The Munich Cardiovascular Adaptation in Young Athletes Plus Study
- Conditions
- Exercise
- Registration Number
- NCT06259617
- Lead Sponsor
- Technical University of Munich
- 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?
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 250
- 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
- Presence of an acute infection, acute orthopedic injury, or chronic disease
- Missing consent from the participant and/or legal guardian
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Left Ventricular internal end diastolic diameter (LVIDd) Once every year over 3 years Echocardiographic assessment, result in (mm)
Vascular stiffness Once every year over 3 years Vascular stiffness of the A. carotis communis, sonographic assessment, result in (%) strain
Right atrial peak contraction strain (R-PACS) Once every year over 3 years Echocardiographic assessment, result in (%)
Left ventricular posterior wall end diastole (LVPWd) Once every year over 3 years Echocardiographic assessment, result in (mm)
Relative wall thickness (RWT) Once every year over 3 years Echocardiographic assessment, result in (mm)
Fractional shortening (FS) 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) Once every year over 3 years Echocardiographic assessment, result in (cm/s)
Peripheral and central blood pressure Once every year over 3 years Assessment via blood pressure cuff, result in (mmHg)
Pulse Wave VelocityLeft ventricular mass (LVM) Once every year over 3 years Echocardiographic assessment, result in (g)
Left Atrial and Right Atrial Volume/Body Surface Area Once every year over 3 years Echocardiographic assessment, result in (ml/m²)
Left atrial total strain Once every year over 3 years Echocardiographic assessment, result in (%)
Intima-Media-Thickness (IMT) 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 Once every year over 3 years Assessment via blood pressure cuff, result in (mmHg)
Pulse Wave Velocity Once every year over 3 years Assessment via blood pressure cuff, result in (ms)
Interventricular septum thickness (IVSd) Once every year over 3 years Echocardiographic assessment, result in (mm)
Ejection fraction (EF) Once every year over 3 years Echocardiographic assessment, result in (%)
Left Atrial Diameter and Right Atrial Diameter and Diameter/Body Surface Area Once every year over 3 years Echocardiographic assessment, result in (cm)
Left atrial peak contraction strain (L-PACS) Once every year over 3 years Echocardiographic assessment, result in (%)
Global longitudinal strain (GLS) Once every year over 3 years Echocardiographic assessment, result in (%)
Left ventricular systolic function (S', S) Once every year over 3 years Echocardiographic assessment, result in (cm/s)
Left atrial peak longitudinal strain (L-PALS) Once every year over 3 years Echocardiographic assessment, result in (%)
Right atrial peak longitudinal strain (R-PALS) Once every year over 3 years Echocardiographic assessment, result in (%)
- Secondary Outcome Measures
Name Time Method Height Once every year over 3 years Measured via Stadiometer, result in (cm)
Bodyfat percentage Once every year over 3 years Measured via bioelectric impedance scale, result in (%)
Fat-free mass Once every year over 3 years Measured via bioelectric impedance scale, result in (kg)
Nutritional Status 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.
Body-Mass-Index Once every year over 3 years Calculated from Heigt and Weight, result in (kg/m²)
Muscle mass Once every year over 3 years Measured via bioelectric impedance scale, result in (kg)
Waist circumference Once every year over 3 years Measured via measuring tape, result in (cm)
Sitting height (cm) Once every year over 3 years Measured via Stadiometer, result in (cm)
GOT (AST) Once every year over 3 years Venous blood sampling and laboratory analysis, result in (U/L)
Cholesterol Once every year over 3 years Venous blood sampling and laboratory analysis, result in (mg/dL)
Physical Fitness Once every year over 3 years Spiroergometric measure of VO2max
Training Frequency Once every year over 3 years Assessment of training frequency via the MoMo activity questionnaire, result in (minutes/week)
Medical history 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
Weight Once every year over 3 years Measured on scale, result in (kg)
Fat mass Once every year over 3 years Measured via bioelectric impedance scale, result in (kg)
Hip circumference Once every year over 3 years Measured via measuring tape, result in (cm)
GPT (ALT) Once every year over 3 years Venous blood sampling and laboratory analysis, result in (U/L)
HDL-Cholesterol Once every year over 3 years Venous blood sampling and laboratory analysis, result in (mg/dL)
Erythrocytes Once every year over 3 years Venous blood sampling and laboratory analysis, result in (/pL),
Non-HDL (calc.) Once every year over 3 years Venous blood sampling and laboratory analysis, result in (mg/dL)
Uric acid Once every year over 3 years Venous blood sampling and laboratory analysis, result in (mg/dL)
fT3 Once every year over 3 years Venous blood sampling and laboratory analysis, result in (pg/mL)
HBE/MCH Once every year over 3 years Venous blood sampling and laboratory analysis, result in (pg)
MCV Once every year over 3 years Venous blood sampling and laboratory analysis, result in (fL)
Hematocrit Once every year over 3 years Venous blood sampling and laboratory analysis, result in (%)
Water content Once every year over 3 years Measured via bioelectric impedance scale, result in (L)
GGT Once every year over 3 years Venous blood sampling and laboratory analysis, result in (U/L)
LDL-Cholesterol Once every year over 3 years Venous blood sampling and laboratory analysis, result in (mg/dL)
Creatinine Once every year over 3 years Venous blood sampling and laboratory analysis, result in (mg/dL)
Nitric Oxide Once every year over 3 years Venous blood sampling, blood plasma preparation and laboratory analysis, result in (μmol/L)
hsCRP Once every year over 3 years Venous blood sampling and laboratory analysis, result in (mg/dL)
Glutathion peroxidase Once every year over 3 years Venous blood sampling and laboratory analysis, result in (U/L)
Superoxide dismutase Once every year over 3 years Venous blood sampling and laboratory analysis, result in (U/mL)
Leptin Once every year over 3 years Venous blood sampling, blood plasma preparation and laboratory analysis, result in (ng/mL)
Training intensity Once every year over 3 years Assessment of training intensity via the MoMo activity questionnaire, result in (metabolic equivalent task-minutes/week)
Endothelin-1 Once every year over 3 years Venous blood sampling, blood plasma preparation and laboratory analysis, result in (pg/mL)
Ferritin Once every year over 3 years Venous blood sampling, blood plasma preparation and laboratory analysis, result in (ng/mL)
Hemoglobin Once every year over 3 years Venous blood sampling and laboratory analysis, result in (g/dL)
MCHC Once every year over 3 years Venous blood sampling and laboratory analysis, result in (g/dL)
Heart Rate Once every year over 3 years Assessment via blood pressure cuff, result in (bpm)
RDW (Ery) Once every year over 3 years Venous blood sampling and laboratory analysis, result in (%)
Thrombocytes Once every year over 3 years Venous blood sampling and laboratory analysis, result in (Tsnd/µL)
Leukocytes Once every year over 3 years Venous blood sampling and laboratory analysis, result in (/nL)
Trial Locations
- Locations (1)
Sportmedizinische Ambulanz für Kinder und Jugendliche
🇩🇪München, Bavaria, Germany