Atrial FibrillationNCT06491329
Effect of Aerobic Interval Training on Atrial Fibrillation Burden
A study testing high-intensity interval training and moderate-intensity interval training in people with Atrial Fibrillation and Cardiac Rehabilitation, run by Navy General Hospital, Beijing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Atrial Fibrillation, Cardiac Rehabilitation
- What is being tested?
- high-intensity interval training and moderate-intensity interval training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2024to 30 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 24Show fewer
- 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;
- Intracardiac thrombus;
- Pregnancy;
- Cognitive impairment preventing study cooperation;
- Severe anemia, infection, electrolyte disturbances, hyperthyroidism;
- Planned atrial fibrillation ablation during the study period;
- Post-implantation of pacemaker or ICD;
- Inability to use smart devices;
- Concurrent cancer or autoimmune or systemic inflammatory disease;
- Regular moderate-to-high intensity exercise habits (≥2 sessions of high-intensity endurance training per week or ≥3 sessions of moderate-intensity endurance training
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sixth Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, 100048
About this study
Official title: 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.
Read the 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
- Being tested
- high-intensity interval training, moderate-intensity interval training
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-intensity interval trainingOther
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 trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: moderate-intensity interval training |
| Maintain previous exercise habits group | No intervention | Not undergoing exercise rehabilitation, maintaining previous exercise habits |
What is being measured
The primary outcome is the main question the study is designed to answer.
atrial fibrillation burden
The ratio of atrial fibrillation duration to total monitoring time
Measured: 14 weeks
Secondary outcomes (18)
Cardiorespiratory fitness
Peak oxygen consumption (VO2peak)
Measured: 14 weeks
Severity of atrial fibrillation symptoms
Atrial Fibrillation Symptom EHRA Score
Measured: 14 weeks
General quality of life assessment
SF-36 Quality of Life Questionnaire
Measured: 14 weeks
Prognostic indicators
MACE is defined as death, rehospitalization, cardiogenic shock, heart failure, new-onset malignant arrhythmias, stroke, and acute coronary syndrome
Measured: 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).
Measured: 14 weeks
Atrial reservoir train
the difference of the strain value at the strain curve peak minus end-diastole
Measured: 14 weeks
Atrial conduit strain
the same value as atrial reservoir train, but with a negative sign
Measured: 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
Measured: 14 weeks
ventricular diastolic function-1
Interventricular e' velocity
Measured: 14 weeks
ventricular diastolic function-2
lateral wall e' velocity
Measured: 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%.
Measured: 14 weeks
Patient Health Questionnaires Scale
PHQ-9 Depression Self-Rating Scale
Measured: 14 weeks
Gneralized Anxiety Disorder Scale
GAD-7 Generalized Anxiety Disorder Scale
Measured: 14 weeks
Biochemical indicators-1
blood glucose
Measured: 14 weeks
Biochemical indicators-2
lipids
Measured: 14 weeks
Biochemical indicators-3
NT-proBNP
Measured: 14 weeks
Biochemical indicators-4
interleukin
Measured: 14 weeks
Biochemical indicators-5
C-reactive protein
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start15 Aug 2024 (estimated)
- Primary completion15 Jul 2027 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Navy General Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- YU-TAO GUO, Doctor, Study chair, Sixth Medical Center of Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491329
- Sponsor's protocol ID
- HZKY-PJ-2024-29
- Status last verified
- Jun 2024
- First submitted
- 22 Jun 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 36752479Reed 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.
PubMed 36315143
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aerobic Interval Training on Atrial Fibrillation Burden：A Multicenter Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06491329
- Acronym / sponsor ID
- HZKY-PJ-2024-29
- Conditions
- Atrial Fibrillation, Cardiac Rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Navy General Hospital, BeijingUniversity, hospital or other
- Study start
- 15 Aug 2024 (estimated)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 9 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-intensity interval training | Experimental | Other: high-intensity interval trainingFor 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. |
| moderate-intensity interval training | Experimental | Other: moderate-intensity interval trainingFor 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. |
| Maintain previous exercise habits group | No intervention | –Not undergoing exercise rehabilitation, maintaining previous exercise habits |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high-intensity interval traininghigh-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. | Other | High-intensity interval training |
| moderate-intensity interval training40-50 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. | Other | moderate-intensity interval training |
Primary outcome
atrial fibrillation burden
Time frame: 14 weeks
The ratio of atrial fibrillation duration to total monitoring time
18 secondary outcomes
Cardiorespiratory fitness
Time frame: 14 weeks
Severity of atrial fibrillation symptoms
Time frame: 14 weeks
General quality of life assessment
Time frame: 14 weeks
Prognostic indicators
Time frame: 14 weeks
Incidence of Exercise-related adverse events (Safety indicators)
Time frame: 14 weeks
Atrial reservoir train
Time frame: 14 weeks
Atrial conduit strain
Time frame: 14 weeks
Atrial contraction strain
Time frame: 14 weeks
ventricular diastolic function-1
Time frame: 14 weeks
ventricular diastolic function-2
Time frame: 14 weeks
Compliance assessment indicators
Time frame: 14 weeks
Patient Health Questionnaires Scale
Time frame: 14 weeks
Gneralized Anxiety Disorder Scale
Time frame: 14 weeks
Biochemical indicators-1
Time frame: 14 weeks
Biochemical indicators-2
Time frame: 14 weeks
Biochemical indicators-3
Time frame: 14 weeks
Biochemical indicators-4
Time frame: 14 weeks
Biochemical indicators-5
Time frame: 14 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Background: PubMed 36752479Elliott 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.
- Background: PubMed 36315143Reed 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.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
YU-TAO GUO, Doctor study chair
Sixth Medical Center of Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high-intensity interval training and moderate-intensity interval training in people with Atrial Fibrillation and Cardiac Rehabilitation, run by Navy General Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hui Zhang (8613683176151, zhanghuiay08@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
atrial fibrillation burden (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06491329, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024.