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Effect of Exercise and Diet on Inflammation in Hypertensive Individuals

Primary Purpose

Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Program
Combined Exercise and Diet Program
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Inflammation, Blood Pressure, High

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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 hypertension") Arthritis, exertional asthma, or any other disorder likely to be made worse by exercise Pregnant

Sites / Locations

  • University of California, San Diego

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

No Intervention

Arm Label

1

2

3

Arm Description

12-week exercise program

12-week combined exercise and diet program

Non-intervention group

Outcomes

Primary Outcome Measures

CRP
Interleukin-6 (IL-6)
Tumor necrosis factor-alpha (TNF-alpha)
Soluble intercellular adhesion molecule-1 (sICAM-1)
SE-selectin
Leukocyte CD11a expression
Leukocyte CD11b expression
Leukocyte activation
Peripheral blood mononuclear cell chemotaxis

Secondary Outcome Measures

Physical fitness
Weight
Blood pressure

Full Information

First Posted
June 16, 2006
Last Updated
June 7, 2012
Sponsor
University of California, San Diego
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00338572
Brief Title
Effect of Exercise and Diet on Inflammation in Hypertensive Individuals
Official Title
Sympathetic Nervous System Regulation of Cell Adhesion
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Inflammation, Blood Pressure, High

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
185 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
12-week exercise program
Arm Title
2
Arm Type
Experimental
Arm Description
12-week combined exercise and diet program
Arm Title
3
Arm Type
No Intervention
Arm Description
Non-intervention group
Intervention Type
Behavioral
Intervention Name(s)
Exercise Program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Combined Exercise and Diet Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
CRP
Time Frame
Measured at 4 years
Title
Interleukin-6 (IL-6)
Time Frame
Measured at 4 years
Title
Tumor necrosis factor-alpha (TNF-alpha)
Time Frame
Measured at 4 years
Title
Soluble intercellular adhesion molecule-1 (sICAM-1)
Time Frame
Measured at 4 years
Title
SE-selectin
Time Frame
Measured at 4 years
Title
Leukocyte CD11a expression
Time Frame
Measured at 4 years
Title
Leukocyte CD11b expression
Time Frame
Measured at 4 years
Title
Leukocyte activation
Time Frame
Measured at 4 years
Title
Peripheral blood mononuclear cell chemotaxis
Time Frame
Measured at 4 years
Secondary Outcome Measure Information:
Title
Physical fitness
Time Frame
Measured at 4 years
Title
Weight
Time Frame
Measured at 4 years
Title
Blood pressure
Time Frame
Measured at 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 hypertension") Arthritis, exertional asthma, or any other disorder likely to be made worse by exercise Pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul J. Mills, PhD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States

12. IPD Sharing Statement

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Effect of Exercise and Diet on Inflammation in Hypertensive Individuals

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