleukin |
| Biochemical indicators-5 | 14 weeks | C-reactive protein |
| ventricular diastolic function-2 | 14 weeks | lateral wall e' velocity |
Countries
China
Contacts
Primary ContactHui Zhang
Outcome results
None listed