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临床试验/NCT02097199
NCT02097199已完成不适用

Influence of Physical Activity on Promising Atherosclerosis Biomarkers

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2014年8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
98
试验地点
1
主要终点
Change from baseline osteoprotegerin and endocan level to osteoprotegerin and endocan levels after 8 months of increased physical activity workload

研究概览

简要总结

This study investigates the influence of an increased physical activity and sports workload in formerly nonsporting healthy individuals on current promising biomarkers of atherosclerosis research.

详细描述

According to Statistik Austria, cardiovascular disease (CVD) is the most common reason for death in Austria in total population. In 2011, 42,3 % of all deaths were due to CVD (ICD-10 I00-I99). In People aged 45-64 years, CVD is, beyond cancer, the second most common cause of death. According to the "Österreichische Gesundheitsbefragung 2006/7" more than two-thirds of men and three-quarters of women are physically inactive whereby physical inactivity was defined as at least 3x/week of sudatory exercise like cycling, jogging or aerobic.

A very famous study done by Morris et al. in 1953 showed that bus conductors in London (walking job) had half of the coronary heart disease (CHD) mortality compared to bus drivers (sitting job) and therefore initiated the hour of birth of CVD research in connection to physical (in)activity. Cardiorespiratory fitness might reduce does-dependently all cause cardiovascular mortality by 20-30 % (5-8) and the probability of developing CHD by 30-50 % (9-11).

Recently, CVD-research focuses on the investigation of blood-markers which indicate the presence of atherosclerosis and represent risk for development and genesis of CV events. E.g. inflammatory markers such as IL-6, TNF-alpha, ICAM-1, P-selectin, hsCRP and serum amyloid A are promising markers. Studies have shown that hsCRP levels at baseline predict future CV events. Markers of plaque stability are e.g. myeloperoxidase, metalloproteinase-9 and soluble CD-40 ligand. However, the influence of exercise on these factors has already been investigated.

The main dependent variables will be endocan and osteoprotegerin (OPG): OPG is a member of the TNF-related family and involved in bone metabolism. However, high levels of OPG have been reported in association with cardiovascular outcome (CAD, vascular calcification, advanced atherosclerosis, heart failure...). Serum concentrations were found to correlate with severity of peripheral artery disease, carotic stenosis and myocardial infarction. Furthermore, OPG is was associated with left ventricle and left atrial remodelling in patients with severe aortic stenosis, a disease which is often obverse in elderly patients. Age and gender were shown to predict OPG levels, at least in hemodialysis patients. Several studies have been performed investigating the influence of acute exercise or resistance training on circulating OPG amounts but less is known about the influence of long-term physical exercise.

Endocan (endothelial cell specific molecule 1; ESM-1) is a recombinant proteoglycan which may represent a new marker that correlates with CV risk and surrogate endothelial dysfunction playing a role in endothelium-dependent pathological disorders.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

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

入选标准

  • Age 30-65 years
  • less than 30 minutes of quick walking/day
  • Physical ability to perform sports and bicycle stress tests

排除标准

  • Age <30 or >65 years
  • Pregnancy
  • weight >130 kg
  • untreated/uncontrolled hypertension

结局指标

主要结局

Change from baseline osteoprotegerin and endocan level to osteoprotegerin and endocan levels after 8 months of increased physical activity workload

时间窗: Baseline, Month 8

Osteoprotegerin and endocan levels will be measured at baseline, every 2 months of training and at the end of the observation after 8 months

次要结局

  • Change from baseline Progerin, Myeloid-related peptide 8 and 14, Angiopoietin-like protein 2, Cathepsin S and K, Cystatin C and Placental growth factor level to levels after 8 months of increased physical activity workload(Baseline, Month 8)

研究者

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

Jeanette Strametz-Juranek

Prim.Univ.Prof.Dr.

Medical University of Vienna

研究点 (1)

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