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Recruiting NCT06259617

The Munich Cardiovascular Adaptation in Young Athletes Plus Study

Observational Exercise

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Exercise. Basic parameters: 7 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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)

Overview

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?

Primary outcome measures

  • Vascular stiffness [Time frame: Once every year over 3 years]
  • Peripheral and central blood pressure [Time frame: Once every year over 3 years]
  • Left Ventricular internal end diastolic diameter (LVIDd) [Time frame: Once every year over 3 years]
  • Left ventricular posterior wall end diastole (LVPWd) [Time frame: Once every year over 3 years]
  • Interventricular septum thickness (IVSd) [Time frame: Once every year over 3 years]
  • Left ventricular mass (LVM) [Time frame: Once every year over 3 years]
  • Relative wall thickness (RWT) [Time frame: Once every year over 3 years]
  • Ejection fraction (EF) [Time frame: Once every year over 3 years]
  • Fractional shortening (FS) [Time frame: Once every year over 3 years]
  • Left ventricular diastolic function (E', E/E', A', E'/A', E-Wave, A-Wave, E/A) [Time frame: Once every year over 3 years]
Secondary outcome measures (12)
  • Physical Fitness [Time frame: Once every year over 3 years]
  • Nutritional Status [Time frame: Once every year over 3 years]
  • Training Frequency [Time frame: Once every year over 3 years]
  • Medical history [Time frame: Once every year over 3 years]
  • Height [Time frame: Once every year over 3 years]
  • Weight [Time frame: Once every year over 3 years]
  • Body-Mass-Index [Time frame: Once every year over 3 years]
  • Bodyfat percentage [Time frame: Once every year over 3 years]
  • Fat mass [Time frame: Once every year over 3 years]
  • Fat-free mass [Time frame: Once every year over 3 years]
  • Muscle mass [Time frame: Once every year over 3 years]
  • Water content [Time frame: Once every year over 3 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • Sportmedizinische Ambulanz für Kinder und Jugendliche — München

Publications

  • Baumgartner L, Schulz T, Oberhoffer R, Weberruss H. Influence of Vigorous Physical Activity on Structure and Function of the Cardiovascular System in Young Athletes-The MuCAYA-Study. Front Cardiovasc Med. 2019 Oct 9;6:148. doi: 10.3389/fcvm.2019.00148. eCollection 2019. PMID 31649936

Identifiers

NCT: NCT06259617 · 516547656

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗