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The Effects of Aerobic Exercise Training on Vascular, Cardiac and Cerebral Vascular Function in COPD

2016年8月17日 更新者:University of British Columbia

The Effects of Aerobic Exercise Training on Peripheral Vascular, Cardiac and Cerebral Vascular Function in Patients With Chronic Obstructive Pulmonary Disease

The primary cause of chronic obstructive pulmonary disease is smoking, which can lead to inflammation in the lungs and blood vessels that can lead to secondary problems such as blood vessel disease, high blood pressure and heart disease. Aerobic exercise training has been shown to reduce the risk of heart and brain disease; however, it is currently unknown whether exercise training can have the same affect in patients with COPD. The aim of this study is to investigate how eight weeks of aerobic exercise training improves blood vessel and heart function and brain blood flow in patients with COPD.

研究概览

详细说明

Chronic obstructive pulmonary disease (COPD) is a treatable respiratory condition that is only partially reversible. The primary cause of COPD is smoking which leads to airway inflammation and oxidative damage to the lungs, which has been linked to the development and progression of the disease. The inflammation is not isolated to the lungs as patients with COPD also have systemic inflammation that has been linked to a number of cardiovascular comorbidities such as endothelial dysfunction, cardiovascular disease and stroke. Evidence demonstrates that COPD patients have a greater incidence of vascular dysfunction and adverse vascular remodeling, which worsens with disease severity. In fact, patients with COPD are at 35 times greater risk of developing cardiovascular disease and stroke than healthy aged matched individuals. In healthy individuals and a number of chronic conditions, aerobic exercise training is well established to reduce the risk of cardiovascular and cerebrovascular disease. The benefits of exercise are likely through improvements in endothelial function, systemic inflammation, and cardiac and cerebral vascular function. However, whether exercise training can have the same effects in a chronic inflammatory condition like COPD has not been studied. The purpose of this study is to determine the effectiveness of an 8 week aerobic exercise training program in patient's chronic obstructive pulmonary disease as determined by improvements in endothelial function, systemic inflammation and cardiac and cerebral vascular function.

研究类型

介入性

注册 (实际的)

58

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

    • British Columbia
      • Kelowna、British Columbia、加拿大、V1V 1V7
        • University of British Columbia

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

40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:

  • Non-smokers (>6 months);
  • Forced expiratory volume in one second/ forced vital capacity (FEV1/FVC) < 0.7 and FEV1/FVC <lower limit of normal
  • Stable (>3 months exacerbation free)

Exclusion Criteria:

  • On supplemental oxygen;
  • Known cardiac or cerebral vascular disease, diabetes, obstructive sleep apnea;
  • Uncontrolled hypertension;
  • BMI >30kg/m2
  • Currently performing pulmonary rehabilitation or structured exercise training;
  • Desaturate during exercise (SpO2<85%)
  • Cardiovascular contraindications to exercise in the incremental test used for screening

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:非随机化
  • 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
实验性的:Patients with COPD
Stable patients with COPD participated in an 8-week (24 session) individualized, non-linear aerobic exercise training program consisting of upper and lower body cycle ergometry.
Aerobic exercise performed on lower body stationary ergometer and an upper extremity arm crank. Intensity (50-95% workload maximum) and durations (20-45 min) are fluctuated daily to optimize training stress and adaptation
有源比较器:Healthy Controls
Age, sex, BMI and activity matched controls participated in an 8-week (24 session) individualized, non-linear aerobic exercise training program consisting of upper and lower body cycle ergometry.
Aerobic exercise performed on lower body stationary ergometer and an upper extremity arm crank. Intensity (50-95% workload maximum) and durations (20-45 min) are fluctuated daily to optimize training stress and adaptation

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
Endothelial Function
大体时间:8-weeks (following 24 sessions of exercise training)
The change in brachial artery flow mediated dilation measured using reactive hyperaemia
8-weeks (following 24 sessions of exercise training)

次要结果测量

结果测量
措施说明
大体时间
Arterial Stiffness
大体时间:8-weeks (following 24 sessions of exercise training)
The change in pulse wave velocity measured using tonometry
8-weeks (following 24 sessions of exercise training)
Carotid intima-medial thickness
大体时间:8-weeks (following 24 sessions of exercise training)
The change in carotid intima-medial thickness measured by ultrasound
8-weeks (following 24 sessions of exercise training)
Carotid Compliance
大体时间:8-weeks (following 24 sessions of exercise training)
The change in carotid compliance measured using tonometry and ultrasound for the carotid arteries
8-weeks (following 24 sessions of exercise training)
Inflammatory Biomarkers
大体时间:8-weeks (following 24 sessions of exercise training)
The change in serum levels of CRP, IL-6, IL-10 and TNF-alpha measured using Luminex multiplex bead-based technology
8-weeks (following 24 sessions of exercise training)
Systolic function
大体时间:8-weeks (following 24 sessions of exercise training)
The change in stroke volume using echocardiography
8-weeks (following 24 sessions of exercise training)
Diastolic function
大体时间:8-weeks (following 24 sessions of exercise training)
The change in left ventricular end-diastolic volume using echocardiography
8-weeks (following 24 sessions of exercise training)
Cerebral Blood Flow
大体时间:8-weeks (following 24 sessions of exercise training)
The change in cerebral and neck blood flow using ultrasound
8-weeks (following 24 sessions of exercise training)
Cerebrovascular Reactivity
大体时间:8-weeks (following 24 sessions of exercise training)
The change in middle cerebral artery velocity in response to carbon dioxide
8-weeks (following 24 sessions of exercise training)
Cerebrovascular Autoregulation
大体时间:8-weeks (following 24 sessions of exercise training)
The change in phase delay measured by transfer function analysis
8-weeks (following 24 sessions of exercise training)

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:Neil Eves, PhD、University of British Columbia

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。

一般刊物

  • Gelinas JC, Lewis NC, Harper MI, Ainslie PN, Rolf JD, Eves ND. Aerobic Exercise Training on Peripheral Vascular Structure and Function in Patients with Chronic Obstructive Pulmonary Disease. American Journal of Respiratory and Critical Care Medicine, 191:A5305, 2015.

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

2012年1月1日

初级完成 (实际的)

2015年5月1日

研究完成 (实际的)

2015年5月1日

研究注册日期

首次提交

2016年8月4日

首先提交符合 QC 标准的

2016年8月17日

首次发布 (估计)

2016年8月23日

研究记录更新

最后更新发布 (估计)

2016年8月23日

上次提交的符合 QC 标准的更新

2016年8月17日

最后验证

2016年8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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