Clinical trial NCT01341145: Physical Fitness, Cardiovascular and Brain Health
Official title: Physical Fitness, Cardiovascular and Brain Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: hypertension
aerobic exercise
relaxation
functional magnetic resonance imaging (fMRI)
magnetic resonance spectroscopy (MRS)
brain health
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: American Federation for Aging Research
First posted: 2011-04-25
Enrollment: 41
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percent signal change in Blood oxygen level-dependent (BOLD) response to a working memory task
timeFrame: change from baseline in blood oxygen level-dependent (BOLD) response to WM task at 14 weeks
measure: N-acetyl aspartate (NAA) concentration
timeFrame: change from baseline in N-acetyl aspartate (NAA) concentration at 14 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Andreana Haley, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas at Austin
name: Hirofumi Tanaka, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: