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| Name | Class |
|---|---|
| St. Olavs Hospital | OTHER |
| Baker Heart and Diabetes Institute | OTHER |
| Universitaire Ziekenhuizen KU Leuven | OTHER |
| University Hospital, Antwerp |
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Atrial fibrillation (AF) affects more than 43 million people worldwide, but specific exercise recommendations do not exist for this group of patients. Despite a lack of evidence, athletes are often advised to reduce exercise intensity (detraining) after being diagnosed with AF. This randomized controlled trial will be the first study that investigates effects of detraining in endurance athletes. Participants will be randomized to an intervention group that will be instructed to refrain from high intensity exercise, and a control group. The study aims to clarify whether detraining might reduce the burden of AF and has the potential to guide development of exercise guidelines for AF patients.
Atrial fibrillation (AF) affects more than 43 million people worldwide, but specific exercise recommendations do not exist for this group of patients. Despite a lack of evidence, athletes are often advised to reduce exercise intensity (detraining) after being diagnosed with AF. This randomized controlled trial will be the first study that investigates effects of detraining in endurance athletes. Participants will be included at Bærum Hospital, St.Olavs Hospital, Trondheim, Baker Institute, Melbourne, Leuven University Hospital, Antwerp University Hospital, AZ Jan Palfijn Gent and Jessa Hospital Hasselt, Belgium. In total 120 participants will be monitored with a chest-strap heart rate (HR) monitor and sportswatch (exercise intensity), and an Insertable Cardiac Monitor (ICM, AF burden). Participants will be randomized to an intervention group (n=60) that will be instructed to refrain from high intensity exercise (H) >75% of maximal HR (HRmax)) for a period of 16 Weeks, or a control group (n=60) that will be instructed to perform at least three weekly sessions of high intensity training (HR ≥85% of HRmax. The primary endpoint will be AF burden, as measured by continuous monitoring with ICMs and calculated as the cumulative duration of all AF episodes lasting ≥30sec divided by total duration of monitoring. The study aims to clarify whether detraining might reduce the burden of AF and has the potential to guide development of exercise guidelines for AF patients. The investigators will also study exercise-induced cardiac remodeling, aiming to improve the understanding of underlying pathophysiological mechanisms for AF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Detraining group | Experimental | Will be instructed to avoid high-intensity exercise corresponding to a heart rate >75% of maximum heart rate, and a total duration of exercise (hours/week) corresponding to >80% of the self-reported average weekly amount of exercise (hours/week) during the past six months, for a period of 16 week. |
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| Control group | Experimental | Will be instructed to perform at least three weekly sessions of high intensity exercise, corresponding to a HR ≥85% of maximum heart rate, and otherwise continue endurance exercise as usual. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Detraining group | Behavioral | Detraining is defined as exercise corresponding to a heart rate ≤75% of maximum heart rate and ≤80% of the self-reported average weekly amount of exercise (hours/week) during the past six months, for a period of 16 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Atrial fibrillation burden | Atrial fibrillation burden (time with atrial fibrillation) as measured by continuous monitoring with insertable cardiac monitor and calculated as the cumulative duration of all atrial fibrillation episodes lasting ≥30sec divided by total duration of monitoring and reported as percentages. | Measured during the last 4 weeks (week 13-16) of the 16-week intervention period |
| Measure | Description | Time Frame |
|---|---|---|
| Atrial fibrillation burden | Atrial fibrillation burden as measured by continuous monitoring with insertable cardiac monitor and calculated as the cumulative duration of all atrial fibrillation episodes lasting ≥30sec divided by total duration of monitoring. | Measured during the first 4 weeks (week 1-4) of the 16-week intervention period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marius Myrstad, MD;PhD | Contact | +47 92255945 | marium@vestreviken.no | |
| Marius Myrstad, MD, PhD | Contact | +47 92255945 | marium@vestreviken.no |
| Name | Affiliation | Role |
|---|---|---|
| Marius Myrstad, |MD, PhD | Vestre Viken Health trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vestre Viken Health Trust, Baerum Hospital | Recruiting | Bærums verk | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40764068 | Derived | Apelland T, Letnes JM, Janssens K, Claessen G, Tveit A, Sellevold AB, Mitchell A, Willems R, Onarheim S, Enger S, Kizilkilic SE, Miljoen H, Elliott A, Loennechen JP, La Gerche A, Myrstad M; NEXAF Investigators. Arrhythmia burden, symptoms and quality of life in female and male endurance athletes with paroxysmal atrial fibrillation: a multicentre cohort study in Norway, Australia and Belgium. BMJ Open. 2025 Aug 5;15(8):e100496. doi: 10.1136/bmjopen-2025-100496. | |
| 39762092 |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| OTHER |
| AZ Jan Palfijn Gent | OTHER |
| Jessa Hospital | OTHER |
Two-arm international multicenter open-label randomized (1:1) controlled trial with blinded end-point evaluation.
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Open label study and participants are not blinded to group allocation. Researchers and staff are unblinded during all procedures. AF burden will be adjudicated by a blinded endpoint committee and researchers will be blinded to group allocation when performing statistical analyses.
| Control group | Behavioral | At least three weekly sessions of high intensity exercise, corresponding to a heart rate ≥85% of maximum heart rate, and otherwise continue endurance exercise as usual. |
|
| Atrial fibrillation burden |
Atrial fibrillation burden as measured by continuous monitoring with insertable cardiac monitor and calculated as the cumulative duration of all atrial fibrillation episodes lasting ≥30sec divided by total duration of monitoring. |
| Measured during week 5-8 of the 16-week intervention period |
| Atrial fibrillation burden | Atrial fibrillation burden as measured by continuous monitoring with insertable cardiac monitor and calculated as the cumulative duration of all atrial fibrillation episodes lasting ≥30sec divided by total duration of monitoring. | Measured during week 9-12 of the 16-week intervention period |
| Cumulative atrial fibrillation burden | Atrial fibrillation burden as measured by continuous monitoring with insertable cardiac monitor and calculated as the cumulative duration of all atrial fibrillation episodes lasting ≥30sec divided by total duration of monitoring. | Measured during the entire 16-week intervention period |
| Atrial fibrillation episode duration | Mean duration of atrial fibrillation episodes lasting ≥30sec | Measured during the 16-week intervention period |
| Atrial fibrillation episodes | Number of atrial fibrillation episodes lasting ≥30sec, as measured by insertable cardiac monitor | Measured during the first 4 weeks (week 1-4) of the 16-week intervention period |
| Atrial fibrillation episodes | Number of atrial fibrillation episodes lasting ≥30sec, as measured by insertable cardiac monitor | Measured during week 5-8 of the 16-week intervention period |
| Atrial fibrillation episodes | Number of atrial fibrillation episodes lasting ≥30sec, as measured by insertable cardiac monitor | Measured during week 9-12 of the 16-week intervention period |
| Atrial fibrillation episodes | Number of atrial fibrillation episodes lasting ≥30sec, as measured by insertable cardiac monitor | Measured during the last 4 weeks (week 13-16) of the 16-week intervention period |
| Cumulative atrial fibrillation episodes | Number of atrial fibrillation episodes lasting ≥30sec, as measured by insertable cardiac monitor | Measured during the 16-week intervention period |
| Days with atrial fibrillation | Days with at least one episode of atrial fibrillation lasting ≥30sec | Measured during the 16-week intervention period |
| Days without atrial fibrillation | Days without atrial fibrillation episodes | Measured during the 16-week intervention period |
| Relative change in atrial fibrillation burden | Relative change in atrial fibrillation burden as measured by continuous monitoring with insertable cardiac monitor and calculated as the cumulative duration of all atrial fibrillation episodes lasting ≥30sec divided by total duration of monitoring | Measured during the 4-week baseline period prior to randomization and during the last 4 weeks of the 16-week intervention period |
| Relative change in atrial fibrillation burden | Relative change in atrial fibrillation burden as measured by continuous monitoring with insertable cardiac monitor and calculated as the cumulative duration of all atrial fibrillation episodes lasting ≥30sec divided by total duration of monitoring | Measured during the 4-week baseline period prior to randomization and during the first 4 weeks of the 16-week intervention period |
| Relative change in atrial fibrillation burden | Relative change in atrial fibrillation burden as measured by continuous monitoring with insertable cardiac monitor and calculated as the cumulative duration of all atrial fibrillation episodes lasting ≥30sec divided by total duration of monitoring | Measured during the 4-week baseline period prior to randomization and during the entire 16-week intervention period |
| Adherence to prescribed exercise | Adherence to prescribed exercise (>80% of exercise with ≥85% and ≤75% of maximum heart rate, respectively) | 16 weeks |
| Exercise capacity | Peak oxygen uptake (VO2peak) | Measured at the baseline study visit and at the final study visit after the 16-week intervention period |
| Atrial volumes | Right and left atrial volumes measured with echocardiography | Measured at the baseline study visit and at the final study visit after the 16-week intervention period |
| Ventricular volumes | Right and left ventricular volumes measured with echocardiography | Measured at the baseline study visit and at the final study visit after the 16-week intervention period |
| Atrial function | Left atrial function measured by strain with echocardiography | Measured at the baseline study visit and at the final study visit after the 16-week intervention period |
| Ventricular function | Right and left ventricular function measured by strain with echocardiography | Measured at the baseline study visit and at the final study visit after the 16-week intervention period |
| Systolic function | Left ventricular ejection fraction measured by strain with echocardiography | Measured at the baseline study visit and at the final study visit after the 16-week intervention period |
| Atrial fibrillation symptoms | Self-reported number of symptomatic atrial fibrillation episodes | Measured by questtionnaire at the baseline study visit and at the final study visit after the 16-week intervention period |
| Atrial Fibrillation Effect on QualiTy-of-life questionnaire | Measured with the Atrial Fibrillation Effect on QualiTy-of-life questionnaire (AFEQT). Minimum score 0, maximum score 100, higher values indicate better quality of life | Measured at the baseline study visit and at the final study visit after the 16-week intervention period |
| Atrial fibrillation hospitalizations | Number of unplanned hospitalizations due to atrial fibrillation cardioversion or ablation | Throughout study completion, an average of 22 weeks |
| Modified European Heart Rhythm Association Symptom Scale (mEHRA) symptom classification | Modified European Heart Rhythm Association Symptom Scale (mEHRA) questionnaire. The scale ranges from minimum 1 to maxiumum 4, a higher score indicates a worse symptom burden | Measured at the baseline study visit and at the final study visit after the 16-week intervention period |
| Number of ventricular arrhythmias | Ventricular arrhythmias lasting ≥12 ventricular complexes as measured by continuous monitoring with insertable cardiac monitor | Throughout study completion, an average of 22 weeks |
| Number of adverse events | Any unfavorable and unintended sign, symptom or illness that develops or worsens during the trial period will be reported as adverse events (AE). A serious adverse event (SAE) is defined as death, any life-threatening event or any inpatient hospitalisation | Throughout study completion, an average of 22 weeks |
| Cardiovascular risk factors measured by blood pressure | Measure of blood pressure (mmHg) | Measured at baseline and after the 16-week intervention period |
| Cardiovascular risk factors measured by blood lipids | Blood lipids (mmol/L) | Measured at baseline and after the 16-week intervention period |
| Cardiovascular risk factors measured by weight | Weight (kg) | Measured at baseline and after the 16-week intervention period |
| Cardiovascular risk factors measured by BMI | BMI (weight and height will be combined to report BMI in kg/m^2) | Measured at baseline and after the 16-week intervention period |
| Cardiovascular risk factors measured by smoking | Smoking (pack years) | Measured at baseline and after the 16-week intervention period |
| Cardiovascular risk factors measured by alcohol units | Alcohol use (units) | Measured at baseline and after the 16-week intervention period |
| Cardiovascular biomarkers - inflammation markers | Markers for inflammation markers; interleukines and hrCRP (mg/L) | Measured at baseline and after the 16-week intervention period |
| Cardiovascular biomarkers - markers for myocardial damage | Markers for myocardial damage, measured by troponin T (ng/L) and NT-ProBNP (ng/L) | Measured at baseline and after the 16-week intervention period |
| Immediate effects on arrhythmia burden of high-intensity exercise | Ahrrythmias measured with 24-hour electrocardiogram after peak exercise testing | 24 hours after after peak exercise testing |
| Immediate effects on biomarkers of exercise | Blood sampling at peak exercise for analyses of cardiac Troponins, NT-pro-BNP, interleukins, C-reactive protein | At peak exercise during cardiopulmonary exercise testing |
| Derived |
| Apelland T, Sellevold AB, Letnes JM, Onarheim S, Enger S, Tveit A, Delpire B, Claessen G, La Gerche A, Loennechen JP, Berge T, Myrstad M; NEXAF Investigators; NEXAF investigators. Cardiac arrhythmia assessment with patch electrocardiogram versus insertable cardiac monitor: a cohort study in endurance athletes with atrial fibrillation. BMJ Open. 2025 Jan 6;15(1):e093250. doi: 10.1136/bmjopen-2024-093250. |
| 37073174 | Derived | Apelland T, Janssens K, Loennechen JP, Claessen G, Sorensen E, Mitchell A, Sellevold AB, Enger S, Onarheim S, Letnes JM, Miljoen H, Tveit A, La Gerche A, Myrstad M; NEXAF investigators. Effects of training adaption in endurance athletes with atrial fibrillation: protocol for a multicentre randomised controlled trial. BMJ Open Sport Exerc Med. 2023 Apr 11;9(2):e001541. doi: 10.1136/bmjsem-2023-001541. eCollection 2023. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D008722 | Methods |