The Munich Cardiovascular Adaptation in Young Athletes Plus Study

Exercise Clinical Trial

— MuCAYAplus  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06259617
• Other study ID #: 516547656
• Status: Recruiting
• Start date: December 1, 2023
• Est. completion date: September 2026

Study information

• Verified date: February 2024
• Source: Technical University of Munich
• Contact: Tobias Engl, Dipl. Sportwiss. Univ.
• Phone: +49 89 289 24598
• Email: tobias.engl[@]tum.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Exercise

Locations

Country	Name	City	State
Germany	Sportmedizinische Ambulanz für Kinder und Jugendliche	München	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
Technical University of Munich	German Research Foundation

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vascular stiffness	Vascular stiffness of the A. carotis communis, sonographic assessment, result in (%) strain	Once every year over 3 years
Primary	Peripheral and central blood pressure	Assessment via blood pressure cuff, result in (mmHg); Pulse Wave Velocity	Once every year over 3 years
Primary	Left Ventricular internal end diastolic diameter (LVIDd)	Echocardiographic assessment, result in (mm)	Once every year over 3 years
Primary	Left ventricular posterior wall end diastole (LVPWd)	Echocardiographic assessment, result in (mm)	Once every year over 3 years
Primary	Interventricular septum thickness (IVSd)	Echocardiographic assessment, result in (mm)	Once every year over 3 years
Primary	Left ventricular mass (LVM)	Echocardiographic assessment, result in (g)	Once every year over 3 years
Primary	Relative wall thickness (RWT)	Echocardiographic assessment, result in (mm)	Once every year over 3 years
Primary	Ejection fraction (EF)	Echocardiographic assessment, result in (%)	Once every year over 3 years
Primary	Fractional shortening (FS)	Echocardiographic assessment, result in (%)	Once every year over 3 years
Primary	Left ventricular diastolic function (E', E/E', A', E'/A', E-Wave, A-Wave, E/A)	Echocardiographic assessment, result in (cm/s)	Once every year over 3 years
Primary	Left ventricular systolic function (S', S)	Echocardiographic assessment, result in (cm/s)	Once every year over 3 years
Primary	Left Atrial Diameter and Right Atrial Diameter and Diameter/Body Surface Area	Echocardiographic assessment, result in (cm)	Once every year over 3 years
Primary	Left Atrial and Right Atrial Volume/Body Surface Area	Echocardiographic assessment, result in (ml/m²)	Once every year over 3 years
Primary	Left atrial peak longitudinal strain (L-PALS)	Echocardiographic assessment, result in (%)	Once every year over 3 years
Primary	Left atrial peak contraction strain (L-PACS)	Echocardiographic assessment, result in (%)	Once every year over 3 years
Primary	Left atrial total strain	Echocardiographic assessment, result in (%)	Once every year over 3 years
Primary	Right atrial peak longitudinal strain (R-PALS)	Echocardiographic assessment, result in (%)	Once every year over 3 years
Primary	Right atrial peak contraction strain (R-PACS)	Echocardiographic assessment, result in (%)	Once every year over 3 years
Primary	Global longitudinal strain (GLS)	Echocardiographic assessment, result in (%)	Once every year over 3 years
Primary	Intima-Media-Thickness (IMT)	Intima-Media-Thickness (IMT) of the A. carotis communis, sonographic assessment, result in (mm)	Once every year over 3 years
Primary	Peripheral and central pulse pressure	Assessment via blood pressure cuff, result in (mmHg)	Once every year over 3 years
Primary	Pulse Wave Velocity	Assessment via blood pressure cuff, result in (ms)	Once every year over 3 years
Secondary	Physical Fitness	Spiroergometric measure of VO2max	Once every year over 3 years
Secondary	Nutritional Status	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.	Once every year over 3 years
Secondary	Training Frequency	Assessment of training frequency via the MoMo activity questionnaire, result in (minutes/week)	Once every year over 3 years
Secondary	Medical history	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	Once every year over 3 years
Secondary	Height	Measured via Stadiometer, result in (cm)	Once every year over 3 years
Secondary	Weight	Measured on scale, result in (kg)	Once every year over 3 years
Secondary	Body-Mass-Index	Calculated from Heigt and Weight, result in (kg/m²)	Once every year over 3 years
Secondary	Bodyfat percentage	Measured via bioelectric impedance scale, result in (%)	Once every year over 3 years
Secondary	Fat mass	Measured via bioelectric impedance scale, result in (kg)	Once every year over 3 years
Secondary	Fat-free mass	Measured via bioelectric impedance scale, result in (kg)	Once every year over 3 years
Secondary	Muscle mass	Measured via bioelectric impedance scale, result in (kg)	Once every year over 3 years
Secondary	Water content	Measured via bioelectric impedance scale, result in (L)	Once every year over 3 years
Secondary	Waist circumference	Measured via measuring tape, result in (cm)	Once every year over 3 years
Secondary	Hip circumference	Measured via measuring tape, result in (cm)	Once every year over 3 years
Secondary	Sitting height (cm)	Measured via Stadiometer, result in (cm)	Once every year over 3 years
Secondary	Erythrocytes	Venous blood sampling and laboratory analysis, result in (/pL),	Once every year over 3 years
Secondary	GOT (AST)	Venous blood sampling and laboratory analysis, result in (U/L)	Once every year over 3 years
Secondary	GPT (ALT)	Venous blood sampling and laboratory analysis, result in (U/L)	Once every year over 3 years
Secondary	GGT	Venous blood sampling and laboratory analysis, result in (U/L)	Once every year over 3 years
Secondary	Cholesterol	Venous blood sampling and laboratory analysis, result in (mg/dL)	Once every year over 3 years
Secondary	HDL-Cholesterol	Venous blood sampling and laboratory analysis, result in (mg/dL)	Once every year over 3 years
Secondary	Non-HDL (calc.)	Venous blood sampling and laboratory analysis, result in (mg/dL)	Once every year over 3 years
Secondary	LDL-Cholesterol	Venous blood sampling and laboratory analysis, result in (mg/dL)	Once every year over 3 years
Secondary	Creatinine	Venous blood sampling and laboratory analysis, result in (mg/dL)	Once every year over 3 years
Secondary	Uric acid	Venous blood sampling and laboratory analysis, result in (mg/dL)	Once every year over 3 years
Secondary	hsCRP	Venous blood sampling and laboratory analysis, result in (mg/dL)	Once every year over 3 years
Secondary	fT3	Venous blood sampling and laboratory analysis, result in (pg/mL)	Once every year over 3 years
Secondary	Glutathion peroxidase	Venous blood sampling and laboratory analysis, result in (U/L)	Once every year over 3 years
Secondary	Superoxide dismutase	Venous blood sampling and laboratory analysis, result in (U/mL)	Once every year over 3 years
Secondary	Endothelin-1	Venous blood sampling, blood plasma preparation and laboratory analysis, result in (pg/mL)	Once every year over 3 years
Secondary	Nitric Oxide	Venous blood sampling, blood plasma preparation and laboratory analysis, result in (µmol/L)	Once every year over 3 years
Secondary	Ferritin	Venous blood sampling, blood plasma preparation and laboratory analysis, result in (ng/mL)	Once every year over 3 years
Secondary	Leptin	Venous blood sampling, blood plasma preparation and laboratory analysis, result in (ng/mL)	Once every year over 3 years
Secondary	Training intensity	Assessment of training intensity via the MoMo activity questionnaire, result in (metabolic equivalent task-minutes/week)	Once every year over 3 years
Secondary	Hemoglobin	Venous blood sampling and laboratory analysis, result in (g/dL)	Once every year over 3 years
Secondary	HBE/MCH	Venous blood sampling and laboratory analysis, result in (pg)	Once every year over 3 years
Secondary	MCV	Venous blood sampling and laboratory analysis, result in (fL)	Once every year over 3 years
Secondary	Hematocrit	Venous blood sampling and laboratory analysis, result in (%)	Once every year over 3 years
Secondary	MCHC	Venous blood sampling and laboratory analysis, result in (g/dL)	Once every year over 3 years
Secondary	RDW (Ery)	Venous blood sampling and laboratory analysis, result in (%)	Once every year over 3 years
Secondary	Thrombocytes	Venous blood sampling and laboratory analysis, result in (Tsnd/µL)	Once every year over 3 years
Secondary	Leukocytes	Venous blood sampling and laboratory analysis, result in (/nL)	Once every year over 3 years
Secondary	Heart Rate	Assessment via blood pressure cuff, result in (bpm)	Once every year over 3 years