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临床试验/NCT04791306
NCT04791306已完成不适用

Impact of a 4 Months Training Intervention on Exercise-induced Changes of Heart Health-related Epigenetic Markers in Healthy, Sedentary Individuals

Paracelsus Medical University2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2021年7月1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
46
试验地点
2
主要终点
miRNA expression response to acute all-out exercise (ergometry)

研究概览

简要总结

We aim to analyze the impact of a single acute exercise intervention (ergometry) on the expression pattern of specific heart health related miRNAs in healthy, previously sedentary participants, and how this pattern will be changed after 4 months of increasing the weekly physical activity >150 minutes.

详细描述

Exercise induced changes in heat health related miRNA expression pattern are analyzed in plasma samples collected at rest and immediately after the completion of an all-out ergo spirometry test, conducted during the baseline examination. Additionally participants will perform a pulse wave analysis to evaluate their arterial stiffness, a bioimpedanzanalysis to evaluate their body composition, blood lipids will be measured as well as their exercise capacity.

After the baseline examination, all participants will perform once per week a supervised endurance and strength training at our facility. In addition, the participants will be provided with a digital application for planning and documentation of their home based physical activity. Together with an expert, they plan their weekly physical activities so that they reach 150 min of physical activity each week over a period of 4 months.

After this training/exercise intervention all participants will perform all measurements from the baseline examination again.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • <150min physical activity per week
  • >18 years of age
  • male and female
  • signed inform consents

排除标准

  • acute or chronic cardiovascular diseases, exempt arterial hypertension (systolic blood pressure >140 mmHg and diastolic blood pressure >90 mmHg in untreated and medical treated subjects)
  • acute or chronic lung disease
  • Alcohol (>30g/day) or drug abuse
  • Adipositas grad 2 (BMI >35kg/m²)
  • Orthopedic limitations to exercise capacity
  • pregnant or breast feeding women

结局指标

主要结局

miRNA expression response to acute all-out exercise (ergometry)

时间窗: Baseline

expression change of miRNA due to all-out ergometry at baseline

Change from baseline in miRNA expression response to acute all-out exercise (ergometry) at 4 months

时间窗: after 4 months of exercise intervention

4 months of exercise intervention in healthy previously sedentary participants leads to a change in the acute exercise response (all-out ergometry).

Change from baseline miRNA expression at 4 months

时间窗: after 4 months of exercise intervention

4 months of exercise intervention in healthy previously sedentary participants leads to exercise-induced changes in the cardio protective miRNA expression profiles

次要结局

  • blood lipides(Before and after 4 months of exercise intervention)
  • arterial stiffness(Before and after 4 months of exercise intervention)
  • Heart rate(Before and after 4 months of exercise intervention)
  • digital application(4 months of exercise intervention)
  • body composition(Before and after 4 months of exercise intervention)
  • exercise capacity(Before and after 4 months of exercise intervention)
  • body weight(Before and after 4 months of exercise intervention)

研究者

发起方
Paracelsus Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Josef Niebauer M.D., Ph.D., MBA

Prim. Univ.Prof.Dr.Dr. Josef Niebauer, MBA

Paracelsus Medical University

研究点 (2)

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