跳至主要内容
临床试验/NCT04166903
NCT04166903已完成不适用

Prospective Long Term Follow-up Analysis of Exercise-induced Physiological Changes in Male Runners

Technical University of Munich1 个研究点 分布在 1 个国家目标入组 277 人开始时间: 2019年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
277
试验地点
1
主要终点
Changes of right ventricular systolic function (RV-EF)

研究概览

简要总结

Pro-MagIC is a prospective observational study and includes participants of the Be-MaGIC-Study 2009 (n=277/NCT00933218). We aim to detect exercise-induced physiological changes (inter alia of the cardiovascular system) induced by repetitive ultra-endurance strain over a period of 10 years.

详细描述

Physical activity is associated with health benefits. Acute prolonged and strenuous exercise, i.e. Marathon running, leads to hemodynamic, endothelial and myocardial functional changes. Whether these myocardial, endothelial and hemodynamic changes can also develop and persist through repetitive extreme and prolonged physical activity is currently still a matter of controversy. In addition, it is not known whether adaptations and changes over time can develop into clinically relevant cardiovascular events with negative health consequences in healthy athletes. The aim of this study is to detect exercise-induced physiological changes (inter alia of the cardiovascular system) induced by repetitive ultra-endurance strain over a period of 10 years.

For this purpose, 277 male participants from the Be-MaGIC study (Marathon 2009) are examined in this prospective observational study. A single examination with the following components will take place: Anthropometry, clinical examination, laboratory, resting / exercise electrocardiography cardiopulmonary stress test, echocardiography, and fundus camera. Further examinations will be conducted in participants with abnormal examination results in line with current clinical recommendations.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
30 Years 至 70 Years(Adult, Older Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •Declaration of consent Participants must have participated in the Be-MaGIC study in 2009
  • •current age: 30 - 70 years
  • •sex: male

排除标准

  • 未提供

结局指标

主要结局

Changes of right ventricular systolic function (RV-EF)

时间窗: 10 years

Echocardiography

次要结局

  • Change in cardiac markers (e.g. cardiac Troponin)(10 years)
  • Change in inflammation markers (e.g. C-reactive Protein)(10 years)
  • Change of prevalence of cardiovascular diseases(10 years)
  • Changes in left ventricular ejection fraction (LV-EF)(10 years)
  • Changes in left ventricular diastolic function (E/e´)(10 years)
  • Change in microcirculation (e.g. arteriolar-to-venular ratio)(10 years)
  • Change in macrocirculation (e.g. Intima media thickness)(10 years)
  • Association between changes of aforementioned parameters (see Topics 1-8) and potential underlying causes (e.g. sports history like number of ultraendurance competitions) in the examined cohort(10 years)

研究者

发起方
Technical University of Munich
申办方类型
Other
责任方
Principal Investigator
主要研究者

Johannes Scherr

Prof. Dr. med. Johannes Scherr

Balgrist University Hospital

研究点 (1)

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