Skip to main content
Clinical Trials/NCT06259617
NCT06259617
Recruiting
Not Applicable

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 site in 1 country250 target enrollmentDecember 1, 2023
ConditionsExercise

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Exercise
Sponsor
Technical University of Munich
Enrollment
250
Locations
1
Primary Endpoint
Vascular stiffness
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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?

Registry
clinicaltrials.gov
Start Date
December 1, 2023
End Date
September 2026
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Technical University of Munich
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Vascular stiffness

Time Frame: 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)

Time Frame: Once every year over 3 years

Echocardiographic assessment, result in (mm)

Right atrial peak contraction strain (R-PACS)

Time Frame: Once every year over 3 years

Echocardiographic assessment, result in (%)

Left ventricular posterior wall end diastole (LVPWd)

Time Frame: Once every year over 3 years

Echocardiographic assessment, result in (mm)

Relative wall thickness (RWT)

Time Frame: Once every year over 3 years

Echocardiographic assessment, result in (mm)

Fractional shortening (FS)

Time Frame: 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)

Time Frame: Once every year over 3 years

Echocardiographic assessment, result in (cm/s)

Peripheral and central blood pressure

Time Frame: Once every year over 3 years

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

Left ventricular mass (LVM)

Time Frame: Once every year over 3 years

Echocardiographic assessment, result in (g)

Left Atrial and Right Atrial Volume/Body Surface Area

Time Frame: Once every year over 3 years

Echocardiographic assessment, result in (ml/m²)

Left atrial total strain

Time Frame: Once every year over 3 years

Echocardiographic assessment, result in (%)

Intima-Media-Thickness (IMT)

Time Frame: 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

Time Frame: Once every year over 3 years

Assessment via blood pressure cuff, result in (mmHg)

Pulse Wave Velocity

Time Frame: Once every year over 3 years

Assessment via blood pressure cuff, result in (ms)

Interventricular septum thickness (IVSd)

Time Frame: Once every year over 3 years

Echocardiographic assessment, result in (mm)

Ejection fraction (EF)

Time Frame: Once every year over 3 years

Echocardiographic assessment, result in (%)

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

Time Frame: Once every year over 3 years

Echocardiographic assessment, result in (cm)

Left atrial peak contraction strain (L-PACS)

Time Frame: Once every year over 3 years

Echocardiographic assessment, result in (%)

Global longitudinal strain (GLS)

Time Frame: Once every year over 3 years

Echocardiographic assessment, result in (%)

Left ventricular systolic function (S', S)

Time Frame: Once every year over 3 years

Echocardiographic assessment, result in (cm/s)

Left atrial peak longitudinal strain (L-PALS)

Time Frame: Once every year over 3 years

Echocardiographic assessment, result in (%)

Right atrial peak longitudinal strain (R-PALS)

Time Frame: Once every year over 3 years

Echocardiographic assessment, result in (%)

Secondary Outcomes

  • 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)

Study Sites (1)

Loading locations...

Similar Trials