Physical Fitness, Cardiovascular and Brain Health

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78712
      • University of Texas at Austin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Exercise
Active Comparator: Relaxation; 12-week at home progressive muscle relaxation program	Behavioral: Relaxation; 12-week progressive muscle relaxation program (active control)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent signal change in Blood oxygen level-dependent (BOLD) response to a working memory task	Blood oxygen level-dependent (BOLD) functional magnetic resonance imaging (fMRI) during 2-Back working memory task	change from baseline in blood oxygen level-dependent (BOLD) response to WM task at 14 weeks
N-acetyl aspartate (NAA) concentration	Magnetic resonance spectroscopy (MRS) measurements of N-acetyl-aspartate (NAA)	change from baseline in N-acetyl aspartate (NAA) concentration at 14 weeks

Collaborators and Investigators

• Sponsor: University of Texas at Austin
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: March 30, 2011
• First Submitted That Met QC Criteria: April 21, 2011
• First Posted (Estimate): April 25, 2011

Study Record Updates

• Last Update Posted (Estimate): April 14, 2014
• Last Update Submitted That Met QC Criteria: April 10, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: hypertension; aerobic exercise; relaxation; brain health; functional magnetic resonance imaging (fMRI); magnetic resonance spectroscopy (MRS)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 2010-04-0106; 8A0024 (Other Grant/Funding Number: American Federation for Aging Reseaerch)