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临床试验/NCT06259617
NCT06259617招募中不适用

Influence of Vigorous Physical Activity and Metabolic Parameters on Structure and Function of the Cardiovascular System in Young Athletes - the MuCAYAplus - Study (Munich Cardiovascular Adaptation in Young Athletes Study)

Technical University of Munich1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2023年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
250
试验地点
1
主要终点
Vascular stiffness

研究概览

简要总结

The aim of the 3-year longitudinal study is to investigate the cardiovascular system's response to training loads in young athletes. For the first time, these parameters will be examined alongside biochemical and metabolic laboratory measures, as well as body composition. The study focuses on the impact of training frequency and intensity, as well as performance, on cardiovascular structure and function.

The following research questions are being investigated:

What structural and functional cardiovascular changes can be observed in young athletes compared to the norm?

What is the relationship between cardiac and vascular parameters depending on the athletic load (training frequency and intensity) as well as athletic performance?

Do cardiac/vascular parameters change over the course of the study, and what role do athletic load (training frequency and intensity) as well as athletic performance play?

What laboratory chemical changes can be observed in young athletes depending on the athletic load (training frequency and intensity) as well as athletic performance?

What connections exist between laboratory chemical parameters and cardiac and vascular parameters in young athletes?

Is there a correlation between structural and functional cardiovascular changes and body composition as well as eating behavior?

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
7 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Participants aged ≥7 and <18 years, presenting for sports medical examination and meeting the criteria mentioned for a period of 3 years
  • Athletes participating in competitions, engaging in regular training in a primary sport, being members of a club or association, and training ≥3 hours per week
  • The last intensive training must have occurred 12 hours ago to ensure sufficient recovery
  • No acute infection, confirmed by a medical examination on the day of testing
  • No orthopedic injury, confirmed by a medical examination on the day of testing
  • No chronic disease, confirmed by a medical examination on the day of testing
  • Clearance for cardiopulmonary stress testing after a medical examination on the day of testing
  • Annual participation (1 time per year) in the sports medical examination for 3 years
  • Maintaining regular training, training duration ≥3 hours per week, and participation in competitions

排除标准

  • Presence of an acute infection, acute orthopedic injury, or chronic disease
  • Missing consent from the participant and/or legal guardian

结局指标

主要结局

Vascular stiffness

时间窗: Once every year over 3 years

Vascular stiffness of the A. carotis communis, sonographic assessment, result in (%) strain

Left Ventricular internal end diastolic diameter (LVIDd)

时间窗: Once every year over 3 years

Echocardiographic assessment, result in (mm)

Right atrial peak contraction strain (R-PACS)

时间窗: Once every year over 3 years

Echocardiographic assessment, result in (%)

Left ventricular posterior wall end diastole (LVPWd)

时间窗: Once every year over 3 years

Echocardiographic assessment, result in (mm)

Relative wall thickness (RWT)

时间窗: Once every year over 3 years

Echocardiographic assessment, result in (mm)

Fractional shortening (FS)

时间窗: Once every year over 3 years

Echocardiographic assessment, result in (%)

Left ventricular diastolic function (E', E/E', A', E'/A', E-Wave, A-Wave, E/A)

时间窗: Once every year over 3 years

Echocardiographic assessment, result in (cm/s)

Peripheral and central blood pressure

时间窗: Once every year over 3 years

Assessment via blood pressure cuff, result in (mmHg) Pulse Wave Velocity

Left ventricular mass (LVM)

时间窗: Once every year over 3 years

Echocardiographic assessment, result in (g)

Left Atrial and Right Atrial Volume/Body Surface Area

时间窗: Once every year over 3 years

Echocardiographic assessment, result in (ml/m²)

Left atrial total strain

时间窗: Once every year over 3 years

Echocardiographic assessment, result in (%)

Intima-Media-Thickness (IMT)

时间窗: Once every year over 3 years

Intima-Media-Thickness (IMT) of the A. carotis communis, sonographic assessment, result in (mm)

Peripheral and central pulse pressure

时间窗: Once every year over 3 years

Assessment via blood pressure cuff, result in (mmHg)

Pulse Wave Velocity

时间窗: Once every year over 3 years

Assessment via blood pressure cuff, result in (ms)

Interventricular septum thickness (IVSd)

时间窗: Once every year over 3 years

Echocardiographic assessment, result in (mm)

Ejection fraction (EF)

时间窗: Once every year over 3 years

Echocardiographic assessment, result in (%)

Left Atrial Diameter and Right Atrial Diameter and Diameter/Body Surface Area

时间窗: Once every year over 3 years

Echocardiographic assessment, result in (cm)

Left atrial peak contraction strain (L-PACS)

时间窗: Once every year over 3 years

Echocardiographic assessment, result in (%)

Global longitudinal strain (GLS)

时间窗: Once every year over 3 years

Echocardiographic assessment, result in (%)

Left ventricular systolic function (S', S)

时间窗: Once every year over 3 years

Echocardiographic assessment, result in (cm/s)

Left atrial peak longitudinal strain (L-PALS)

时间窗: Once every year over 3 years

Echocardiographic assessment, result in (%)

Right atrial peak longitudinal strain (R-PALS)

时间窗: Once every year over 3 years

Echocardiographic assessment, result in (%)

次要结局

  • Height(Once every year over 3 years)
  • Bodyfat percentage(Once every year over 3 years)
  • Fat-free mass(Once every year over 3 years)
  • Nutritional Status(Once every year over 3 years)
  • Body-Mass-Index(Once every year over 3 years)
  • Muscle mass(Once every year over 3 years)
  • Waist circumference(Once every year over 3 years)
  • Sitting height (cm)(Once every year over 3 years)
  • GOT (AST)(Once every year over 3 years)
  • Cholesterol(Once every year over 3 years)
  • Physical Fitness(Once every year over 3 years)
  • Training Frequency(Once every year over 3 years)
  • Medical history(Once every year over 3 years)
  • Weight(Once every year over 3 years)
  • Fat mass(Once every year over 3 years)
  • Hip circumference(Once every year over 3 years)
  • GPT (ALT)(Once every year over 3 years)
  • HDL-Cholesterol(Once every year over 3 years)
  • Erythrocytes(Once every year over 3 years)
  • Non-HDL (calc.)(Once every year over 3 years)
  • Uric acid(Once every year over 3 years)
  • fT3(Once every year over 3 years)
  • HBE/MCH(Once every year over 3 years)
  • MCV(Once every year over 3 years)
  • Hematocrit(Once every year over 3 years)
  • Water content(Once every year over 3 years)
  • GGT(Once every year over 3 years)
  • LDL-Cholesterol(Once every year over 3 years)
  • Creatinine(Once every year over 3 years)
  • Nitric Oxide(Once every year over 3 years)
  • hsCRP(Once every year over 3 years)
  • Glutathion peroxidase(Once every year over 3 years)
  • Superoxide dismutase(Once every year over 3 years)
  • Leptin(Once every year over 3 years)
  • Training intensity(Once every year over 3 years)
  • Endothelin-1(Once every year over 3 years)
  • Ferritin(Once every year over 3 years)
  • Hemoglobin(Once every year over 3 years)
  • MCHC(Once every year over 3 years)
  • Heart Rate(Once every year over 3 years)
  • RDW (Ery)(Once every year over 3 years)
  • Thrombocytes(Once every year over 3 years)
  • Leukocytes(Once every year over 3 years)

研究者

发起方
Technical University of Munich
申办方类型
Other
责任方
Sponsor

研究点 (1)

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