Effects of Exercise Training in Patients With Permanent Atrial Fibrillation
Effects of Exercise Training on Endothelial Function, Heart Rate Variability, Exercise Capacity, and Quality of Life in Patients With Permanent Atrial Fibrillation
Atrial fibrillation (AF) is a common arrhythmia. The proposed patholophysiological mechanisms of AF include abnormal electrical conduction in atrium and sympathovagal imbalance with increased vagal tone. Patients with AF have poor exercise capacity that may contribute to decreased atrial effective refractory period, and decreased cardiac output and heart rate reserve, and may result in poor quality of life. Poor endothelial function had been noted in patients with AF, associated with increased risks of cerebrovascular and cardiovascular disease. Exercise training has been noted to improve exercise capacity and quality of life in patients with AF only in some studies. Endothelial function can be improved by exercise training in patients with cardiovascular disease, but no report in patients with AF. Evidence of exercise training is still needed in patients with AF. The purpose of this study is to investigate the effect of exercise training on
- endothelial function
- heart rate variability
- exercise capacity
- quality of life.
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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Taipei、台湾
- National Taiwan University Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Permanent atrial fibrillation≥ 1 year aged 40-76 years
- Recurrence AF after ablation
- Under antiarrhythmia medication control
Exclusion Criteria:
- CAD or myocardial infrarction history
- NYHA≥ III-IV, or LVEF≤45%
- Mitral or aortic valve regurgitation ≥ Gr. II
- Mitral valve or aortic valve stenosis
- Pacemaker
- Cardioversion by ablation
- Pulmonary artery hypertension
- Any surgery in previous 3 months
- Any neurological disorders
- Cancer
- Severe musculoskeletal disorder
- Hyperthyroidism
- Premenopausal women
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Exercise training
Exercise group will undergo progressively aerobic exercise training with 40-85% maximal oxygen consumption for 40 minutes, 3 sessions per week for 12 weeks.
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Exercise group will undergo progressively aerobic exercise training with 40-85% maximal oxygen consumption for 40 minutes, 3 sessions per week for 12 weeks.
其他名称：
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无干预：control group
Control group conducted the usual care
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change of exercise capacity (after intervention)
大体时间：At baseline and 12 weeks after intervention
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To measure maximal oxygen consumption, maximal oxygen pulse, maximal heart rate and blood pressure, cumulated and peak workload by cycle ergometer with Vmax 229 system
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At baseline and 12 weeks after intervention
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change of heart rate variability (after intervention)
大体时间：At baseline and 12 weeks after intervention
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To record ECG by lead V1 with KENZ 170 on supine position for 1 hour
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At baseline and 12 weeks after intervention
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Change values of head up tilt test (after intervention)
大体时间：At baseline and 12 weeks after intervention
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Subjects were tilted up 60 degree on tilting table for 15 minutes to record the change of blood pressure and heart rate, and heart rate variability.
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At baseline and 12 weeks after intervention
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Change of endothelial function (after intervention)
大体时间：At baseline and 12 weeks after intervention
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To measure dependent-endothelial moulation by flow-mediated dilatation with Sonosite 180 portable ultrasound.
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At baseline and 12 weeks after intervention
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Change of quality of life (after intervention)
大体时间：At baseline and 12 weeks after intervention
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To measure quality of life by Short-form 36 and symptom checklist
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At baseline and 12 weeks after intervention
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合作者和调查者
调查人员
- 首席研究员：Ying-Tai Wu, phD、National Taiwan University Hospital
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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