Effects of Detraining in Endurance Athletes With Atrial Fibrillation (NEXAF Detraining)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Atrial fibrillation burden
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Age ≥ 18 years
- •Diagnosed with paroxysmal atrial fibrillation (verified by electrocardiogram)
- •Report >5 (running, rowing) or >8 (cycling, cross-country skiing), weekly hours, respectively, of endurance sport
- •At least two anamnestic (self-reported) episodes of atrial fibrillation, of which one during the last six months
- •Use a smartphone and agree to connect their sportswatch with a web-based platform for monitoring of exercise
排除标准
- •Permanent atrial fibrillation
- •Cardiac conditions (including valvular heart disease of moderate or greater severity, symptomatic ischemic heart disease)
- •Left ventricular ejection fraction <45%
- •Hypertension (>140/90)
- •Diabetes mellitus
- •Hyperthyroidism
- •Smoking during the last 5 years
- •Alcohol intake >20 alcohol units/week
- •Use of illegal or performance enhancing drugs
- •Body mass index >30kg/m2
- •Injuries preventing physical exercise
- •Pregnancy
- •Participation in conflicting intervention research studies
- •Planned atrial fibrillation ablation within the next six months
- •The individual refuses to have an insertable cardiac monitor, blood samples taken or be part of the detraining group
结局指标
主要结局
Atrial fibrillation burden
时间窗: Measured during the last 4 weeks (week 13-16) of the 16-week intervention period
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.
次要结局
- Atrial fibrillation episodes(Measured during the last 4 weeks (week 13-16) of the 16-week intervention period)
- Atrial volumes(Measured at the baseline study visit and at the final study visit after the 16-week intervention period)
- Atrial function(Measured at the baseline study visit and at the final study visit after the 16-week intervention period)
- Exercise capacity(Measured at the baseline study visit and at the final study visit after the 16-week intervention period)
- Systolic function(Measured at the baseline study visit and at the final study visit after the 16-week intervention period)
- Atrial fibrillation burden(Measured during week 9-12 of the 16-week intervention period)
- Cumulative atrial fibrillation episodes(Measured during the 16-week intervention period)
- Days with atrial fibrillation(Measured during the 16-week intervention period)
- Days without atrial fibrillation(Measured during the 16-week intervention period)
- Relative change in atrial fibrillation burden(Measured during the 4-week baseline period prior to randomization and during the entire 16-week intervention period)
- Number of ventricular arrhythmias(Throughout study completion, an average of 22 weeks)
- Cardiovascular risk factors measured by alcohol units(Measured at baseline and after the 16-week intervention period)
- Cumulative atrial fibrillation burden(Measured during the entire 16-week intervention period)
- Atrial fibrillation episode duration(Measured during the 16-week intervention period)
- Atrial fibrillation symptoms(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 at the baseline study visit and at the final study visit after the 16-week intervention period)
- Atrial fibrillation hospitalizations(Throughout study completion, an average of 22 weeks)
- Modified European Heart Rhythm Association Symptom Scale (mEHRA) symptom classification(Measured at the baseline study visit and at the final study visit after the 16-week intervention period)
- Cardiovascular biomarkers - markers for myocardial damage(Measured at baseline and after the 16-week intervention period)
- Immediate effects on arrhythmia burden of high-intensity exercise(24 hours after after peak exercise testing)
- Adherence to prescribed exercise(16 weeks)
- Ventricular volumes(Measured at the baseline study visit and at the final study visit after the 16-week intervention period)
- Ventricular function(Measured at the baseline study visit and at the final study visit after the 16-week intervention period)
- Cardiovascular risk factors measured by BMI(Measured at baseline and after the 16-week intervention period)
- Cardiovascular risk factors measured by smoking(Measured at baseline and after the 16-week intervention period)
- Immediate effects on biomarkers of exercise(At peak exercise during cardiopulmonary exercise testing)
- Number of adverse events(Throughout study completion, an average of 22 weeks)
- Cardiovascular risk factors measured by blood pressure(Measured at baseline and after the 16-week intervention period)
- Cardiovascular risk factors measured by weight(Measured at baseline and after the 16-week intervention period)
- Cardiovascular risk factors measured by blood lipids(Measured at baseline and after the 16-week intervention period)
- Cardiovascular biomarkers - inflammation markers(Measured at baseline and after the 16-week intervention period)