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Physical Fitness, Cardiovascular and Brain Health

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ClinicalTrials.gov Identifier: NCT01341145
Recruitment Status : Completed
First Posted : April 25, 2011
Last Update Posted : April 14, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Hypertension Behavioral: Aerobic Exercise Behavioral: Relaxation

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Physical Fitness, Cardiovascular and Brain Health
Study Start Date : March 2011
Primary Completion Date : April 2014
Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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)

Outcome Measures

Primary Outcome Measures :
  1. 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

  2. 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)

Eligibility Criteria

Information from the National Library of Medicine

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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

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): 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
ClinicalTrials.gov Identifier: NCT01341145     History of Changes
Other Study ID Numbers: 2010-04-0106
8A0024 ( Other Grant/Funding Number: American Federation for Aging Reseaerch )
First Posted: April 25, 2011    Key Record Dates
Last Update Posted: April 14, 2014
Last Verified: April 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