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

NCT02039154 | Completed DMC

• 1 other identifier: STU 062012-055
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aging

Keywords

Exercise; Exercise tolerance; Aging; Physical activity

Outcome Measures

Primary Outcomes (1)

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

  Two years

Secondary Outcomes (3)

• Change in diastolic function/dynamic after training

  2 years

• Change in systolic function after training

  2 years

• Change in ventricular-vascular coupling after training

  2 years

Study Arms (2)

Aerobic and strength training group

EXPERIMENTAL

Behavioral: Aerobic and strength training group

Balance and flexibility group

ACTIVE COMPARATOR

Behavioral: Balance and flexibility group

Interventions

Aerobic and strength training group BEHAVIORAL

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.

Aerobic and strength training group

Balance and flexibility group BEHAVIORAL

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.

Balance and flexibility group

Eligibility Criteria

• Age: 45 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

The Institute for Exercise and Environmental Medicine

Dallas, Texas, 75231, United States

Location

Related Publications (4)

• Hieda M, Sarma S, Hearon CM Jr, Dias KA, Martinez J, Samels M, Everding B, Palmer D, Livingston S, Morris M, Howden E, Levine BD. Increased Myocardial Stiffness in Patients With High-Risk Left Ventricular Hypertrophy: The Hallmark of Stage-B Heart Failure With Preserved Ejection Fraction. Circulation. 2020 Jan 14;141(2):115-123. doi: 10.1161/CIRCULATIONAHA.119.040332. Epub 2019 Dec 23.

  PMID: 31865771 DERIVED

• McNamara DA, Aiad N, Howden E, Hieda M, Link MS, Palmer D, Samels M, Everding B, Ng J, Adams-Huet B, Opondo M, Sarma S, Levine BD. Left Atrial Electromechanical Remodeling Following 2 Years of High-Intensity Exercise Training in Sedentary Middle-Aged Adults. Circulation. 2019 Mar 19;139(12):1507-1516. doi: 10.1161/CIRCULATIONAHA.118.037615.

  PMID: 30586729 DERIVED

• Opondo MA, Aiad N, Cain MA, Sarma S, Howden E, Stoller DA, Ng J, van Rijckevorsel P, Hieda M, Tarumi T, Palmer MD, Levine BD. Does High-Intensity Endurance Training Increase the Risk of Atrial Fibrillation? A Longitudinal Study of Left Atrial Structure and Function. Circ Arrhythm Electrophysiol. 2018 May;11(5):e005598. doi: 10.1161/CIRCEP.117.005598.

  PMID: 29748195 DERIVED

• Howden EJ, Sarma S, Lawley JS, Opondo M, Cornwell W, Stoller D, Urey MA, Adams-Huet B, Levine BD. Reversing the Cardiac Effects of Sedentary Aging in Middle Age-A Randomized Controlled Trial: Implications For Heart Failure Prevention. Circulation. 2018 Apr 10;137(15):1549-1560. doi: 10.1161/CIRCULATIONAHA.117.030617. Epub 2018 Jan 8.

  PMID: 29311053 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Benjamin D Levine, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2013
• First Posted: January 17, 2014
• Study Start: July 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: May 19, 2020

Record last verified: 2020-05

Locations

US (1)