Exercise and Cardiac Measures in Dialysis Patients
Effects of Exercise Training on Non-invasive Cardiac Measures in Patients Undergoing Long-term Hemodialysis: A Randomized Controlled Trial
Background: The impact of the known non-invasive cardiac indices for identification of hemodialysis (HD) patients at high-risk for sudden cardiac death (SCD) has not been evaluated.
Patients: Fifty-nine HD patients were randomized into 2 groups. Thirty of them (group A-aged 54.6±8.9 years) participated in a supervised training program with stationary bicycles during their HD sessions (3/weekly) for 10 months, while the rest (group B-aged 53.2±6.1 years) remained untrained and were used as controls.
Study hypothesis: Exercise training will affect most of the non-invasive cardiac markers of SCD and the total score positively.
Method: At entry, as well as at the end of the study all subjects underwent a cardiopulmonary exercise testing (estimation of aerobic capacity-VO2peak), an echocardiographic study (LV ejection fraction -LVEF evaluation), an ambulatory 24-hour Holter monitoring for cardiac autonomic nervous system activity evaluation by time- and frequency- domain heart rate variability (HRV) calculation (measurement of SDNN, mean RR and low to high frequency ratio-LF/HF), a signal-averaged ECG (late potentials-LP documentation) and a submaximal exercise test for microvolt-T-wave alternans (TWA) detection.
研究概览
详细说明
The identification of patients on hemodialysis (HD) at increased cardiac risk with powerful screening tests and the reduction of factors, which increase the probability of malignant arrhythmias are important for primary prevention of sudden cardiac death (SCD).
Study Design: randomized and controlled clinical trial. Setting & Participants: Fifty-nine HD patients were randomized into exercise training group (group A-30 patients) and controls (group B-29 patients).
Intervention: Group A participated in a 10-month supervised exercise training program during the HD sessions (3/weekly).
Outcomes: The effects of exercise on the score of the non-invasive cardiac markers for SCD risk stratification and on the occurrence of each variable separately. Statistical analysis included a two-group comparison of change scores and an analysis of covariance adjusting for baseline.
Measurements: At entry and the end of the study, in all participants aerobic capacity (VO2peak) and left ventricular ejection fraction (LVEF) were estimated, late potentials and T-wave alternans were detected and heart rate variability was calculated. Specifically, from the 24-h Holter monitoring the standard deviation of all the normal R-R intervals (SDNN), the mean R-R intervals (mean RR), the low (LF) and high (HF) frequency components of the autoregressive power spectrum of the NN intervals and their ratio (LF/HF) were recorded.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Thessaloniki、希腊、546 35
- Laboratory of Sports Medicine
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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:
- on HD for at least 6 months
- in sinus rhythm
- able to reach a sufficient workload during ergometry
Exclusion Criteria:
- with bundle branch block
- unstable hypertension
- diabetes mellitus
- severe congestive heart failure
- recent myocardial infarction
- unstable angina
学习计划
研究是如何设计的?
设计细节
- 主要用途:放映
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:exercise training
10-month exercise training program
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10-month exercise training program during hemodialysis sessions
其他名称:
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无干预:controls
usual care sedentary lifestyle
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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The composite risk score
大体时间:at entry and after 10 months
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at entry and after 10 months
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次要结果测量
结果测量 |
大体时间 |
|---|---|
|
aerobic capacity (VO2peak)
大体时间:At entry and after 10 months
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At entry and after 10 months
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Left ventricular ejection fraction (EF)- echocardiography
大体时间:At entry and after 10 months
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At entry and after 10 months
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standard deviation of normal R-R intervals- SDNN (holter monitoring)
大体时间:At entry and after 10 months
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At entry and after 10 months
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positive T-wave alternans and Late potentials
大体时间:At entry and after 10 months
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At entry and after 10 months
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合作者和调查者
调查人员
- 首席研究员:Evangelia J Kouidi, Associate Pr、Aristotle University of Thessaloniki, Greece
出版物和有用的链接
一般刊物
- Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.
- Kouidi EJ, Grekas DM, Deligiannis AP. Effects of exercise training on noninvasive cardiac measures in patients undergoing long-term hemodialysis: a randomized controlled trial. Am J Kidney Dis. 2009 Sep;54(3):511-21. doi: 10.1053/j.ajkd.2009.03.009. Epub 2009 Jul 30.
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 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- RenalRehab
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