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Physical Fitness, Cardiovascular and Brain Health

This study has been completed.
American Federation for Aging Research
Information provided by (Responsible Party):
University of Texas at Austin Identifier:
First received: March 30, 2011
Last updated: April 10, 2014
Last verified: April 2014
The goal of this study is to determine if aerobic exercise or progressive muscle relaxation is associated with changes in cardiovascular health, brain function, and cognition.

Condition Intervention
Behavioral: Aerobic Exercise
Behavioral: Relaxation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Physical Fitness, Cardiovascular and Brain Health

Resource links provided by NLM:

Further study details as provided by University of Texas at Austin:

Primary Outcome Measures:
  • Percent signal change in Blood oxygen level-dependent (BOLD) response to a working memory task [ Time Frame: change from baseline in blood oxygen level-dependent (BOLD) response to WM task at 14 weeks ]
    Blood oxygen level-dependent (BOLD) functional magnetic resonance imaging (fMRI) during 2-Back working memory task

  • N-acetyl aspartate (NAA) concentration [ Time Frame: change from baseline in N-acetyl aspartate (NAA) concentration at 14 weeks ]
    Magnetic resonance spectroscopy (MRS) measurements of N-acetyl-aspartate (NAA)

Enrollment: 41
Study Start Date: March 2011
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aerobic Exersice
12-week moderate aerobic exercise program
Behavioral: Aerobic Exercise
12-week moderate-intensity aerobic exercise program designed in accordance with the recommended guidelines established by the American College of Sports Medicine
Other Name: Exercise
Active Comparator: Relaxation
12-week at home progressive muscle relaxation program
Behavioral: Relaxation
12-week progressive muscle relaxation program (active control)

Detailed Description:
Cognition is the most important determinant of health status, quality of life and functional ability in older age. Therefore, early interventions that preserve and enhance cognitive function are crucial for ensuring successful aging. The most common treatable risk factor for late-life cognitive impairment is midlife hypertension (HTN). One highly promising intervention strategy is aerobic exercise as it has been associated cognitive benefits in non-demented older adults. However, it is still unclear whether this benefit is due simply to prevention of other risk factors (e.g., reductions in blood pressure) or if exercise can reverse the negative effects of HTN on the brain. The goals of the current study are to employ sensitive measures of neuroimaging and cognition in order to 1).Compare cerebral health in endurance trained versus sedentary middle aged adults with normal or borderline to stage 1 hypertension, 2). measure the effects of exercise training in previously sedentary middle aged adults adults with normal or borderline to stage 1 hypertension, and 3). examine if exercise-related differences and changes in neural integrity and cognition are mediated by systemic vascular health.

Ages Eligible for Study:   45 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Sedentary adults Participants will be classified as sedentary if they have not engaged in regular physical exercise for at least one year prior to study enrollment.
  • Ages 45-65
  • Normal blood pressure or Borderline or stage 1 hypertension Borderline hypertension will be defined as systolic blood pressure between 120-139 mmHg and/or diastolic blood pressure between 80-89 mmHg. Stage 1 hypertension will be defined as systolic blood pressure between 140-159 mmHg and/or diastolic blood pressure between 90-99 mmHg.

Exclusion Criteria:

  • Signs or symptoms of chronic heart disease
  • Smoking (current or within the past 6 months)
  • Peripheral artery disease (ankle-brachial index<0.9)
  • Diabetes (fasting blood glucose>126 mg/L)
  • Orthopedic problems that would prohibit participants from participating in exercise.
  • Axis I psychiatric disorder
  • Magnetic resonance contraindications
  • Baseline Intellectual Quotient < 70
  • Below chance performance on the practice items of the cognitive tasks
  • Evidence of large vessel stroke on magnetic resonance imaging
  Contacts and Locations
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Please refer to this study by its identifier: NCT01341145

United States, Texas
University of Texas at Austin
Austin, Texas, United States, 78712
Sponsors and Collaborators
University of Texas at Austin
American Federation for Aging Research
Principal Investigator: Andreana Haley, PhD University of Texas at Austin
Principal Investigator: Hirofumi Tanaka, Ph.D. University of Texas at Austin
  More Information

Responsible Party: University of Texas at Austin Identifier: NCT01341145     History of Changes
Other Study ID Numbers: 2010-04-0106
8A0024 ( Other Grant/Funding Number: American Federation for Aging Reseaerch )
Study First Received: March 30, 2011
Last Updated: April 10, 2014

Keywords provided by University of Texas at Austin:
aerobic exercise
functional magnetic resonance imaging (fMRI)
magnetic resonance spectroscopy (MRS)
brain health

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases processed this record on May 25, 2017