The Munich Cardiovascular Adaptation in Young Athletes Plus Study

NCT06259617 | Recruiting

• 1 other identifier: 516547656
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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?

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

Outcome Measures

Primary Outcomes (22)

• Vascular stiffness

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

  Once every year over 3 years

• Peripheral and central blood pressure

  Assessment via blood pressure cuff, result in (mmHg) Pulse Wave Velocity

  Once every year over 3 years

• Left Ventricular internal end diastolic diameter (LVIDd)

  Echocardiographic assessment, result in (mm)

  Once every year over 3 years

• Left ventricular posterior wall end diastole (LVPWd)

  Echocardiographic assessment, result in (mm)

  Once every year over 3 years

• Interventricular septum thickness (IVSd)

  Echocardiographic assessment, result in (mm)

  Once every year over 3 years

• Left ventricular mass (LVM)

  Echocardiographic assessment, result in (g)

  Once every year over 3 years

• Relative wall thickness (RWT)

  Echocardiographic assessment, result in (mm)

  Once every year over 3 years

• Ejection fraction (EF)

  Echocardiographic assessment, result in (%)

  Once every year over 3 years

• Fractional shortening (FS)

  Echocardiographic assessment, result in (%)

  Once every year over 3 years

• 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

• Left ventricular systolic function (S', S)

  Echocardiographic assessment, result in (cm/s)

  Once every year over 3 years

• Left Atrial Diameter and Right Atrial Diameter and Diameter/Body Surface Area

  Echocardiographic assessment, result in (cm)

  Once every year over 3 years

• Left Atrial and Right Atrial Volume/Body Surface Area

  Echocardiographic assessment, result in (ml/m²)

  Once every year over 3 years

• Left atrial peak longitudinal strain (L-PALS)

  Echocardiographic assessment, result in (%)

  Once every year over 3 years

• Left atrial peak contraction strain (L-PACS)

  Echocardiographic assessment, result in (%)

  Once every year over 3 years

• Left atrial total strain

  Echocardiographic assessment, result in (%)

  Once every year over 3 years

• Right atrial peak longitudinal strain (R-PALS)

  Echocardiographic assessment, result in (%)

  Once every year over 3 years

• Right atrial peak contraction strain (R-PACS)

  Echocardiographic assessment, result in (%)

  Once every year over 3 years

• Global longitudinal strain (GLS)

  Echocardiographic assessment, result in (%)

  Once every year over 3 years

• Intima-Media-Thickness (IMT)

  Intima-Media-Thickness (IMT) of the A. carotis communis, sonographic assessment, result in (mm)

  Once every year over 3 years

• Peripheral and central pulse pressure

  Assessment via blood pressure cuff, result in (mmHg)

  Once every year over 3 years

• Pulse Wave Velocity

  Assessment via blood pressure cuff, result in (ms)

  Once every year over 3 years

Secondary Outcomes (43)

• Physical Fitness

  Once every year over 3 years

• Nutritional Status

  Once every year over 3 years

• Training Frequency

  Once every year over 3 years

• Medical history

  Once every year over 3 years

• Height

  Once every year over 3 years

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Presence of an acute infection, acute orthopedic injury, or chronic disease
• Missing consent from the participant and/or legal guardian

Sponsors & Collaborators

• Technical University of Munich: lead
• German Research Foundation: collaborator

Study Sites (1)

Sportmedizinische Ambulanz für Kinder und Jugendliche

München, Bavaria, 80992, Germany

RECRUITING

Related 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.

  PMID: 31649936 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood, Serum, Blood Plasma

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Thorsten Schulz, Dr.

  Technical University of Munich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tobias Engl, Dipl. Sportwiss. Univ.

CONTACT

+49 89 289 24598; tobias.engl@tum.de

Jonas Haferanke, M.Sc.

CONTACT

+49 89 289 24579; jonas.haferanke@tum.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 14, 2024
• Study Start: December 1, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 14, 2024

Record last verified: 2024-02

Locations

DE (1)