Clinical trial NCT04166903: Prospective Follow-up, Marathon, Long Term, Inflammation and Cardiovascular System
Official title: Prospective Long Term Follow-up Analysis of Exercise-induced Physiological Changes in Male Runners
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Participants of the Be-MaGIC-Study 2009
Keywords: Prolonged exercise, marathon, cardiovascular disease, long term
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: Balgrist University Hospital
name: Deutsches Herzzentrum Muenchen
First posted: 2019-11-18
Enrollment: 277
Sex: MALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants of the Be-MaGIC-Study (2009)

Brief summary: Pro-MagIC is a prospective observational study and includes participants of the Be-MaGIC-Study 2009 (n=277/NCT00933218). We aim to detect exercise-induced physiological changes (inter alia of the cardiovascular system) induced by repetitive ultra-endurance strain over a period of 10 years.

Detailed description: Physical activity is associated with health benefits. Acute prolonged and strenuous exercise, i.e. Marathon running, leads to hemodynamic, endothelial and myocardial functional changes. Whether these myocardial, endothelial and hemodynamic changes can also develop and persist through repetitive extreme and prolonged physical activity is currently still a matter of controversy. In addition, it is not known whether adaptations and changes over time can develop into clinically relevant cardiovascular events with negative health consequences in healthy athletes. The aim of this study is to detect exercise-induced physiological changes (inter alia of the cardiovascular system) induced by repetitive ultra-endurance strain over a period of 10 years.

For this purpose, 277 male participants from the Be-MaGIC study (Marathon 2009) are examined in this prospective observational study. A single examination with the following components will take place: Anthropometry, clinical examination, laboratory, resting / exercise electrocardiography cardiopulmonary stress test, echocardiography, and fundus camera. Further examinations will be conducted in participants with abnormal examination results in line with current clinical recommendations.

Eligibility criteria: Inclusion Criteria:

Declaration of consent Participants must have participated in the Be-MaGIC study in 2009

* current age: 30 - 70 years
* sex: male

Exclusion Criteria:

-

Primary outcomes:
measure: Changes of right ventricular systolic function (RV-EF)
timeFrame: 10 years
Secondary outcomes:
measure: Changes in left ventricular ejection fraction (LV-EF)
timeFrame: 10 years
measure: Changes in left ventricular diastolic function (E/e´)
timeFrame: 10 years
measure: Change in cardiac markers (e.g. cardiac Troponin)
timeFrame: 10 years
measure: Change in inflammation markers (e.g. C-reactive Protein)
timeFrame: 10 years
measure: Change in microcirculation (e.g. arteriolar-to-venular ratio)
timeFrame: 10 years
measure: Change in macrocirculation (e.g. Intima media thickness)
timeFrame: 10 years
measure: Change of prevalence of cardiovascular diseases
timeFrame: 10 years
measure: Association between changes of aforementioned parameters (see Topics 1-8) and potential underlying causes (e.g. sports history like number of ultraendurance competitions) in the examined cohort
timeFrame: 10 years
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Prevention, Rehabilitation and Sports Medicine, Munich, Germany
state: Bavaria
Study officials:
affiliation: Department of Prevention, Rehabilitation and Sports Medicine, Munich, Germany
name: Michael Schindler, MD
role: STUDY_DIRECTOR
affiliation: University Hospital Balgrist, University Zurich, Switzerland
name: Johannes Scherr, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Prevention, Rehabilitation and Sports Medicine, Munich, Germany
name: Martin Halle, MD
role: STUDY_DIRECTOR
References:
citation: Schoenfeld J, Schindler MJ, Haller B, Holdenrieder S, Nieman DC, Halle M, La Gerche A, Scherr J. Prospective long-term follow-up analysis of the cardiovascular system in marathon runners: study design of the Pro-MagIC study. BMJ Open Sport Exerc Med. 2020 Jul 19;6(1):e000786. doi: 10.1136/bmjsem-2020-000786. eCollection 2020.