NCT04738877

Brief Summary

The aim of this study is the investigation of acute cardiovascular responses of marathon runners after the completion of a marathon race (42.2 km), as well as of the determinants of these changes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

February 2, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

November 15, 2023

Status Verified

November 1, 2023

Enrollment Period

7 months

First QC Date

January 27, 2021

Last Update Submit

November 14, 2023

Conditions

Outcome Measures

Primary Outcomes (8)

  • Baseline left ventricular (LV) systolic function

    Evaluation of LV ejection fraction

    Evaluation of athletes within 3 weeks before the marathon running race.

  • Baseline LV diastolic function

    Evaluation of LV filling pressures

    Evaluation of athletes within 3 weeks before the marathon running race.

  • Baseline basal right ventricular (RV) function

    Evaluation of tricuspid annular plane systolic excursion (TAPSE)

    Evaluation of athletes within 3 weeks before the marathon running race.

  • Baseline global RV function

    Evaluation of RV fractional are change (RVFAC)

    Evaluation of athletes within 3 weeks before the marathon running race.

  • Post-exercise LV systolic function

    Evaluation of LV ejection fraction

    Evaluation of athletes immediately after the completion of the marathon running race.

  • Post-exercise LV diastolic function

    Evaluation of LV filling pressures

    Evaluation of athletes immediately after the completion of the marathon running race.

  • Post-exercise basal RV function

    Evaluation of TAPSE

    Evaluation of athletes immediately after the completion of the marathon running race.

  • Post-exercise global RV function

    Evaluation of RVFAC

    Evaluation of athletes immediately after the completion of the marathon running race.

Interventions

Body fat measurementDIAGNOSTIC_TEST

Body fat measurement using skinfolds

Electrocardiographic exercise testing with ergospirometer on a treadmill

EchocardiographyDIAGNOSTIC_TEST

Transthoracic echocardiography

Blood testDIAGNOSTIC_TEST

Blood test for measurement of haemoglobin, serum electrolytes, iron, ferritin and vitamins

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Marathon runners aiming to paricipate in a marathon running race

You may qualify if:

  • Marathon runner

You may not qualify if:

  • Chronic disease, Drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aristotle University of Thessaloniki

Thessaloniki, Greece

Location

Related Publications (1)

  • Christou GA, Pagourelias ED, Deligiannis AP, Kouidi EJ. Exploring the Anthropometric, Cardiorespiratory, and Haematological Determinants of Marathon Performance. Front Physiol. 2021 Sep 3;12:693733. doi: 10.3389/fphys.2021.693733. eCollection 2021.

MeSH Terms

Interventions

Exercise TestEchocardiographyHematologic Tests

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative TechniquesCardiac Imaging TechniquesDiagnostic ImagingUltrasonographyClinical Laboratory Techniques

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Sports Medicine

Study Record Dates

First Submitted

January 27, 2021

First Posted

February 4, 2021

Study Start

February 2, 2021

Primary Completion

August 30, 2021

Study Completion

August 30, 2021

Last Updated

November 15, 2023

Record last verified: 2023-11

Locations