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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
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.
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.
Vestre Viken Health Trust, Baerum Hospital
Bærums verk, Norway
RECRUITINGAtrial 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.
Time frame: Measured during the last 4 weeks (week 13-16) 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.
Time frame: Measured during the first 4 weeks (week 1-4) 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.
Time frame: 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.
Time frame: 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.
Time frame: Measured during the entire 16-week intervention period
Atrial fibrillation episode duration
Mean duration of atrial fibrillation episodes lasting ≥30sec
Time frame: Measured during the 16-week intervention period
Atrial fibrillation episodes
Number of atrial fibrillation episodes lasting ≥30sec, as measured by insertable cardiac monitor
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Measured during the 16-week intervention period
Days with atrial fibrillation
Days with at least one episode of atrial fibrillation lasting ≥30sec
Time frame: Measured during the 16-week intervention period
Days without atrial fibrillation
Days without atrial fibrillation episodes
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 16 weeks
Exercise capacity
Peak oxygen uptake (VO2peak)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Throughout study completion, an average of 22 weeks
Cardiovascular risk factors measured by blood pressure
Measure of blood pressure (mmHg)
Time frame: Measured at baseline and after the 16-week intervention period
Cardiovascular risk factors measured by blood lipids
Blood lipids (mmol/L)
Time frame: Measured at baseline and after the 16-week intervention period
Cardiovascular risk factors measured by weight
Weight (kg)
Time frame: 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)
Time frame: Measured at baseline and after the 16-week intervention period
Cardiovascular risk factors measured by smoking
Smoking (pack years)
Time frame: Measured at baseline and after the 16-week intervention period
Cardiovascular risk factors measured by alcohol units
Alcohol use (units)
Time frame: Measured at baseline and after the 16-week intervention period
Cardiovascular biomarkers - inflammation markers
Markers for inflammation markers; interleukines and hrCRP (mg/L)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: At peak exercise during cardiopulmonary exercise testing
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