Ultramarathon RunnerCHAMONIX2NCT01602146
Problems Associated With Ultramarathon
An observational study of Ultramarathon Runner, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Acute physiological consequences of ultramarathon running are still unknown, particularly in women. Results from the investigators first studies conducted in 2009 have shown that a large part of fatigue induced by a mountain ultramarathon could be attributed to central fatigue. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Ultramarathon Runner
- What is being tested?
- ultramarathon running
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2012to Sep 2012
- Phase
- Observational
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: ultramarathon runner
Who may be able to join
- participating to Mont-Blanc ultramarathon
- participation in at least two ultra-endurance races like Trail
Who cannot join
- injury within 3 months before the race
- joint pathology
- contra indication for magnetic stimulation transcranial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute and Chronic Problems Associated With the Practice of Mountain Ultramarathon
Acute physiological consequences of ultramarathon running are still unknown, particularly in women. Results from the investigators first studies conducted in 2009 have shown that a large part of fatigue induced by a mountain ultramarathon could be attributed to central fatigue. The investigators have investigated the biological consequences and neuromuscular fatigue only in male runners. Data from the literature suggest that amplitude and etiology of fatigue after prolonged exercise might be gender-dependant.The main purpose of the present project is thus to quantify supraspinal central fatigue and associated changes in cortical excitability after an extreme exercise such as a mountain ultramarathon: the Ultra-Trail du Mont-blanc, by using TMS.
Read the detailed description
Acute physiological consequences of ultramarathon running are still unknown, particularly in women. Results from our first studies conducted in 2009 have shown that a large part of fatigue induced by a mountain ultramarathon could be attributed to central fatigue. Indeed, during extreme exercises such as 24h running, strength losses of knee extensor muscles have reached -40% and ¾ of this fatigue was explain by a central deficit while peripheral mechanisms explained only ¼. Similar results have been reported after a mountain ultramarathon despite the fact that several downhill have induced number of eccentric contractions. As a consequence, central fatigue must be particularly investigated. For this purpose, transcranial magnetic stimulation (TMS) has been recently validated to measure supraspinal central fatigue and cortical excitability.
We have investigated the biological consequences and neuromuscular fatigue only in male runners. Data from the literature suggest that amplitude and etiology of fatigue after prolonged exercise might be gender-dependant. However, these physiological data and studies that have paired male and female by level of performance on shorter distances seem contradictory with performance comparison between genders so that the relative superiority of women in ultra-endurance is not ascertained. The hypothesis of a greater fatigue resistance after ultramarathons in women should then be tested. The biological consequences of ultramarathon are far to be negligible in terms of inflammatory syndrome but complete characterization of this syndrome after such an extreme exercise has yet to be done. Also, several cases of renal failure have been reported after ultramarathons. Evaluation of ultramarathon consequences on kidneys is necessary to prevent serious complications. Finally, consequences of an ultramarathon are not only linked to races but also to training, i.e. the prolonged time spent in running to prepare for the races. Energy expenditure can be more than twice the normal one and repeated impact may potentially alter bone metabolism but to the best of our knowledge, there is no study that have assessed the effects of ultra-endurance running on bone tissue, particularly in males.
The main purpose of the present project is thus to quantify supraspinal central fatigue and associated changes in cortical excitability after an extreme exercise such as a mountain ultramarathon: the Ultra-Trail du Mont-blanc, by using TMS. The secondary purpose are (i) to compare neuromuscular and biological alterations induced by a mountain ultramarathon between males and females matched by age and level of performance, (ii) to evaluate, by biological urine and blood samples, the consequences of a mountain ultramarathon on kidneys and (iii) to investigate the hormonal status and bone mineral density of a group of male and female runners who take part to this type of event regularly.
- Conditions
- Ultramarathon Runner
- Being tested
- ultramarathon running
- Keywords
- ultramarathon central fatigue,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultramarathon runningOther
- blood samples before and after ultramarathon
- urinary samples before and after ultramarathon
- voluntary ant electrically muscular forces measuring before and after ultramarathon
- Broadband ultrasound Attenuation before and after ultramarathon
| Study group | Role | What they receive |
|---|---|---|
| ultramarathon runner | People who do the Mont Blanc ultramarathon (31/08/12 to 02/09/12) Receives: Other: ultramarathon running |
What is being measured
The primary outcome is the main question the study is designed to answer.
central fatigue
quantify supraspinal central fatigue
Measured: Immediatly after the Mont Blanc ultramarathon
Secondary outcomes (3)
neuromuscular and biological alterations
compare neuromuscular and biological alterations induced by a mountain ultramarathon between males and females matched by age and level of performance
Measured: Immediatly after the Mont Blanc ultramarathon
kidney consequences
Evaluate, by biological urine and blood samples, the consequences of a mountain ultramarathon on kidneys
Measured: Immediatly after the Mont Blanc ultramarathon
hormonal status and bone mineral density
investigate the hormonal status and bone mineral density of a group of male and female runners who take part to this type of event regularly
Measured: Immediatly after the Mont Blanc ultramarathon
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2012 (estimated)
- Study startJun 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultramarathon RunnerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leonard FEASSON, MD, Principal investigator, Centre Hospitalier Universitaire de Saint EtienneGuillaume MILLET, PhD, Study chair, Université de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01602146
- Sponsor's protocol ID
- 1208048
- Other IDs
- 2012-A00424-39
- Acronym
- CHAMONIX2
- Status last verified
- Nov 2012
- First submitted
- 2 May 2012
- Last updated
- 12 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute and Chronic Problems Associated With the Practice of Mountain Ultramarathon
- ClinicalTrials.gov ID
- NCT01602146
- Acronym / sponsor ID
- CHAMONIX2 / 1208048
- Conditions
- Ultramarathon Runner
- Keywords
- ultramarathon central fatigue,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 18 May 2012 (estimated)
- 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.
Acute physiological consequences of ultramarathon running are still unknown, particularly in women. Results from the investigators first studies conducted in 2009 have shown that a large part of fatigue induced by a mountain ultramarathon could be attributed to central fatigue. The investigators have investigated the biological consequences and neuromuscular fatigue only in male runners. Data from the literature suggest that amplitude and etiology of fatigue after prolonged exercise might be gender-dependant.The main purpose of the present project is thus to quantify supraspinal central fatigue and associated changes in cortical excitability after an extreme exercise such as a mountain ultramarathon: the Ultra-Trail du Mont-blanc, by using TMS.
Detailed description
Acute physiological consequences of ultramarathon running are still unknown, particularly in women. Results from our first studies conducted in 2009 have shown that a large part of fatigue induced by a mountain ultramarathon could be attributed to central fatigue. Indeed, during extreme exercises such as 24h running, strength losses of knee extensor muscles have reached -40% and ¾ of this fatigue was explain by a central deficit while peripheral mechanisms explained only ¼. Similar results have been reported after a mountain ultramarathon despite the fact that several downhill have induced number of eccentric contractions. As a consequence, central fatigue must be particularly investigated. For this purpose, transcranial magnetic stimulation (TMS) has been recently validated to measure supraspinal central fatigue and cortical excitability.
We have investigated the biological consequences and neuromuscular fatigue only in male runners. Data from the literature suggest that amplitude and etiology of fatigue after prolonged exercise might be gender-dependant. However, these physiological data and studies that have paired male and female by level of performance on shorter distances seem contradictory with performance comparison between genders so that the relative superiority of women in ultra-endurance is not ascertained. The hypothesis of a greater fatigue resistance after ultramarathons in women should then be tested. The biological consequences of ultramarathon are far to be negligible in terms of inflammatory syndrome but complete characterization of this syndrome after such an extreme exercise has yet to be done. Also, several cases of renal failure have been reported after ultramarathons. Evaluation of ultramarathon consequences on kidneys is necessary to prevent serious complications. Finally, consequences of an ultramarathon are not only linked to races but also to training, i.e. the prolonged time spent in running to prepare for the races. Energy expenditure can be more than twice the normal one and repeated impact may potentially alter bone metabolism but to the best of our knowledge, there is no study that have assessed the effects of ultra-endurance running on bone tissue, particularly in males.
The main purpose of the present project is thus to quantify supraspinal central fatigue and associated changes in cortical excitability after an extreme exercise such as a mountain ultramarathon: the Ultra-Trail du Mont-blanc, by using TMS. The secondary purpose are (i) to compare neuromuscular and biological alterations induced by a mountain ultramarathon between males and females matched by age and level of performance, (ii) to evaluate, by biological urine and blood samples, the consequences of a mountain ultramarathon on kidneys and (iii) to investigate the hormonal status and bone mineral density of a group of male and female runners who take part to this type of event regularly.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ultramarathon runner | – | Other: ultramarathon runningPeople who do the Mont Blanc ultramarathon (31/08/12 to 02/09/12) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- ultramarathon runner
Key inclusion criteria (2 listed)
- participating to Mont-Blanc ultramarathon
- participation in at least two ultra-endurance races like Trail
Key exclusion criteria (3 listed)
- injury within 3 months before the race
- joint pathology
- contra indication for magnetic stimulation transcranial
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 |
|---|---|---|
| ultramarathon running* blood samples before and after ultramarathon * urinary samples before and after ultramarathon * voluntary ant electrically muscular forces measuring before and after ultramarathon * Broadband ultrasound Attenuation before and after ultramarathon | Other | ultramarathon runner |
Primary outcome
central fatigue
Time frame: Immediatly after the Mont Blanc ultramarathon
quantify supraspinal central fatigue
3 secondary outcomes
neuromuscular and biological alterations
Time frame: Immediatly after the Mont Blanc ultramarathon
kidney consequences
Time frame: Immediatly after the Mont Blanc ultramarathon
hormonal status and bone mineral density
Time frame: Immediatly after the Mont Blanc ultramarathon
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 12 Nov 2012.
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.
Leonard FEASSON, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
Guillaume MILLET, PhD study chair
Université de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultramarathon Runner, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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 2 inclusion and 3 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 12 Nov 2012. 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 France. 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?
central fatigue (time frame: Immediatly after the Mont Blanc ultramarathon). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Nov 2012.