Sixth Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, 100048, China
NCT Number: NCT06491329
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.
Trial opening soon.
Get Notified18 year–74 year
All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, 100048, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 14 weeks
The ratio of atrial fibrillation duration to total monitoring time
Time frame: 14 weeks
Peak oxygen consumption (VO2peak)
Time frame: 14 weeks
Atrial Fibrillation Symptom EHRA Score
Time frame: 14 weeks
SF-36 Quality of Life Questionnaire
Time frame: 14 weeks
MACE is defined as death, rehospitalization, cardiogenic shock, heart failure, new-onset malignant arrhythmias, stroke, and acute coronary syndrome
Time frame: 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).
Time frame: 14 weeks
the difference of the strain value at the strain curve peak minus end-diastole
Time frame: 14 weeks
the same value as atrial reservoir train, but with a negative sign
Time frame: 14 weeks
the difference of the strain value at end diastole (by definition zero) minus the value at onset of atrial contraction
Time frame: 14 weeks
Interventricular e' velocity
Time frame: 14 weeks
lateral wall e' velocity
Time frame: 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%.
Time frame: 14 weeks
PHQ-9 Depression Self-Rating Scale
Time frame: 14 weeks
GAD-7 Generalized Anxiety Disorder Scale
Time frame: 14 weeks
blood glucose
Time frame: 14 weeks
lipids
Time frame: 14 weeks
NT-proBNP
Time frame: 14 weeks
interleukin
Time frame: 14 weeks
C-reactive protein
Contact information is provided by the study sponsor or research team.
Navy General Hospital, Beijing
Other
Effect of Aerobic Interval Training on Atrial Fibrillation Burden:A Multicenter Randomized Controlled Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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