Effect of Aerobic Interval Training on Atrial Fibrillation Burden

NCT ID: NCT06491329

Last Updated: 2024-08-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-15
• Study Completion Date: 2028-07-30

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.

Conditions

Atrial Fibrillation; Cardiac Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

high-intensity interval training

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

moderate-intensity interval training

Intervention Type: OTHER

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.

Maintain previous exercise habits group

Not undergoing exercise rehabilitation, maintaining previous exercise habits

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Navy General Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

YU-TAO GUO, Doctor

Role: STUDY_CHAIR

Sixth Medical Center of Chinese PLA General Hospital

Locations

Sixth Medical Center of Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Hui Zhang

Role: CONTACT

zhanghuiay08@sina.com

8613683176151

References

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.

Reference Type: BACKGROUND

PMID: 36752479 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36315143 (View on PubMed)

Other Identifiers

HZKY-PJ-2024-29

Identifier Type: -

Identifier Source: org_study_id