Physical Fitness, Cardiovascular and Brain Health

NCT ID: NCT01341145

Last Updated: 2014-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2014-04-30

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.

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aerobic Exersice

12-week moderate aerobic exercise program

Group Type: EXPERIMENTAL

Aerobic Exercise

Intervention Type: BEHAVIORAL

12-week moderate-intensity aerobic exercise program designed in accordance with the recommended guidelines established by the American College of Sports Medicine

Relaxation

12-week at home progressive muscle relaxation program

Group Type: ACTIVE_COMPARATOR

Relaxation

Intervention Type: BEHAVIORAL

12-week progressive muscle relaxation program (active control)

Interventions

Aerobic Exercise

12-week moderate-intensity aerobic exercise program designed in accordance with the recommended guidelines established by the American College of Sports Medicine

Intervention Type: BEHAVIORAL

Relaxation

12-week progressive muscle relaxation program (active control)

Intervention Type: BEHAVIORAL

Other Intervention Names

Exercise

Eligibility 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 Intellectual Quotient < 70
• Below chance performance on the practice items of the cognitive tasks
• Evidence of large vessel stroke on magnetic resonance imaging

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Federation for Aging Research

OTHER

Sponsor Role: collaborator

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andreana Haley, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Austin

Hirofumi Tanaka, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Austin

Locations

University of Texas at Austin

Austin, Texas, United States

Countries

United States

Other Identifiers

8A0024

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2010-04-0106

Identifier Type: -

Identifier Source: org_study_id