- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03304483
Cardiovascular Responses to Spartathlon Running (Spartathlon)
July 19, 2023 updated by: Evangelia Kouidi, Aristotle University Of Thessaloniki
Cardiovascular Effects of Ultramarathon Running
The aim of this study is to examine the cardiovascular effects of ultramarathon running and their relation to performance.
Study Overview
Detailed Description
The purpose of the study is to determine the changes of cardiovascular morphology and function after an ultramarathon race.
50 entrants to the "Spartathlon 2017" 246-km running race will participate in the study.
Cardiac and arterial morphology and function tests will be conducted one day before the race and within 20 minutes of race completion.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Thessaloniki, Greece, 546 35
- Laboratory of Sports Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 67 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Runners at least 18 years old, healthy and sufficiently trained.
- Runners being accepted to participate in the Spartathlon race according to the eligibility criteria (http://www.spartathlon.gr/en/registration-en.html)
- Runners who will volunteer to be examined pre- and post the race
Exclusion Criteria:
- Runners with chronic diseases
- Runners receiving any medication
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Athletes
246-km running
|
Spartathlon 2017
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of right ventricular function after one day ultra-marathon running
Time Frame: before and after 1 day running
|
Echocardiographic study of left ventricular function
|
before and after 1 day running
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of left ventricular function after one day ultra-marathon running
Time Frame: before and after 1 day running
|
Echocardiographic study of left ventricular function
|
before and after 1 day running
|
|
Change of carotid artery function after one day ultra-marathon running
Time Frame: before and after 1 day running
|
Echocardiographic study of carotid arteries
|
before and after 1 day running
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Evangelia Kouidi, Professor, Aristotle University of Thessaloniki, Greece
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Seedhouse EL, Walsh ML, Blaber AP. Heart rate, mean arterial blood pressure, and pulmonary function changes associated with an ultraendurance triathlon. Wilderness Environ Med. 2006 Winter;17(4):240-5. doi: 10.1580/pr27-05-r1.1.
- Millet GP, Millet GY. Ultramarathon is an outstanding model for the study of adaptive responses to extreme load and stress. BMC Med. 2012 Jul 19;10:77. doi: 10.1186/1741-7015-10-77.
- Cote AT, Phillips AA, Foulds HJ, Charlesworth SA, Bredin SS, Burr JF, Koehle MS, Warburton DE. Sex differences in cardiac function after prolonged strenuous exercise. Clin J Sport Med. 2015 May;25(3):276-83. doi: 10.1097/JSM.0000000000000130.
- Jee H, Park J, Oh JG, Lee YH, Shin KA, Kim YJ. Effect of a prolonged endurance marathon on vascular endothelial and inflammation markers in runners with exercise-induced hypertension. Am J Phys Med Rehabil. 2013 Jun;92(6):513-22. doi: 10.1097/PHM.0b013e31829232db.
- Blaber AP, Walsh ML, Carter JB, Seedhouse EL, Walker VE. Cardiopulmonary physiology and responses of ultramarathon athletes to prolonged exercise. Can J Appl Physiol. 2004 Oct;29(5):544-63. doi: 10.1139/h04-035.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 29, 2017
Primary Completion (Actual)
December 30, 2019
Study Completion (Actual)
June 30, 2021
Study Registration Dates
First Submitted
September 28, 2017
First Submitted That Met QC Criteria
October 6, 2017
First Posted (Actual)
October 9, 2017
Study Record Updates
Last Update Posted (Actual)
July 20, 2023
Last Update Submitted That Met QC Criteria
July 19, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 84542
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
No personal details will be shared.
Only the results of the measurements will be available
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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