跳至主要内容
临床试验/NCT01741779
NCT01741779已完成不适用

The Effect of Diet and Whole-body Vibration Training on Cardiovascular and Autonomic Function in Obese Postmenopausal Women

Florida State University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年9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
60
试验地点
2
主要终点
Body Composition

研究概览

简要总结

Obesity is a major risk factor for premature arterial abnormalities including high blood pressure and increased stiffness. Previous studies have shown that weight loss via lifestyle modifications is associated with a decrease in large artery (aorta) stiffness. However, along with decreases in fat mass, hypocaloric diet reduces muscle mass. Whole body vibration results in similar increases in muscle mass and strength than those observed after resistance exercise and is feasible for special populations such as the obese and the elderly.

The investigators hypothesis is that weight loss via diet combined with whole body vibration training would additively reduce arterial stiffness and blood pressure in obese women. The investigators also hypothesize that the improved arterial function with weight loss would be associated with beneficial changes in the main mechanisms involved in BP regulation.

详细描述

The purpose of the study is to examine the effects of 12 weeks of whole body vibration training (WBVT) and diet on arterial function, autonomic function, and body composition in obese women. Specific aims of the study are to:

To evaluate the extent to which diet and (WBVT) will improve body composition assessed by changes in fat mass and lean mass using dual-energy x-ray absorptiometry and waist circumference.

To investigate that combined diet and (WBVT) are more efficacious than either treatment alone in ameliorating cardiovascular disease risk factors by assessing arterial stiffness (aortic, systemic, and leg), aortic BP and wave reflection, and autonomic function (heart rate variability, vascular sympathetic activity [low-frequency power of systolic BP variability], and baroreflex sensitivity). Flow mediated dilation and circulating levels of adipocytokines (adiponectin and leptin) and endothelial-derived vasodilators (NO metabolites [NOx], 6-keto PGFIa, insulin, and ghrelin) and vasoconstrictors (endothelin-1 [ET-1],8-iso PGF2a,vascular endothelium growth factor [VGEF]) will be assessed as secondary outcome variables.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
45 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 45 to 65 years of age
  • At least 1 year after menopause
  • Body mass index of 27-39.9
  • Sedentary or low active (less than 2 hr per wk)

排除标准

  • Younger than 45 or older than 65 years of age
  • Body mass index lower than 27, or 40 or higher
  • Physically active or competitively active
  • Use of hormone replacement therapy of less than 1 yr
  • Use of calcium channel blocker or beta blockers
  • Use dietary supplementations (e.g.,L-arginine,L-citrulline,antioxidants)
  • Uncontrolled diabetes
  • Any restriction that would significantly interfere with compliance with the diet (e.g., allergy to nuts or dairy, or need to avoid soy)

结局指标

主要结局

Body Composition

时间窗: 12 weeks

By measuring fat mass and lean soft tissue mass from dual-energy x-ray absorptiometry and waist circumference

Pressure Wave Reflection

时间窗: 12 weeks

Using the augmentation index from radial tonometry

Blood pressure

时间窗: 12 weeks

Non-invasive measures of brachial and aortic blood pressure

Autonomic Function

时间窗: 12 weeks

Heart rate variability, vascular sympathetic activity \[low-frequency power of systolic BP variability\], and spontaneous baroreflex sensitivity will be assessed from electrocardiogram and beat-by-beat digital blood pressure

Arterial Stiffness

时间窗: 12 weeks

Using pulse wave velocity of the aorta, systemic, and legs

次要结局

  • Endothelial Function(12 weeks)

研究者

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

Arturo Figueroa

Associate Professor

Florida State University

研究点 (2)

Loading locations...

相似试验