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Physical Fitness, Cardiovascular and Brain Health

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
American Federation for Aging Research
Information provided by (Responsible Party):
University of Texas at Austin
ClinicalTrials.gov Identifier:
NCT01341145
First received: March 30, 2011
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

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
Hypertension
 Behavioral: Aerobic Exercise
Behavioral: Relaxation

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

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Magnetic resonance spectroscopy (MRS) measurements of N-acetyl-aspartate (NAA)


Estimated Enrollment: 30
Study Start Date: March 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 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.

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 IQ < 70
  • Below chance performance on the practice items of the cognitive tasks
  • Evidence of large vessel stroke on magnetic resonance imaging
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01341145

Locations
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
Investigators
Principal Investigator: Andreana Haley, PhD University of Texas at Austin
Principal Investigator: Hirofumi Tanaka, Ph.D. University of Texas at Austin
  More Information

No publications provided

Responsible Party: University of Texas at Austin
ClinicalTrials.gov Identifier: NCT01341145     History of Changes
Other Study ID Numbers: 2010-04-0106, 8A0024
Study First Received: March 30, 2011
Last Updated: January 15, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013