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临床试验/NCT03642886
NCT03642886Unknown不适用

The Use of Prescribed Detraining to Decrease Atrial Fibrillation Burden and Symptoms in Athletes.

Cardiology Research UBC1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2018年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
73
试验地点
1
主要终点
Symptomatic palpitations

研究概览

简要总结

This study will examine the effect of detraining as a clinical tool to prevent recurrence of lone paroxysmal atrial fibrillation (AF) and improve quality of life. Persons who engage in endurance activity with AF will be randomly assigned to undergo an 8-week period of detraining or encouraged to maintain their current level of exercise. Participants will receive a handheld device called AliveCor that can record an electrical tracing of the heart rhythm by pressing down with ones' thumbs. The amount of arrhythmia and symptoms will be recorded. The research team hypothesizes that among athletes with lone AF, an 8-week period of detraining will not affect atrial fibrillation recurrence or quality of life.

详细描述

Atrial fibrillation (AF) is the most common tachyarrhythmia amongst athletes. Atrial fibrillation is associated with poor subjective health among Masters athletes, and negatively interferes with athlete's sporting activities. The decrease in physical performance during AF episodes is attributed to the loss of atrial contribution to cardiac output related to irregular and decreased diastolic filling, and loss of sympathetic and parasympathetic control over heart rate.

There is a paucity of studies that examine the role of exercise in the treatment of atrial fibrillation among athletes. Detraining is the deliberate act of reducing volume of exercise to observe subsequent changes in cardiac indices over time or the partial or complete loss of training of induced anatomical, physiological and performance adaptions. Detraining is primarily employed as a diagnostic tool to help differentiate Athletes' heart from cardiac pathology. The role of detraining as a therapeutic modality is ill-defined and not well studied. There is a dearth of studies that examine the role of exercise in the treatment of atrial fibrillation among athletes. To date, only two observational studies (Furlanello and Hoogsteen) have suggested detraining as a potential treatment for AF among athletes. It is important to note the limitations of these studies: 1) observational study design 2) athletes were not systematically instructed to decrease exercise volume or 'detrain' 3) AF was not objectively assessed 4) pre and post measures of QOL were not recorded AF. Hoogsteen et al., surveyed 30 athletes about exercise and AF symptomatology at the time of diagnosis and 9 years later. At the time of the survey 30% of athletes noted a reduction in bouts of AF with a decrease in sporting activity. However, 43% of the athletes did not notice any relationship between reduction in activity and AF recurrence. This study was limited by the small sample size, selection bias due to symptomatic athletes responding, and AF recurrence based solely on subjective responses.

Detraining has been shown to decrease premature ventricular contractions (PVCs) and non-sustained ventricular tachycardia (NSVT) burden amongst elite athletes. After a 3-month detraining period, PVCs and NSVT decreased by eighty and ninety percent, respectively. The same group of athletes experienced a prolonged suppression of PVCs and NSVT at 1-year after retraining. While detraining is often suggested to athletes with AF, there is little evidence to support this practice. To date, only small case series and individual case reports exist.

This study aims to examine the effect of detraining as a clinical tool to prevent recurrence of lone paroxysmal AF (with no traditional AF risk factors and a structurally normal heart) and improve quality of life. Persons who engage in endurance activity with AF will be randomly assigned to undergo a 10-week period of detraining or encouraged to maintain their current level of exercise. Participants will receive a (1x 2.5 inch) handheld device called AliveCor that can record an electrical tracing of the heart rhythm by pressing down with ones' thumbs. The amount of arrhythmia and symptoms will be recorded. The research team hypothesizes that among athletes with lone AF, a 10-week period of detraining will not affect atrial fibrillation recurrence or quality of life.

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
Double (Investigator, Outcomes Assessor)

盲法说明

In adjudication of arrhythmia events the adjudicators would not know if the participants have been randomized to the detraining or control group

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age between 18 and 60
  • •Paroxysmal AF (eligible subjects must have had >1episode of AF within the last 12 months)
  • •Performs prolonged regular sessions of strenuous practice (≥6h/week with intensity greater than 60% of maximum heart rate for at least 6 months prior)
  • •Preserved ejection fraction (≥ 55%) with an absence of structural heart disease (hypertrophic cardiomyopathy, valvular heart disease, hypertensive heart disease)

排除标准

  • •BMI > 25 kg/m2
  • •Hypertension as per 2016 Canadian Hypertension Education Program Guidelines[52]
  • •Structural heart disease
  • •Obstructive sleep apnea
  • •Metabolic abnormalities (hyperthyroidism, pheochromocytoma)
  • •Pericarditis
  • •Coronary artery disease (defined as history of myocardial infarction, angina, q-waves on resting ECG, perfusion defect on nuclear scan, wall-motion abnormality on echocardiogram).
  • •Pre-excitation, Brugada syndrome, Long QT syndrome, arrhythmogenic cardiomyopathy or catecholaminergic polymorphic ventricular tachycardia
  • •Use of performance-enhancing agents
  • •Implanted cardiac pacemaker or defibrillator
  • •A concurrent period of involuntary deconditioning

研究组 & 干预措施

Continued Strenuous Exercise

No Intervention

Continued strenuous athletics (no reduction in training volume) - athletes will be asked to document their activity and be fitted with an activity monitor during the run-in period and intervention period

Prescribed Detraining

Experimental

Detraining period of 8-weeks which is defined as:

  1. a 75% decrease in the amount of exercise (from baseline)
  2. a 50% decrease in the intensity of exercise as measured in METS (from baseline)
  3. Mitchell Classification classes 1A, 2A, 2B of activity are permitted

干预措施: Prescribed Detraining (Behavioral)

结局指标

主要结局

Symptomatic palpitations

时间窗: 0-32 weeks

The number of patient reported symptomatic palpitations that correspond with documented atrial fibrillation (some participants may be experiencing AF but may not actually be symptomatic)

Ratio of atrial fibrillation (AF) episodes

时间窗: 0-32 weeks

Determine the effectiveness of systematic detraining on AF episodes (the number of AF AliveCor transmissions over the total number of daily transmissions (ECGaf/ECGtotal))

次要结局

  • Hospitalizations/emergency room visits(0-32 weeks)
  • General quality of life(Taken at 0, 8, and 32 weeks)
  • AF symptom severity(Taken at 0, 8, and 32 weeks)
  • Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) score(Taken at 0, 8, and 32 weeks)
  • DC cardioversions(0-32 weeks)
  • Percent referred for AF ablation(0-32 weeks)
  • Initiation of anti-arrhythmic drug therapy(0-32 weeks)

研究者

发起方
Cardiology Research UBC
申办方类型
Other
责任方
Principal Investigator
主要研究者

James McKinney

Research Director at SportsCardiologyBC

Cardiology Research UBC

研究点 (1)

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