Effect of Exercise and Diet on Inflammation in Hypertensive Individuals
Condition: Hypertension
MeSH terms: Hypertension; Inflammation
Study type: Interventional

Summary: 
      In addition to high blood pressure, hypertension is characterized by inflammation, which is
      the body's response to injury or infection. Inflammation has been found to cause plaque
      formation on artery walls. This study will compare the effect of an exercise program versus a
      combined exercise and diet program on reducing inflammation in hypertensive individuals.
    

Detailed description: 
      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.
    

Intervention name(s): Exercise Program; Combined Exercise and Diet Program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants in the exercise group 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 this group 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. They will meet with a dietician and will be encouraged to reduce their caloric intake by incorporating low-fat, high-fiber foods into their diet.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Inflammation; Blood Pressure, High