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NCT Number: NCT06259617

The Munich Cardiovascular Adaptation in Young Athletes Plus Study

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?

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Key information

Conditions

Exercise Behavior Motor Activity

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sportmedizinische Ambulanz für Kinder und Jugendliche

München, Bavaria, 80992, Germany

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Vascular stiffness

    Time frame: Once every year over 3 years

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

  2. Peripheral and central blood pressure

    Time frame: Once every year over 3 years

    Assessment via blood pressure cuff, result in (mmHg)

    Pulse Wave Velocity

  3. Left Ventricular internal end diastolic diameter (LVIDd)

    Time frame: Once every year over 3 years

    Echocardiographic assessment, result in (mm)

  4. Left ventricular posterior wall end diastole (LVPWd)

    Time frame: Once every year over 3 years

    Echocardiographic assessment, result in (mm)

  5. Interventricular septum thickness (IVSd)

    Time frame: Once every year over 3 years

    Echocardiographic assessment, result in (mm)

  6. Left ventricular mass (LVM)

    Time frame: Once every year over 3 years

    Echocardiographic assessment, result in (g)

  7. Relative wall thickness (RWT)

    Time frame: Once every year over 3 years

    Echocardiographic assessment, result in (mm)

  8. Ejection fraction (EF)

    Time frame: Once every year over 3 years

    Echocardiographic assessment, result in (%)

  9. Fractional shortening (FS)

    Time frame: Once every year over 3 years

    Echocardiographic assessment, result in (%)

  10. 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)

  11. Left ventricular systolic function (S', S)

    Time frame: Once every year over 3 years

    Echocardiographic assessment, result in (cm/s)

  12. 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)

  13. Left Atrial and Right Atrial Volume/Body Surface Area

    Time frame: Once every year over 3 years

    Echocardiographic assessment, result in (ml/m²)

  14. Left atrial peak longitudinal strain (L-PALS)

    Time frame: Once every year over 3 years

    Echocardiographic assessment, result in (%)

  15. Left atrial peak contraction strain (L-PACS)

    Time frame: Once every year over 3 years

    Echocardiographic assessment, result in (%)

  16. Left atrial total strain

    Time frame: Once every year over 3 years

    Echocardiographic assessment, result in (%)

  17. Right atrial peak longitudinal strain (R-PALS)

    Time frame: Once every year over 3 years

    Echocardiographic assessment, result in (%)

  18. Right atrial peak contraction strain (R-PACS)

    Time frame: Once every year over 3 years

    Echocardiographic assessment, result in (%)

  19. Global longitudinal strain (GLS)

    Time frame: Once every year over 3 years

    Echocardiographic assessment, result in (%)

  20. 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)

  21. Peripheral and central pulse pressure

    Time frame: Once every year over 3 years

    Assessment via blood pressure cuff, result in (mmHg)

  22. Pulse Wave Velocity

    Time frame: Once every year over 3 years

    Assessment via blood pressure cuff, result in (ms)

Secondary outcomes

  1. Physical Fitness

    Time frame: Once every year over 3 years

    Spiroergometric measure of VO2max

  2. Nutritional Status

    Time frame: Once every year over 3 years

    Assessment of dietary habits and nutritional status via the validated Healthy Eating Index (HEI).Originally developed in the USA, it was adapted to the German recommendations on food consumption.Higher scores are associated with higher compliance with the official diet recommendations.

  3. Training Frequency

    Time frame: Once every year over 3 years

    Assessment of training frequency via the MoMo activity questionnaire, result in (minutes/week)

  4. Medical history

    Time frame: Once every year over 3 years

    Current illnesses/injuries,Vaccination status, Allergies, Medication, Dietary supplements, Alcohol- and nicotine consumption, Drug use, Energy Drinks, Dietary Habits, Menarche and menstrual cycle in girls Family history of cardiovascular diseases, Unclear deaths, Sudden cardiac death, Marfan syndrome Training history, Symptoms during exercise such as shortness of breath, dizziness/syncope, palpitations or chest pain

  5. Height

    Time frame: Once every year over 3 years

    Measured via Stadiometer, result in (cm)

  6. Weight

    Time frame: Once every year over 3 years

    Measured on scale, result in (kg)

  7. Body-Mass-Index

    Time frame: Once every year over 3 years

    Calculated from Heigt and Weight, result in (kg/m²)

  8. Bodyfat percentage

    Time frame: Once every year over 3 years

    Measured via bioelectric impedance scale, result in (%)

  9. Fat mass

    Time frame: Once every year over 3 years

    Measured via bioelectric impedance scale, result in (kg)

  10. Fat-free mass

    Time frame: Once every year over 3 years

    Measured via bioelectric impedance scale, result in (kg)

  11. Muscle mass

    Time frame: Once every year over 3 years

    Measured via bioelectric impedance scale, result in (kg)

  12. Water content

    Time frame: Once every year over 3 years

    Measured via bioelectric impedance scale, result in (L)

  13. Waist circumference

    Time frame: Once every year over 3 years

    Measured via measuring tape, result in (cm)

  14. Hip circumference

    Time frame: Once every year over 3 years

    Measured via measuring tape, result in (cm)

  15. Sitting height (cm)

    Time frame: Once every year over 3 years

    Measured via Stadiometer, result in (cm)

  16. Erythrocytes

    Time frame: Once every year over 3 years

    Venous blood sampling and laboratory analysis, result in (/pL),

  17. GOT (AST)

    Time frame: Once every year over 3 years

    Venous blood sampling and laboratory analysis, result in (U/L)

  18. GPT (ALT)

    Time frame: Once every year over 3 years

    Venous blood sampling and laboratory analysis, result in (U/L)

  19. GGT

    Time frame: Once every year over 3 years

    Venous blood sampling and laboratory analysis, result in (U/L)

  20. Cholesterol

    Time frame: Once every year over 3 years

    Venous blood sampling and laboratory analysis, result in (mg/dL)

  21. HDL-Cholesterol

    Time frame: Once every year over 3 years

    Venous blood sampling and laboratory analysis, result in (mg/dL)

  22. Non-HDL (calc.)

    Time frame: Once every year over 3 years

    Venous blood sampling and laboratory analysis, result in (mg/dL)

  23. LDL-Cholesterol

    Time frame: Once every year over 3 years

    Venous blood sampling and laboratory analysis, result in (mg/dL)

  24. Creatinine

    Time frame: Once every year over 3 years

    Venous blood sampling and laboratory analysis, result in (mg/dL)

  25. Uric acid

    Time frame: Once every year over 3 years

    Venous blood sampling and laboratory analysis, result in (mg/dL)

  26. hsCRP

    Time frame: Once every year over 3 years

    Venous blood sampling and laboratory analysis, result in (mg/dL)

  27. fT3

    Time frame: Once every year over 3 years

    Venous blood sampling and laboratory analysis, result in (pg/mL)

  28. Glutathion peroxidase

    Time frame: Once every year over 3 years

    Venous blood sampling and laboratory analysis, result in (U/L)

  29. Superoxide dismutase

    Time frame: Once every year over 3 years

    Venous blood sampling and laboratory analysis, result in (U/mL)

  30. Endothelin-1

    Time frame: Once every year over 3 years

    Venous blood sampling, blood plasma preparation and laboratory analysis, result in (pg/mL)

  31. Nitric Oxide

    Time frame: Once every year over 3 years

    Venous blood sampling, blood plasma preparation and laboratory analysis, result in (μmol/L)

  32. Ferritin

    Time frame: Once every year over 3 years

    Venous blood sampling, blood plasma preparation and laboratory analysis, result in (ng/mL)

  33. Leptin

    Time frame: Once every year over 3 years

    Venous blood sampling, blood plasma preparation and laboratory analysis, result in (ng/mL)

  34. Training intensity

    Time frame: Once every year over 3 years

    Assessment of training intensity via the MoMo activity questionnaire, result in (metabolic equivalent task-minutes/week)

  35. Hemoglobin

    Time frame: Once every year over 3 years

    Venous blood sampling and laboratory analysis, result in (g/dL)

  36. HBE/MCH

    Time frame: Once every year over 3 years

    Venous blood sampling and laboratory analysis, result in (pg)

  37. MCV

    Time frame: Once every year over 3 years

    Venous blood sampling and laboratory analysis, result in (fL)

  38. Hematocrit

    Time frame: Once every year over 3 years

    Venous blood sampling and laboratory analysis, result in (%)

  39. MCHC

    Time frame: Once every year over 3 years

    Venous blood sampling and laboratory analysis, result in (g/dL)

  40. RDW (Ery)

    Time frame: Once every year over 3 years

    Venous blood sampling and laboratory analysis, result in (%)

  41. Thrombocytes

    Time frame: Once every year over 3 years

    Venous blood sampling and laboratory analysis, result in (Tsnd/µL)

  42. Leukocytes

    Time frame: Once every year over 3 years

    Venous blood sampling and laboratory analysis, result in (/nL)

  43. Heart Rate

    Time frame: Once every year over 3 years

    Assessment via blood pressure cuff, result in (bpm)

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Collaborators

  • German Research Foundation

Registry information

Official study 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)

Acronym: MuCAYAplus

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 14, 2024
Registry last updated
Feb 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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