此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

The Effect of Exercise on Peripheral Blood Gene Expression in Angina

A Randomised Trial of the Effect of Exercise on Peripheral Blood Gene Expression in Patients With Stable Angina

Regular exercise is known to produce significant health benefits and to reduce the risk of heart diseases, although how this benefit occurs is not well understood. White blood cells are known to be involved in triggering heart attacks, and which genes are switched on or off in white blood cells determines whether they have beneficial or harmful effects. Previous studies, and studies ongoing in our group, have demonstrated measurement of peripheral blood gene expression (which reflects white blood cell gene expression) is able to distinguish between patients with and without coronary artery disease, or patients who are able to develop good compared with poor coronary collateral arteries. Therefore, the gene expression signature in peripheral blood may provide novel diagnostic or prognostic information, and insight into the pathogenesis of heart disease.

We therefore hypothesise that exercise alters peripheral blood gene expression in patients with coronary artery disease and angina. This will identify possible ways that exercise improves angina and reduces the risk of heart disease.

研究概览

地位

完全的

条件

研究类型

介入性

注册 (实际的)

60

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

    • South Yorkshire
      • Sheffield、South Yorkshire、英国、S5 7AU
        • NIHR Cardiovascular Biomedical Research Unit

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

30年 至 80年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Class I to III angina pectoris (classified according to the Canadian Cardiovascular Society [CCS])with documented myocardial ischemia or coronary artery disease on angiography
  • Ability to read and speak English to a level allowing satisfactory completion of written questionnaires and to understand instruction during the exercise programme.

Exclusion Criteria:

  • Acute coronary syndromes or recent myocardial infarction (<2 months)
  • Left main coronary artery stenosis >25% or high-grade proximal left anterior descending artery stenosis
  • Known reduced left ventricular function (ejection fraction <40%)
  • Significant valvular heart disease
  • Insulin-dependent diabetes mellitus
  • Occupational, orthopedic, and other conditions that preclude regular exercise
  • Patients whose ECG prevents interpretation of an exercise test (LBBB, RBBB, pacemaker implantation).
  • Patients who already perform greater than 30min continuous exercise three times weekly (self-reported).

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:基础科学
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:12 week exercise training
randomised to 12 weeks of exercise training up to three times weekly. Training will be interval training with active recovery, with 3 min intervals conducted 10bpm below angina threshold.
无干预:Conventional Care

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Peripheral blood gene expression
大体时间:baseline
baseline
Peripheral blood gene expression
大体时间:6wks after starting 12week exercise training (or conventional care)
6wks after starting 12week exercise training (or conventional care)
peripheral blood gene expression
大体时间:12 weeks after exercise training (or conventional care)
12 weeks after exercise training (or conventional care)
Peripheral blood gene expression
大体时间:24 weeks after starting 12 weeks exercise training programme
24 weeks after starting 12 weeks exercise training programme

次要结果测量

结果测量
大体时间
Angina status
大体时间:baseline
baseline
Angina status
大体时间:6wks after starting 12 week exercise programme (or conventional care)
6wks after starting 12 week exercise programme (or conventional care)
Angina status
大体时间:12wks after starting 12 week exercise programme (or conventional care)
12wks after starting 12 week exercise programme (or conventional care)
Angina Status
大体时间:24wks after starting 12 week exercise programme (or conventional care)
24wks after starting 12 week exercise programme (or conventional care)
Anxiety Score
大体时间:baseline
baseline
Anxiety Score
大体时间:6wks after starting 12 week exercise programme (or conventional care)
6wks after starting 12 week exercise programme (or conventional care)
Anxiety Score
大体时间:12wks after starting 12 week exercise programme (or conventional care)
12wks after starting 12 week exercise programme (or conventional care)
Anxiety Score
大体时间:24wks after starting 12 week exercise programme (or conventional care)
24wks after starting 12 week exercise programme (or conventional care)
Depression Score
大体时间:6wks after starting 12 week exercise programme (or conventional care)
6wks after starting 12 week exercise programme (or conventional care)
Depression Score
大体时间:baseline
baseline
Depression Score
大体时间:12wks after starting 12 week exercise programme (or conventional care)
12wks after starting 12 week exercise programme (or conventional care)
Depression Score
大体时间:24wks after starting 12 week exercise programme (or conventional care)
24wks after starting 12 week exercise programme (or conventional care)

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。

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

2010年11月1日

初级完成 (实际的)

2014年5月1日

研究完成 (实际的)

2014年5月1日

研究注册日期

首次提交

2010年6月18日

首先提交符合 QC 标准的

2010年6月18日

首次发布 (估计)

2010年6月22日

研究记录更新

最后更新发布 (估计)

2016年4月14日

上次提交的符合 QC 标准的更新

2016年4月13日

最后验证

2016年4月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

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.

Structured exercise training的临床试验

3
订阅