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临床试验/NCT05235958
NCT05235958已完成不适用

Vascular Effects of Non-linear Periodized Exercise Training in Sedentary Adults With Elevated Cardiovascular Risk - The VascuFit Project

Karsten Königstein2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2022年5月2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
43
试验地点
2
主要终点
Brachial-arterial flow-mediated vasodilation (baFMD)

研究概览

简要总结

Exercise is a cornerstone of health care helping to improve and maintain a good organ functionality, including vascular function, in health and disease. About twenty years ago, the introduction of high-intensity training has been a milestone in the evolution of exercise therapy by demonstrating the trainability of individuals independent of age and state of disease. Today, its practical implementation still faces barriers, such as lower physical and mental tolerance of exercise, long-term adherence and lack of individualization of training for optimal adaptations.

The proposed project is the logical next step to introduce non-linear periodized exercise training (NLPE), a method widely established in elite athletes, in exercise training of sedentary individuals. NLPE alternatingly involves person-centred periodization of training cycles and regeneration with high-intensity stimuli. It induces a broader range of physiological adaptations than moderate-intensity training while keeping a high compliance and without increasing the risk of overreaching. A study of patients with chronic-obstructive-pulmonary-disease and a study with resistance training of older adults indicated promising pulmonary and muscular effects. However, the effectiveness of NLPE to maintain and improve vascular function has not yet been assessed, although this may carry a huge clinical and socioeconomic potential by contributing to the reduction of cardiovascular morbidity and mortality.

VascuFit applies an 8-week training intervention to assess the effects of NLPE on the function of the vascular endothelium, measured by the non-invasive gold-standard method brachial arterial flow-mediated dilation (baFMD), in a sample of sedentary aging adults with cardiovascular risk factors. In addition, it will be the first study to measure training effects on a cluster of micro-ribonucleic acids (miRNAs) regulating key molecular pathways of endothelial (dys-)function. Thus, VascuFit aims to explore the potential of clinical and molecular biomarkers for the monitoring of individual vascular adaptability to a specific type of exercise. As a first step, this pilot-project is supposed to deliver proof-of-concept. Furthermore, it will generate important hypotheses to be addressed by exercise physiologists, medical professionals and biologists concerned with the optimization of individual training adaptations as well as utility and implementation of targeted training approaches in the health care of aging adults.

VascuFit aims to demonstrate the potential of NLPE as a training regimen to improve vascular function in sedentary individuals with elevated cardiovascular risk. This project may be the initial spark to raise exercise training to the next level, which is clearly necessary to sustainably strengthen the vascular capacities of "young" aging individuals.

详细描述

A detailed description of the study can be found at:

DOI: 10.1186/s12872-022-02905-1

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Informed consent, documented by signature
  • sedentary lifestyle, as not performing exercise on a regular basis and reaching less than the recommended 7.5 MET hours of at least moderate intensity activity per week
  • being mentally and physically able to attend and keep up training during the whole intervention period.

排除标准

  • current or chronic condition limiting exhaustive exercise (e.g. heart failure, infection, pulmonary disease)
  • any condition with elevated risk of a serious adverse event during exhaustive exercise (e.g. cardiomyopathy, acute myocardial infarction, stroke, uncontrolled hypertensive resting blood pressure ≥160/100mmHg)
  • chronic condition with severe affection of the vascular system (e.g. severe atherosclerosis, severe chronic kidney disease, autoimmune vasculitis, insulin dependent diabetes mellitus)
  • inability to follow advice during measurements and training sessions (e.g. language barriers, psychological disorders, dementia)
  • previous enrollment into the current study or participation in another study in the last four weeks.

结局指标

主要结局

Brachial-arterial flow-mediated vasodilation (baFMD)

时间窗: 8 weeks

Non-invasive ultrasound-based measurement of endothelial responsiveness of the brachial artery to an hyperemic stimulus. Changes of baFMD after the 8-week study period in comparison to the pre-intervention baseline values will be assessed.

次要结局

  • endomiR(8 weeks)

研究者

发起方
Karsten Königstein
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Karsten Königstein

Clinical Scientist

University of Basel

研究点 (2)

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