Clinical trial NCT06491329: Effect of Aerobic Interval Training on Atrial Fibrillation Burden
Official title: Effect of Aerobic Interval Training on Atrial Fibrillation Burden：A Multicenter Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Cardiac Rehabilitation
Lead sponsor: Navy General Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: atrial fibrillation burden
timeFrame: 14 weeks
Secondary outcomes:
measure: Cardiorespiratory fitness
timeFrame: 14 weeks
measure: Severity of atrial fibrillation symptoms
timeFrame: 14 weeks
measure: General quality of life assessment
timeFrame: 14 weeks
measure: Prognostic indicators
timeFrame: 14 weeks
measure: Incidence of Exercise-related adverse events (Safety indicators)
timeFrame: 14 weeks
measure: Atrial reservoir train
timeFrame: 14 weeks
measure: Atrial conduit strain
timeFrame: 14 weeks
measure: Atrial contraction strain
timeFrame: 14 weeks
measure: ventricular diastolic function-1
timeFrame: 14 weeks
measure: ventricular diastolic function-2
timeFrame: 14 weeks
measure: Compliance assessment indicators
timeFrame: 14 weeks
measure: Patient Health Questionnaires Scale
timeFrame: 14 weeks
measure: Gneralized Anxiety Disorder Scale
timeFrame: 14 weeks
measure: Biochemical indicators-1
timeFrame: 14 weeks
measure: Biochemical indicators-2
timeFrame: 14 weeks
measure: Biochemical indicators-3
timeFrame: 14 weeks
measure: Biochemical indicators-4
timeFrame: 14 weeks
measure: Biochemical indicators-5
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Sixth Medical Center of Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Sixth Medical Center of Chinese PLA General Hospital
name: YU-TAO GUO, Doctor
role: STUDY_CHAIR
References:
citation: Elliott AD, Verdicchio CV, Mahajan R, Middeldorp ME, Gallagher C, Mishima RS, Hendriks JML, Pathak RK, Thomas G, Lau DH, Sanders P. An Exercise and Physical Activity Program in Patients With Atrial Fibrillation: The ACTIVE-AF Randomized Controlled Trial. JACC Clin Electrophysiol. 2023 Apr;9(4):455-465. doi: 10.1016/j.jacep.2022.12.002. Epub 2023 Jan 18.
citation: Reed JL, Terada T, Vidal-Almela S, Tulloch HE, Mistura M, Birnie DH, Wells GA, Nair GM, Hans H, Way KL, Chirico D, O'Neill CD, Pipe AL. Effect of High-Intensity Interval Training in Patients With Atrial Fibrillation: A Randomized Clinical Trial. JAMA Netw Open. 2022 Oct 3;5(10):e2239380. doi: 10.1001/jamanetworkopen.2022.39380.