Effect of Aerobic Interval Training on Atrial Fibrillation Burden

Not Applicable

Not yet recruiting

• Conditions: Atrial Fibrillation; Cardiac Rehabilitation
• Interventions: Other: moderate-intensity interval training; Other: high-intensity interval training

• Registration Number: NCT06491329
• Lead Sponsor: Navy General Hospital, Beijing

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.

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-22
• Study First Submitted QC: 2024-06-30
• Study First Posted: 2024-07-09
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-02
• Study Start: 2024-08-15
• Primary Completion: 2027-07-15
• Study Completion: 2028-07-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 156

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
moderate-intensity interval training	moderate-intensity interval training	For non-permanent atrial fibrillation patients, a 12-week moderate-intensity interval training will be administered. The primary objective is to assess alterations in atrial fibrillation burden, with secondary endpoints encompassing changes in cardiorespiratory fitness, quality of life metrics, psychological profiling, atrial strain, ventricular diastolic function, as well as the incidence rates of exercise-related adverse events and adverse cardiovascular events.
High-intensity interval training	high-intensity interval training	For non-permanent atrial fibrillation patients, a 12-week high-intensity interval training will be administered. The primary objective is to assess alterations in atrial fibrillation burden, with secondary endpoints encompassing changes in cardiorespiratory fitness, quality of life metrics, psychological profiling, atrial strain, ventricular diastolic function, as well as the incidence rates of exercise-related adverse events and adverse cardiovascular events.

Primary Outcome Measures

Name	Time	Method
atrial fibrillation burden	14 weeks	The ratio of atrial fibrillation duration to total monitoring time

Secondary Outcome Measures

Name	Time	Method
Biochemical indicators-3	14 weeks	NT-proBNP
Severity of atrial fibrillation symptoms	14 weeks	Atrial Fibrillation Symptom EHRA Score
Atrial reservoir train	14 weeks	the difference of the strain value at the strain curve peak minus end-diastole
Biochemical indicators-2	14 weeks	lipids
Biochemical indicators-5	14 weeks	C-reactive protein
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).
ventricular diastolic function-2	14 weeks	lateral wall e' velocity
Biochemical indicators-1	14 weeks	blood glucose
Cardiorespiratory fitness	14 weeks	Peak oxygen consumption (VO2peak)
General quality of life assessment	14 weeks	SF-36 Quality of Life Questionnaire
Gneralized Anxiety Disorder Scale	14 weeks	GAD-7 Generalized Anxiety Disorder Scale
Biochemical indicators-4	14 weeks	interleukin
Prognostic indicators	14 weeks	MACE is defined as death, rehospitalization, cardiogenic shock, heart failure, new-onset malignant arrhythmias, stroke, and acute coronary syndrome
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
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

Trial Locations

Locations (1)

Sixth Medical Center of Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China