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Sympathetic Nervous System Regulation of Cell Adhesion

25 Years
60 Years
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Trial Information

Sympathetic Nervous System Regulation of Cell Adhesion

Hypertension is characterized by high blood pressure, as well as by inflammation and
increased adhesion among blood cells. Inflammation may play an important role in
atherosclerosis, which involves the build up of fatty deposits on the inside wall of
arteries. Pharmacological treatment for hypertension successfully reduces blood pressure.
However, it has limited effectiveness for reducing the associated inflammation. Losing
weight and increasing physical activity have been shown to reduce general inflammation, but
more research is needed to determine their effect on inflammation that is directly related
to hypertension. The purpose of this study is to evaluate the effectiveness of an exercise
program versus a combined exercise and diet program at reducing inflammation and cell
adhesion in hypertensive individuals.

This study will enroll inactive and overweight hypertensive individuals. Participants will
be randomly assigned to a 12-week exercise program, a 12-week combined exercise and diet
program, or a non-intervention group. At study entry, participants will take part in a
speech stressor task, a VO2 peak exercise test, and an exercise treadmill test. During the
speech stressor task, participants will be videotaped while they talk about potentially
stressful situations. Prior to and following the speech task, blood will be collected, blood
pressure and heart rate will be recorded, and standardized questionnaires will be completed
to assess anger, anxiety, and stress levels. The two exercise tests will occur within 5 days
of each other and both will involve running on a treadmill. Heart rate, respiratory rate,
and physical activity intensity will be monitored; heart activity will be measured by an
electrocardiogram (ECG). Blood will be collected at various times during the testing
procedures to measure levels of inflammation biomarkers, including C-reactive protein (CRP)
and white blood cells. Perceived exertion and stress levels will also be assessed.

Participants in the exercise intervention will receive a 12-week membership to the YMCA and
will meet with a personal trainer twice a week. They will be encouraged to exercise on their
own for an additional 3 to 4 days per week. Participants will also be provided with a
pedometer, which will track the number of steps they take each day. Participants in the diet
program will meet with a dietician and will be encouraged to reduce their caloric intake by
incorporating low-fat, high-fiber foods into their diet. Throughout the study, participants
will have regular follow-up phone calls with study staff and meetings with their personal
trainer and/or dietician to ensure that they are adhering to their assigned program. At the
end of 12 weeks, participants will return for a repeat speech stressor task, a VO2 peak
exercise test, and an exercise treadmill test. Participants in the non-intervention group
will then be assigned to either the exercise program or combined exercise and diet program.

Inclusion Criteria:

- Unmedicated hypertension with blood pressure greater than 140/90 mm Hg but less than
175/104 mm Hg

- Body mass index (BMI) of 23.5 to 34

- Relatively inactive, as defined by the Leisure Time Exercise Questionnaire

- Willing and able to participate in the assigned study group

- Postmenopausal women not on hormone replacement therapy (HRT) and premenopausal women

Exclusion Criteria:

- Abnormal echocardiogram

- Recent stroke or significant brain impairment

- Current psychiatric disease

- History of psychosis or major depression

- Currently taking psychotropic drugs

- Currently taking any medications (e.g., anti-inflammatory medications) other than
antihypertensives (which will be tapered)

- Current drug and/or alcohol abuse

- Consumes more than 600 mg of caffeine per day

- Diabetes

- Congestive heart failure

- Bronchospastic pulmonary disease

- History of heart attacks

- Known secondary high blood pressure

- Angina

- History of life-threatening arrhythmias

- History of kidney damage

- Current participation in regular or structured exercise classes, or regular physical
exercise in the 6 months prior to study entry

- Inability to perform moderate to vigorous intensity exercise

- Current participation in a diet

- High blood pressure, only when measured in a doctor's office (i.e., "white coat

- Arthritis, exertional asthma, or any other disorder likely to be made worse by

- Pregnant

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:

Measured at 4 years

Safety Issue:


Principal Investigator

Paul J. Mills, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Diego


United States: Federal Government

Study ID:




Start Date:

June 2006

Completion Date:

April 2012

Related Keywords:

  • Hypertension
  • Inflammation
  • Blood Pressure, High
  • Hypertension
  • Inflammation



University of California, San Diego La Jolla, California  92037-1709