Clinical trial NCT06259617: The Munich Cardiovascular Adaptation in Young Athletes Plus Study
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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Exercise
Keywords: Adolescents
Children
Exercise
Physical Activity
Vascular adaptation
Cardial adaptation
Carotid Intima-Media-Thickness
Pulse Wave Velocity
Blood pressure
Athletic performance
Nutritional status
Body composition
Biomarkers
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2024-02-14
Enrollment: 250
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants aged ≥7 and \<18 years, which are participating in athletic competitions, engage in regular training in a primary sport and are members of a club and/or association, with a training load of ≥3 hours per week The participants are recruited at the Pediatric Sports Medicine Outpatient Clinic at the Chair of Preventive Pediatrics. Children and adolescents voluntarily present themselves for sports fitness examinations, either for their competitive activities or as a requirement. These include young athletes who have been examined in previous years or those undergoing a sports fitness examination for the first time.

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?


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

Primary outcomes:
measure: Vascular stiffness
timeFrame: Once every year over 3 years
measure: Peripheral and central blood pressure
timeFrame: Once every year over 3 years
measure: Left Ventricular internal end diastolic diameter (LVIDd)
timeFrame: Once every year over 3 years
measure: Left ventricular posterior wall end diastole (LVPWd)
timeFrame: Once every year over 3 years
measure: Interventricular septum thickness (IVSd)
timeFrame: Once every year over 3 years
measure: Left ventricular mass (LVM)
timeFrame: Once every year over 3 years
measure: Relative wall thickness (RWT)
timeFrame: Once every year over 3 years
measure: Ejection fraction (EF)
timeFrame: Once every year over 3 years
measure: Fractional shortening (FS)
timeFrame: Once every year over 3 years
measure: Left ventricular diastolic function (E', E/E', A', E'/A', E-Wave, A-Wave, E/A)
timeFrame: Once every year over 3 years
measure: Left ventricular systolic function (S', S)
timeFrame: Once every year over 3 years
measure: Left Atrial Diameter and Right Atrial Diameter and Diameter/Body Surface Area
timeFrame: Once every year over 3 years
measure: Left Atrial and Right Atrial Volume/Body Surface Area
timeFrame: Once every year over 3 years
measure: Left atrial peak longitudinal strain (L-PALS)
timeFrame: Once every year over 3 years
measure: Left atrial peak contraction strain (L-PACS)
timeFrame: Once every year over 3 years
measure: Left atrial total strain
timeFrame: Once every year over 3 years
measure: Right atrial peak longitudinal strain (R-PALS)
timeFrame: Once every year over 3 years
measure: Right atrial peak contraction strain (R-PACS)
timeFrame: Once every year over 3 years
measure: Global longitudinal strain (GLS)
timeFrame: Once every year over 3 years
measure: Intima-Media-Thickness (IMT)
timeFrame: Once every year over 3 years
measure: Peripheral and central pulse pressure
timeFrame: Once every year over 3 years
measure: Pulse Wave Velocity
timeFrame: Once every year over 3 years
Secondary outcomes:
measure: Physical Fitness
timeFrame: Once every year over 3 years
measure: Nutritional Status
timeFrame: Once every year over 3 years
measure: Training Frequency
timeFrame: Once every year over 3 years
measure: Medical history
timeFrame: Once every year over 3 years
measure: Height
timeFrame: Once every year over 3 years
measure: Weight
timeFrame: Once every year over 3 years
measure: Body-Mass-Index
timeFrame: Once every year over 3 years
measure: Bodyfat percentage
timeFrame: Once every year over 3 years
measure: Fat mass
timeFrame: Once every year over 3 years
measure: Fat-free mass
timeFrame: Once every year over 3 years
measure: Muscle mass
timeFrame: Once every year over 3 years
measure: Water content
timeFrame: Once every year over 3 years
measure: Waist circumference
timeFrame: Once every year over 3 years
measure: Hip circumference
timeFrame: Once every year over 3 years
measure: Sitting height (cm)
timeFrame: Once every year over 3 years
measure: Erythrocytes
timeFrame: Once every year over 3 years
measure: GOT (AST)
timeFrame: Once every year over 3 years
measure: GPT (ALT)
timeFrame: Once every year over 3 years
measure: GGT
timeFrame: Once every year over 3 years
measure: Cholesterol
timeFrame: Once every year over 3 years
measure: HDL-Cholesterol
timeFrame: Once every year over 3 years
measure: Non-HDL (calc.)
timeFrame: Once every year over 3 years
measure: LDL-Cholesterol
timeFrame: Once every year over 3 years
measure: Creatinine
timeFrame: Once every year over 3 years
measure: Uric acid
timeFrame: Once every year over 3 years
measure: hsCRP
timeFrame: Once every year over 3 years
measure: fT3
timeFrame: Once every year over 3 years
measure: Glutathion peroxidase
timeFrame: Once every year over 3 years
measure: Superoxide dismutase
timeFrame: Once every year over 3 years
measure: Endothelin-1
timeFrame: Once every year over 3 years
measure: Nitric Oxide
timeFrame: Once every year over 3 years
measure: Ferritin
timeFrame: Once every year over 3 years
measure: Leptin
timeFrame: Once every year over 3 years
measure: Training intensity
timeFrame: Once every year over 3 years
measure: Hemoglobin
timeFrame: Once every year over 3 years
measure: HBE/MCH
timeFrame: Once every year over 3 years
measure: MCV
timeFrame: Once every year over 3 years
measure: Hematocrit
timeFrame: Once every year over 3 years
measure: MCHC
timeFrame: Once every year over 3 years
measure: RDW (Ery)
timeFrame: Once every year over 3 years
measure: Thrombocytes
timeFrame: Once every year over 3 years
measure: Leukocytes
timeFrame: Once every year over 3 years
measure: Heart Rate
timeFrame: Once every year over 3 years
Other outcomes:
Locations:
city: München
country: Germany
facility: Sportmedizinische Ambulanz für Kinder und Jugendliche
state: Bavaria
Study officials:
affiliation: Technical University of Munich
name: Thorsten Schulz, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.