Sports MedicineUT4M2020NCT04545216
Impact of Long Distance Mountain Race on Knee Cartilage.
An observational study of Sports Medicine, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Long-distance mountain running is increasingly popular among European and North America countries. Long-distance races are organized in various mountains and can reach up to 160 km (100 miles) with several thousands meters of climbing. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sports Medicine
- What is being tested?
- Long-distance mountain running
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- 3 Sep 2020to 31 Dec 2021
- 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
- Men only
- Healthy volunteers accepted
- Adult
Study population: Healthy male runners
Who may be able to join
- no cardiac, respiratory or neuromuscular diseases
- more than 2 years of experience in mountain race
- no contre-indication for participating in a mountain race
Who cannot join
- history of knee surgery
- contre-indication to MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Impact of an Ultratrail on the Knee Cartilage by Using T2 MRI: a Pilot Study
Long-distance mountain running is increasingly popular among European and North America countries. Long-distance races are organized in various mountains and can reach up to 160 km (100 miles) with several thousands meters of climbing. The pathophysiological consequences of such extreme effort is still a matter a debate. From a muskelo-skeletal perspectives, the potential lower-limb join damage is a major health issue. The present study aims to use objective magnetic resonance imaging (MRI) techniques to describe the consequences of performing long-distance mountain running races on the knee cartilage.
Read the detailed description
Healthy male runners will perform T2 MRI knee cartilage examination before, immediatly after and 1 month after 3 distinct long-distance mountain races of 40, 55 and 160 km. The physiological responses during the races (speed, heart rate, glycemia) will also be recordered.
- Conditions
- Sports Medicine
- Being tested
- Long-distance mountain running
- Keywords
- long-distance running, knee cartilage, magnetic resonance imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-distance mountain runningOther
Impact of a mountain race on the knee cartilage
| Study group | Role | What they receive |
|---|---|---|
| UT4M 40 | athletes participating to the 40 km mountain race. Receives: Other: Long-distance mountain running | |
| UT4M 160 | athletes participating to the 160 km mountain race. Receives: Other: Long-distance mountain running | |
| UTV 55 | athletes participating to the 55 km mountain race. Receives: Other: Long-distance mountain running |
What is being measured
The primary outcome is the main question the study is designed to answer.
T2 MRI
Change in T2 relaxation time of the knee cartilage
Measured: from before to immediatly after the long-distance race
Secondary outcomes (2)
Heart rate
Mean heart rate during the race
Measured: Continuous measurement during the race
Glycemia
Mean glycemia during the race
Measured: Continuous measurement during the race
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start3 Sep 2020
- Primary completion31 Aug 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sports MedicineStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- stephane Doutreleau, MD, PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04545216
- Sponsor's protocol ID
- UT4M 2020 - 38RC20.008
- Acronym
- UT4M2020
- Status last verified
- Mar 2022
- First submitted
- 3 Sep 2020
- Last updated
- 28 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Impact of an Ultratrail on the Knee Cartilage by Using T2 MRI: a Pilot Study
- ClinicalTrials.gov ID
- NCT04545216
- Acronym / sponsor ID
- UT4M2020 / UT4M 2020 - 38RC20.008
- Conditions
- Sports Medicine
- Keywords
- long-distance running, knee cartilage, magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 3 Sep 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 10 Sep 2020 (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.
Long-distance mountain running is increasingly popular among European and North America countries. Long-distance races are organized in various mountains and can reach up to 160 km (100 miles) with several thousands meters of climbing. The pathophysiological consequences of such extreme effort is still a matter a debate. From a muskelo-skeletal perspectives, the potential lower-limb join damage is a major health issue. The present study aims to use objective magnetic resonance imaging (MRI) techniques to describe the consequences of performing long-distance mountain running races on the knee cartilage.
Detailed description
Healthy male runners will perform T2 MRI knee cartilage examination before, immediatly after and 1 month after 3 distinct long-distance mountain races of 40, 55 and 160 km. The physiological responses during the races (speed, heart rate, glycemia) will also be recordered.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| UT4M 40 | – | Other: Long-distance mountain runningathletes participating to the 40 km mountain race. |
| UT4M 160 | – | Other: Long-distance mountain runningathletes participating to the 160 km mountain race. |
| UTV 55 | – | Other: Long-distance mountain runningathletes participating to the 55 km mountain race. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy male runners
Key inclusion criteria (3 listed)
- no cardiac, respiratory or neuromuscular diseases
- more than 2 years of experience in mountain race
- no contre-indication for participating in a mountain race
Key exclusion criteria (2 listed)
- history of knee surgery
- contre-indication to MRI
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 |
|---|---|---|
| Long-distance mountain runningImpact of a mountain race on the knee cartilage | Other | UT4M 160, UT4M 40, UTV 55 |
Primary outcome
T2 MRI
Time frame: from before to immediatly after the long-distance race
Change in T2 relaxation time of the knee cartilage
2 secondary outcomes
Heart rate
Time frame: Continuous measurement during the race
Glycemia
Time frame: Continuous measurement during the race
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 28 Mar 2022.
- Individual participant dataSharing planned: No
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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.
stephane Doutreleau, MD, PhD principal investigator
University Hospital, Grenoble
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 Sports Medicine, run by University Hospital, Grenoble 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 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 28 Mar 2022. 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?
T2 MRI (time frame: from before to immediatly after the long-distance race). 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 28 Mar 2022.