跳至主要内容
临床试验/NCT02039154
NCT02039154已完成不适用

The Effect of Long Duration Exercise on the Diastolic Function of the Heart

University of Texas Southwestern Medical Center1 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2012年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
61
试验地点
1
主要终点
Change in left ventricular stiffness (diastolic function/static) after training

研究概览

简要总结

The purpose of this study is to determine whether vigorous exercise training 4-5 days/week for 2 years in sedentary middle aged men and women (ages 45-64) will improve cardiac and vascular compliance to a degree equivalent to life-long exercisers and the sedentary young. Sedentary aging is associated with impaired diastolic function, which can lead to heart failure. However, if exercise training can be implemented early enough in life while cardiovascular plasticity still exists, then functional capacity can be maintained, preventing heart failure.

详细描述

Objectives: Chronic physical inactivity contributes to the deaths of nearly 1 in 10 Americans. In seniors, the single most common life-threatening disease is congestive heart failure and for these patients, abnormalities of diastolic function play a critical role in the pathophysiology of their disease. The primary investigator's previous research has demonstrated that: a) healthy but sedentary aging leads to atrophy and stiffening of the heart with reduced myocardial and chamber compliance; b) in contrast, highly competitive senior athletes had cardiac compliance that was indistinguishable from healthy young individuals suggesting that lifelong exercise training prevented this stiffening; c) even prolonged and intense exercise training started after age 65 failed to reverse age-related cardiac and vascular stiffening; d) cardiac stiffening begins in middle age (45-64) and can be substantially prevented by training 4-5 days/wk. The primary objective of this project, is therefore to identify sedentary individuals aged 45-64, and initiate an exercise program carefully designed to maximize effects on cardiovascular compliance and function. After this aim is accomplished, we will have established a novel, practical exercise training strategy designed to prevent the cardiovascular stiffening with aging, improve the functional capacity in our aging population, and ultimately to prevent Heart failure with preserved Ejection Fraction. Such a determination would have enormous public health significance since this condition is quite difficult to treat once established.

Hypothesis

The investigators hypothesize that exercise training implemented 4-5 times/week for 2 yrs in sedentary middle aged men and women (45-64yr) will improve cardiac and vascular compliance to a degree equivalent to life-long exercisers (and sedentary young). The investigators will perform invasive and non-invasive assessment of cardiovascular structure and function before and after an exercise program involving high intensity aerobic intervals, lower intensity endurance ("base training"), and strength training.

Specific Aim: To test our hypothesis, there will be two groups of previously sedentary subjects, ages 45-64 for 2 years, with the following interventions: 1) subjects undergoing prolonged endurance/interval/strength exercise training; and 2) yoga/balance control.

A comprehensive set of "Baseline Testing" (prior to the two year intervention) and "Follow-up Testing" (after the two year intervention) will take place to assess the effects of the intervention. This testing will include submaximal and maximal exercise testing as well as comprehensive invasive (right heart catheterization) and non-invasive (ultrasound) measures of cardiac mechanics, relaxation and morphology. From these data, the following indices of diastolic and systolic function will be generated: Starling and pressure/volume curves; calculations of left ventricle wall stress and strain; and measurements of flow propagation velocity, ejection fraction and relaxation velocity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
45 Years 至 64 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •healthy, sedentary men and women
  • •ages 45-64
  • •body mass index <30
  • •absence of co-morbid conditions including hypertension, diabetes, heart failure, asthma, chronic obstructive pulmonary disease, coronary artery disease as evidenced by angina or prior myocardial infarction or cerebrovascular disease as evidenced by prior transient ischemic attack or stroke

排除标准

  • •healthy, active (aerobic exercisers greater than 2 days per week) men and women
  • •ages less than 45 or over 64
  • •body mass index >30
  • •presence of co-morbid conditions including hypertension, diabetes, heart failure, asthma, chronic obstructive pulmonary disease, coronary artery disease as evidenced by angina or prior myocardial infarction or cerebrovascular disease as evidenced by prior transient ischemic attack or stroke
  • •Patients with chronic orthopedic injury that might make them unable to participate in an exercise testing will also be excluded
  • •Subjects unable to speak English will not be recruited because of the complex experimental studies and the need for precise communication between the volunteers and the research staff to ensure safety.

研究组 & 干预措施

Aerobic and strength training group

Experimental

干预措施: Aerobic and strength training group (Behavioral)

Balance and flexibility group

Active Comparator

干预措施: Balance and flexibility group (Behavioral)

结局指标

主要结局

Change in left ventricular stiffness (diastolic function/static) after training

时间窗: Two years

次要结局

  • Change in systolic function after training(2 years)
  • Change in diastolic function/dynamic after training(2 years)
  • Change in ventricular-vascular coupling after training(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验