Effect of Aerobic Interval Training on Atrial Fibrillation Burden

NCT06491329 | Not Yet Recruiting

• 1 other identifier: HZKY-PJ-2024-29
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Cardiac Rehabilitation

Outcome Measures

Primary Outcomes (1)

• atrial fibrillation burden

  The ratio of atrial fibrillation duration to total monitoring time

  14 weeks

Secondary Outcomes (18)

• Cardiorespiratory fitness

  14 weeks

• Severity of atrial fibrillation symptoms

  14 weeks

• General quality of life assessment

  14 weeks

• Prognostic indicators

  14 weeks

• Incidence of Exercise-related adverse events (Safety indicators)

  14 weeks

Study Arms (3)

High-intensity interval training

EXPERIMENTAL

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

moderate-intensity interval training

EXPERIMENTAL

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

Maintain previous exercise habits group

NO INTERVENTION

Not undergoing exercise rehabilitation, maintaining previous exercise habits

Interventions

high-intensity interval training 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.

High-intensity interval training

moderate-intensity interval training 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.

moderate-intensity interval training

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range: 18-74 years;
• Patients with non-permanent atrial fibrillation;
• Resting heart rate ≤110 beats/min;
• No history of receiving a formal exercise prescription within the past six months;
• Willing to participate in this study, provide written informed consent, and agree to comply with follow-up procedures.

You may not qualify if:

• History of myocardial infarction, endocarditis/myocarditis/pericarditis, stroke (ischemic/hemorrhagic), pulmonary embolism, lower extremity venous thrombosis, or cardiac surgery within the past 6 months;
• Moderate to severe pulmonary arterial hypertension, moderate to severe valvular heart disease, hypertrophic cardiomyopathy, aortic stenosis/dilation/dissection/intramural hematoma, congenital heart disease;
• Heart failure (NYHA class III-IV) or acute exacerbation of heart failure within the past 3 months;
• Unstable angina or severe coronary artery disease without revascularization;
• 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
• Uncontrolled hypertension or hypotension;
• 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;
• Hypoxemia or severe lung disease;
• Lower extremity arterial stenosis or musculoskeletal disease preventing exercise training;

Sponsors & Collaborators

• Navy General Hospital, Beijing: lead

Study Sites (1)

Sixth Medical Center of Chinese PLA General Hospital

Beijing, Beijing Municipality, 100048, China

Location

Related Publications (2)

• 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.

  PMID: 36752479 BACKGROUND

• 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.

  PMID: 36315143 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• YU-TAO GUO, Doctor

  Sixth Medical Center of Chinese PLA General Hospital

  STUDY CHAIR

Central Study Contacts

Hui Zhang

CONTACT

8613683176151; zhanghuiay08@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2024
• First Posted: July 9, 2024
• Study Start: August 15, 2024
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): July 30, 2028
• Last Updated: August 2, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)