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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

France1 site
  • CHU de Saint-Etienne

    Saint-Etienne, 42000

Other trials in France

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.

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 groups in NCT01602146
Study groupRoleWhat they receive
ultramarathon runnerPeople 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.

  1. central fatigue

    quantify supraspinal central fatigue

    Measured: Immediatly after the Mont Blanc ultramarathon

Secondary outcomes (3)
  1. 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

  2. kidney consequences

    Evaluate, by biological urine and blood samples, the consequences of a mountain ultramarathon on kidneys

    Measured: Immediatly after the Mont Blanc ultramarathon

  3. 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.

  1. First posted18 May 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionSep 2012
  4. Study completionSep 2012

Resources

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)
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

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.

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