- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04545216
Impact of Long Distance Mountain Race on Knee Cartilage. (UT4M2020)
March 25, 2022 updated by: University Hospital, Grenoble
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
54
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
-
-
-
Grenoble, France, 38000
- Doutreleau
-
-
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 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Sampling Method
Probability Sample
Study Population
Healthy male runners
Description
Inclusion Criteria:
- no cardiac, respiratory or neuromuscular diseases
- more than 2 years of experience in mountain race
- no contre-indication for participating in a mountain race
Exclusion Criteria:
- history of knee surgery
- contre-indication to MRI
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
UT4M 40
athletes participating to the 40 km mountain race.
|
Impact of a mountain race on the knee cartilage
|
UT4M 160
athletes participating to the 160 km mountain race.
|
Impact of a mountain race on the knee cartilage
|
UTV 55
athletes participating to the 55 km mountain race.
|
Impact of a mountain race on the knee cartilage
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
T2 MRI
Time Frame: from before to immediatly after the long-distance race
|
Change in T2 relaxation time of the knee cartilage
|
from before to immediatly after the long-distance race
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart rate
Time Frame: Continuous measurement during the race
|
Mean heart rate during the race
|
Continuous measurement during the race
|
Glycemia
Time Frame: Continuous measurement during the race
|
Mean glycemia during the race
|
Continuous measurement during the race
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: stephane Doutreleau, MD, PhD, University Hospital, Grenoble
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 3, 2020
Primary Completion (Actual)
August 31, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
September 3, 2020
First Submitted That Met QC Criteria
September 3, 2020
First Posted (Actual)
September 10, 2020
Study Record Updates
Last Update Posted (Actual)
March 28, 2022
Last Update Submitted That Met QC Criteria
March 25, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- UT4M 2020 - 38RC20.008
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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