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Aerobic Exercise Training & the Autonomic System In Patients After Myocardial Infarction or Stroke

2005年11月30日 更新者:Hadassah Medical Organization

The Effect of Aerobic Exercise Training On the Function of the Autonomic System In Patients That Have Suffered Myocardial Infarction or Stroke

The purpose of this study is to examine the effect of Aerobic Physical Activity on the function of the Autonomic System in patients after Myocardial Infarction or Stroke.

A secondary objective is to examine whether it is possible to predict which of the patients will most benefit from physical activity (exercise training), taking into account, genetic factors such as Polymorphism of ACE (Angiotensin Converting Enzyme)

研究概览

详细说明

Imbalance in autonomic cardiovascular function has been shown to increase the risk of ventricular arrhythmias and sudden death in patients with coronary artery disease (CAD), after myocardial infarction and after stroke. Heart rate variability (HRV) reflects the autonomic tone of the heart. Under these conditions there is an increased sympathetic adrenergic tone and reduced parasympathetic activity. The effect of aerobic rehabilitation on the Sympathetic-parasympathetic control has been examined. exercise training alters sympatho-vagal control of heart rate variability (HRV) towards parasympathetic dominance in patients after acute myocardial infarction (MI) and in diabetic patients. To our knowledge, in post-stroke patients this issue hasn't been investigated.

It is known that different people react differently to physical training. There is a difference of opinion in literature concerning the function of Genetic parameters, such as the Polymorphism of ACE (Angiotensin Converting Enzyme), in hemodynamic Reactions following Physical Activity and whether there is a connection between Polymorphism and physical performance..

Objectives To examine the effect of Aerobic Physical Activity on the function of the Autonomic System in patients after Myocardial Infarction or Stroke.

A secondary objective is to examine whether it is possible to predict which of the patients will most benefit from physical activity (exercise training), taking into account, genetic factors such as Polymorphism of ACE (Angiotensin Converting Enzyme)

Research Population The research subjects include a) patients after Myocardial Infarction between the ages 20 - 80 , who underwent percutaneous coronary interventions (PCI), and b) patients after a first Stroke between ages 20 - 80, up to two months after the stroke, with a NIH Stroke Score of 6 - 20 and who are able to cooperate and follow instructions.

Methods Part A This research will examine the effect of Aerobic Physical Activity on the function of the Autonomic Nervous System and on various physiological and clinical factors such as B.P., blood sugar level, tryglycerides, HDL, LDL, CRP and aerobic physical fitness, in 70 cardiac patients who participate in the Heart Rehabilitation Program at the Hadassah Hospital on Mt. Scopus and in 30 post Stroke patients.

Control Group I Includes about 70 cardiac patients and about 30 post Stroke patients, thate will NOT include in the Exercise Training Program and ARE suitable with regards to age, sex, and clinical background.

Group II Includes about 30 healthy individuals, suitable for the research groups with regard to age and sex, and have no known cardio-vascular disease and who will participate in Aerobic Exercise Training Program for 3 months.

At the commencement and end of the research:

Patients in the research and control groups will undergo the following tests:-

  1. Stress Test
  2. Measurement of Heart Rate Variability by means of a "Holter" monitor.
  3. General Blood tests (Triglycerides, HDL, LDL, sugar and HB.A1C.CRP)
  4. Quality of life according to SF questionnaire.
  5. B.P and Pulse at rest.
  6. NIH Stroke Scale
  7. MAS (Motor Assessment Scale).
  8. FIM (Functional Independence Scale)
  9. Walking Speed Test; (the distance covered in two minutes) at a comfortable speed. During the test the patient is connected to a Polar Watch (heart rate monitor) to check the Heart Rate.

Physical (Exercise)Training

  1. Each patient will receive a personal training program and his optimal heart rate is determined by the results the stress test according to a Borg scale - a scale for assessing, subjectively, the training intensity level. RPE (Rating of perceived exertion scale)
  2. Duration of program: 3 months, 2 sessions a week, each session lasting 60 minutes.
  3. Session includes about 15 minutes of warm-up, the main part - aerobic workout on exercise machines for 35 minutes, and relaxation for 10 minutes.
  4. The main part includes work on the following fitness machines; treadmill, bicycle and arm ergometria.
  5. The heart rate is monitored constantly during the training, by means of a Polar Watch.
  6. At the start and end of each session, blood pressure is measured, and if necessary also during the session.
  7. The intensity of effort will be examined by means of the Borg Scale (RPE) for a subjective assessment of level of difficulty.

Part B Blood tests at the end of the training program will include a test of ACE Insertion/Deletion Polymorphism.

研究类型

介入性

注册 (预期的)

230

阶段

  • 阶段1

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。

学习联系方式

研究联系人备份

学习地点

      • Jerusalem、以色列
        • Hadassah Medical Organization, Jerusalem, Israel
        • 接触:
        • 接触:
        • 副研究员:
          • Ayelet Giladi, Msc

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

20年 至 80年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria: The research subjects include a) patients after Myocardial Infarction between the ages 20 - 80 , who underwent percutaneous coronary interventions (PCI), and b) patients after a first Stroke between ages 20 - 80, up to two months after the stroke, with a NIH Stroke Score of 6 - 20 and who are able to cooperate and follow instructions.:

-

Exclusion Criteria:1) Unstable Angina Pectoris2) Valvular Heart disease 3) Cardiomyopathy4) uncontrolled Hypertension.5) Cardiac Insufficiency (uncontrolled)6) uncontrolled arrhythmia 7) Severe Skeletal problems, or other physical, mental or medical problems liable to limit the patient' ability to participate.8) Incompliance.9) Patients who develop symptoms during the research, will be removed.

-

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:治疗
  • 分配:随机化
  • 介入模型:阶乘赋值
  • 屏蔽:无(打开标签)

研究衡量的是什么?

主要结果指标

结果测量
HR vriability at 12 weeks

次要结果测量

结果测量
B.P., blood sugar level, tryglycerides, HDL, LDL, CRP and aerobic physical fitness,at 12 weeks.

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:Isabella Schwartz, Dr、Hadassah Medical Organization

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

2006年1月1日

研究注册日期

首次提交

2005年11月30日

首先提交符合 QC 标准的

2005年11月30日

首次发布 (估计)

2005年12月1日

研究记录更新

最后更新发布 (估计)

2005年12月1日

上次提交的符合 QC 标准的更新

2005年11月30日

最后验证

2005年10月1日

更多信息

与本研究相关的术语

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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