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The Effect of Long Duration Exercise on the Diastolic Function of the Heart (PEP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02039154
First Posted: January 17, 2014
Last Update Posted: November 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Benjamin Levine, University of Texas Southwestern Medical Center
  Purpose
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.

Condition Intervention
Aging Behavioral: Aerobic and strength training group Behavioral: Balance and flexibility group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Long Duration Exercise on the Diastolic Function of the Heart

Resource links provided by NLM:


Further study details as provided by Benjamin Levine, University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Change in left ventricular stiffness (diastolic function/static) after training [ Time Frame: Two years ]

Secondary Outcome Measures:
  • Change in diastolic function/dynamic after training [ Time Frame: 2 years ]
  • Change in systolic function after training [ Time Frame: 2 years ]
  • Change in ventricular-vascular coupling after training [ Time Frame: 2 years ]

Enrollment: 61
Actual Study Start Date: July 2012
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aerobic and strength training group Behavioral: Aerobic and strength training group
A exercise training program will be developed individually for each subject with the goal of increasing duration and intensity consistent with modern training techniques. Workouts will vary with respect to mode (walk, cycle, swim), duration (30-60 minutes), and intensity (base, interval, recovery) to optimize the training response. Each subject will be assigned a personal trainer and a heart rate monitor so that every session is carefully tracked and recorded. For intervals, we will use the novel high intensity aerobic intervals (HAIT). Subjects will also perform strength training 1-2 days/week.
Active Comparator: Balance and flexibility group Behavioral: Balance and flexibility group
For the balance and flexibility group, subjects will be encouraged to participate in yoga/tai chi/pilates classes that is approved by one of the exercise physiologists on the research team. The goal for this group is exercise classes that will be of benefit to them, but that will not include sustained aerobic, endurance exercise. In place of a group exercise class, subjects will have the option of purchasing videos for home use. The subjects will be encouraged to participate in some form of non-endurance training at least 3 days per week. Each subject will receive an exercise log in which they will be expected to record their training.

Detailed Description:

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.

  Eligibility

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Ages Eligible for Study:   45 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02039154


Locations
United States, Texas
The Institute for Exercise and Environmental Medicine
Dallas, Texas, United States, 75231
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Benjamin D Levine, MD University of Texas Southwestern Medical Center
  More Information

Responsible Party: Benjamin Levine, Professor of Medicine and Cardiology, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02039154     History of Changes
Other Study ID Numbers: STU 062012-055
First Submitted: December 10, 2013
First Posted: January 17, 2014
Last Update Posted: November 21, 2017
Last Verified: November 2017

Keywords provided by Benjamin Levine, University of Texas Southwestern Medical Center:
Exercise
Exercise tolerance
Aging
Physical activity