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Идёт набор NCT06259617

The Munich Cardiovascular Adaptation in Young Athletes Plus Study

— Наблюдательное Exercise

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Exercise. Базовые параметры: 7 лет — 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Германия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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)

Обзор

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?

Первичные конечные точки

  • Vascular stiffness [Срок оценки: Once every year over 3 years]
  • Peripheral and central blood pressure [Срок оценки: Once every year over 3 years]
  • Left Ventricular internal end diastolic diameter (LVIDd) [Срок оценки: Once every year over 3 years]
  • Left ventricular posterior wall end diastole (LVPWd) [Срок оценки: Once every year over 3 years]
  • Interventricular septum thickness (IVSd) [Срок оценки: Once every year over 3 years]
  • Left ventricular mass (LVM) [Срок оценки: Once every year over 3 years]
  • Relative wall thickness (RWT) [Срок оценки: Once every year over 3 years]
  • Ejection fraction (EF) [Срок оценки: Once every year over 3 years]
  • Fractional shortening (FS) [Срок оценки: Once every year over 3 years]
  • Left ventricular diastolic function (E', E/E', A', E'/A', E-Wave, A-Wave, E/A) [Срок оценки: Once every year over 3 years]
Вторичные конечные точки (12)
  • Physical Fitness [Срок оценки: Once every year over 3 years]
  • Nutritional Status [Срок оценки: Once every year over 3 years]
  • Training Frequency [Срок оценки: Once every year over 3 years]
  • Medical history [Срок оценки: Once every year over 3 years]
  • Height [Срок оценки: Once every year over 3 years]
  • Weight [Срок оценки: Once every year over 3 years]
  • Body-Mass-Index [Срок оценки: Once every year over 3 years]
  • Bodyfat percentage [Срок оценки: Once every year over 3 years]
  • Fat mass [Срок оценки: Once every year over 3 years]
  • Fat-free mass [Срок оценки: Once every year over 3 years]
  • Muscle mass [Срок оценки: Once every year over 3 years]
  • Water content [Срок оценки: Once every year over 3 years]

Критерии участия

Критерии включения

  • 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Германия · 1 центр
  • Sportmedizinische Ambulanz für Kinder und Jugendliche — München

Публикации

  • 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

Идентификаторы

NCT: NCT06259617 · 516547656

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗