HypertensionNCT01341145
Physical Fitness, Cardiovascular and Brain Health
A study testing Aerobic Exercise and Relaxation in people with Hypertension, run by University of Texas at Austin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Aerobic Exercise and Relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Aerobic Exercise, Relaxation
- Keywords
- hypertension, aerobic exercise, relaxation, functional magnetic resonance imaging (fMRI), magnetic resonance spectroscopy (MRS), brain health
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseBehavioural
Also called Exercise
12-week moderate-intensity aerobic exercise program designed in accordance with the recommended guidelines established by the American College of Sports Medicine
RelaxationBehavioural
12-week progressive muscle relaxation program (active control)
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exersice | Experimental | 12-week moderate aerobic exercise program Receives: Behavioral: Aerobic Exercise |
| Relaxation | Active comparator | 12-week at home progressive muscle relaxation program Receives: Behavioral: Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: change from baseline in N-acetyl aspartate (NAA) concentration at 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- American Federation for Aging Research
- Responsible party
- Principal investigator, Andreana P. Haley, University of Texas at Austin
- Investigators
- Andreana Haley, PhD, Principal investigator, University of Texas at AustinHirofumi Tanaka, Ph.D., Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01341145
- Sponsor's protocol ID
- 2010-04-0106
- Other IDs
- 8A0024
- Status last verified
- Apr 2014
- First submitted
- 30 Mar 2011
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Fitness, Cardiovascular and Brain Health
- ClinicalTrials.gov ID
- NCT01341145
- Acronym / sponsor ID
- 2010-04-0106
- Conditions
- Hypertension
- Keywords
- hypertension, aerobic exercise, relaxation, functional magnetic resonance imaging (fMRI), magnetic resonance spectroscopy (MRS), brain health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- American Federation for Aging Research
- Study start
- Mar 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 25 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exersice | Experimental | Behavioral: Aerobic Exercise12-week moderate aerobic exercise program |
| Relaxation | Active comparator | Behavioral: Relaxation12-week at home progressive muscle relaxation program |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic ExerciseAlso: Exercise12-week moderate-intensity aerobic exercise program designed in accordance with the recommended guidelines established by the American College of Sports Medicine | Behavioural | Aerobic Exersice |
| Relaxation12-week progressive muscle relaxation program (active control) | Behavioural | Relaxation |
Primary outcome
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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreana Haley, PhD principal investigator
University of Texas at Austin
Hirofumi Tanaka, Ph.D. principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise and Relaxation in people with Hypertension, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.