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Exercise and Cardiac Measures in Dialysis Patients

2017年10月25日 更新者:Evangelia Kouidi、Aristotle University Of Thessaloniki

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

地位

完全的

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

介入性

注册 (实际的)

63

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Thessaloniki、希腊、546 35
        • Laboratory of Sports Medicine

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 70年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
实验性的:exercise training
10-month exercise training program
10-month exercise training program during hemodialysis sessions
其他名称:
  • B组
  • A组
无干预:controls
usual care sedentary lifestyle

研究衡量的是什么?

主要结果指标

结果测量
大体时间
The composite risk score
大体时间:at entry and after 10 months
at entry and after 10 months

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
At entry and after 10 months
Left ventricular ejection fraction (EF)- echocardiography
大体时间:At entry and after 10 months
At entry and after 10 months
standard deviation of normal R-R intervals- SDNN (holter monitoring)
大体时间:At entry and after 10 months
At entry and after 10 months
positive T-wave alternans and Late potentials
大体时间:At entry and after 10 months
At entry and after 10 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

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

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2007年8月1日

初级完成 (实际的)

2008年5月1日

研究完成 (实际的)

2008年6月1日

研究注册日期

首次提交

2009年4月9日

首先提交符合 QC 标准的

2009年7月22日

首次发布 (估计)

2009年7月23日

研究记录更新

最后更新发布 (实际的)

2017年10月26日

上次提交的符合 QC 标准的更新

2017年10月25日

最后验证

2017年10月1日

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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