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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL057265 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | 12-week exercise program |
|
| 2 | Experimental | 12-week combined exercise and diet program |
|
| 3 | No Intervention | Non-intervention group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| CRP | Measured at 4 years | |
| Interleukin-6 (IL-6) | Measured at 4 years | |
| Tumor necrosis factor-alpha (TNF-alpha) | Measured at 4 years | |
| Soluble intercellular adhesion molecule-1 (sICAM-1) | Measured at 4 years | |
| SE-selectin | Measured at 4 years | |
| Leukocyte CD11a expression | Measured at 4 years | |
| Leukocyte CD11b expression | Measured at 4 years | |
| Leukocyte activation | Measured at 4 years | |
| Peripheral blood mononuclear cell chemotaxis | Measured at 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Physical fitness | Measured at 4 years | |
| Weight | Measured at 4 years | |
| Blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul J. Mills, PhD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | San Diego | California | 92103 | United States |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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|
| Combined Exercise and Diet Program | Behavioral | 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. |
|
| Measured at 4 years |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |