Effect of Aerobic Interval Training on Atrial Fibrillation Burden

Effect of Aerobic Interval Training on Atrial Fibrillation Burden：A Multicenter Randomized Controlled Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation; Cardiac Rehabilitation
• Intervention / Treatment: Other: high-intensity interval training; Other: moderate-intensity interval training

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 Type: Interventional
• Enrollment (Estimated): 156
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hui Zhang; Phone Number: 8613683176151; Email: zhanghuiay08@sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100048
      • Sixth Medical Center of Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: high-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.
Experimental: 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.	Other: moderate-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.
No Intervention: Maintain previous exercise habits group; Not undergoing exercise rehabilitation, maintaining previous exercise habits

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
atrial fibrillation burden	The ratio of atrial fibrillation duration to total monitoring time	14 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Navy General Hospital, Beijing
• Investigators: Study Chair: YU-TAO GUO, Doctor, Sixth Medical Center of Chinese PLA General Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): August 15, 2024
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): July 30, 2028

Study Registration Dates

• First Submitted: June 22, 2024
• First Submitted That Met QC Criteria: June 30, 2024
• First Posted (Actual): July 9, 2024

Study Record Updates

• Last Update Posted (Actual): August 2, 2024
• Last Update Submitted That Met QC Criteria: August 1, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: HZKY-PJ-2024-29

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No