Disorder HeartSpartathlonNCT03304483
Cardiovascular Responses to Spartathlon Running
A study testing 246-km running in people with Disorder Heart, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
The aim of this study is to examine the cardiovascular effects of ultramarathon running and their relation to performance. Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Disorder Heart
- What is being tested?
- 246-km running
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGreece
- Study dates
- 29 Sep 2017to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Runners with chronic diseases
- Runners receiving any medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiovascular Effects of Ultramarathon Running
The aim of this study is to examine the cardiovascular effects of ultramarathon running and their relation to performance.
Read the 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.
- Conditions
- Disorder Heart
- Being tested
- 246-km running
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
246-km runningOther
Spartathlon 2017
| Study group | Role | What they receive |
|---|---|---|
| Athletes | Experimental | 246-km running Receives: Other: 246-km running |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of right ventricular function after one day ultra-marathon running
Echocardiographic study of left ventricular function
Measured: before and after 1 day running
Secondary outcomes (2)
Change of left ventricular function after one day ultra-marathon running
Echocardiographic study of left ventricular function
Measured: before and after 1 day running
Change of carotid artery function after one day ultra-marathon running
Echocardiographic study of carotid arteries
Measured: before and after 1 day running
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2017
- Study start29 Sep 2017
- Primary completion30 Dec 2019
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Disorder HeartStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- athletes participating in the ultra marathon running
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evangelia Kouidi, Aristotle University Of Thessaloniki
- Investigators
- Evangelia Kouidi, Professor, Principal investigator, Aristotle University of Thessaloniki, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03304483
- Sponsor's protocol ID
- 84542
- Acronym
- Spartathlon
- Status last verified
- Jul 2023
- First submitted
- 28 Sep 2017
- Last updated
- 20 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No personal details will be shared. Only the results of the measurements will be available
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.
PubMed 17219787Millet 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.
PubMed 22812424Cote 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.
PubMed 25010150Jee 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.
PubMed 23685440Blaber 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.
PubMed 15507692
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Effects of Ultramarathon Running
- ClinicalTrials.gov ID
- NCT03304483
- Acronym / sponsor ID
- Spartathlon / 84542
- Conditions
- Disorder Heart
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 29 Sep 2017 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 9 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to examine the cardiovascular effects of ultramarathon running and their relation to performance.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- athletes participating in the ultra marathon running
| Arm | Type | Receives |
|---|---|---|
| Athletes | Experimental | Other: 246-km running246-km running |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Runners with chronic diseases
- Runners receiving any medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 246-km runningSpartathlon 2017 | Other | Athletes |
Primary outcome
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
2 secondary outcomes
Change of left ventricular function after one day ultra-marathon running
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Background: PubMed 17219787Seedhouse 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.
- Background: PubMed 22812424Millet 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.
- Background: PubMed 25010150Cote 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.
- Background: PubMed 23685440Jee 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.
- Results publication: PubMed 15507692Blaber 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.
- Individual participant dataSharing planned: No. No personal details will be shared. Only the results of the measurements will be available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evangelia Kouidi, Professor principal investigator
Aristotle University of Thessaloniki, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 246-km running in people with Disorder Heart, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of right ventricular function after one day ultra-marathon running (time frame: before and after 1 day running). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03304483, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.