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临床试验/NCT00338572
NCT00338572已完成不适用

Sympathetic Nervous System Regulation of Cell Adhesion

University of California, San Diego2 个研究点 分布在 1 个国家目标入组 185 人开始时间: 2006年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
185
试验地点
2
主要终点
CRP

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
25 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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
  • Congestive heart failure
  • Bronchospastic pulmonary disease
  • History of heart attacks
  • Known secondary high blood pressure
  • 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

结局指标

主要结局

CRP

时间窗: Measured at 4 years

Interleukin-6 (IL-6)

时间窗: Measured at 4 years

Tumor necrosis factor-alpha (TNF-alpha)

时间窗: Measured at 4 years

Soluble intercellular adhesion molecule-1 (sICAM-1)

时间窗: Measured at 4 years

SE-selectin

时间窗: Measured at 4 years

Leukocyte CD11a expression

时间窗: Measured at 4 years

Leukocyte CD11b expression

时间窗: Measured at 4 years

Leukocyte activation

时间窗: Measured at 4 years

Peripheral blood mononuclear cell chemotaxis

时间窗: Measured at 4 years

次要结局

  • Weight(Measured at 4 years)
  • Blood pressure(Measured at 4 years)
  • Physical fitness(Measured at 4 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Paul J. Mills

Professor

University of California, San Diego

研究点 (2)

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