Effect of Aerobic Interval Training on Atrial Fibrillation Burden
NCT Number: NCT06491329
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Atrial Fibrillation|Cardiac Rehabilitation
Interventions: OTHER: high-intensity interval training|OTHER: moderate-intensity interval training
Sponsor: Navy General Hospital, Beijing
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 156
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2028-07-30
Locations: Sixth Medical Center of Chinese PLA General Hospital, Beijing, Beijing, 100048, China

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.

Primary Outcome Measures: atrial fibrillation burden, The ratio of atrial fibrillation duration to total monitoring time, 14 weeks
Secondary Outcome Measures: Cardiorespiratory fitness, Peak oxygen consumption (VO2peak), 14 weeks|Severity of atrial fibrillation symptoms, Atrial Fibrillation Symptom EHRA Score, 14 weeks|General quality of life assessment, SF-36 Quality of Life Questionnaire, 14 weeks|Prognostic indicators, MACE is defined as death, rehospitalization, cardiogenic shock, heart failure, new-onset malignant arrhythmias, stroke, and acute coronary syndrome, 14 weeks|Incidence of Exercise-related adverse events (Safety indicators), 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)., 14 weeks|Atrial reservoir train, the difference of the strain value at the strain curve peak minus end-diastole, 14 weeks|Atrial conduit strain, the same value as atrial reservoir train, but with a negative sign, 14 weeks|Atrial contraction strain, the difference of the strain value at end diastole (by definition zero) minus the value at onset of atrial contraction, 14 weeks|ventricular diastolic function-1, Interventricular e' velocity, 14 weeks|ventricular diastolic function-2, lateral wall e' velocity, 14 weeks|Compliance assessment indicators, 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%., 14 weeks|Patient Health Questionnaires Scale, PHQ-9 Depression Self-Rating Scale, 14 weeks|Gneralized Anxiety Disorder Scale, GAD-7 Generalized Anxiety Disorder Scale, 14 weeks|Biochemical indicators-1, blood glucose, 14 weeks|Biochemical indicators-2, lipids, 14 weeks|Biochemical indicators-3, NT-proBNP, 14 weeks|Biochemical indicators-4, interleukin, 14 weeks|Biochemical indicators-5, C-reactive protein, 14 weeks