NCT04545216

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

September 3, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 10, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 28, 2022

Status Verified

March 1, 2022

Enrollment Period

12 months

First QC Date

September 3, 2020

Last Update Submit

March 25, 2022

Conditions

Sports Medicine

Keywords

long-distance runningknee cartilagemagnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

  • T2 MRI

    Change in T2 relaxation time of the knee cartilage

    from before to immediatly after the long-distance race

Secondary Outcomes (2)

  • Heart rate

    Continuous measurement during the race

  • Glycemia

    Continuous measurement during the race

Study Arms (3)

UT4M 40

athletes participating to the 40 km mountain race.

Other: Long-distance mountain running

UT4M 160

athletes participating to the 160 km mountain race.

Other: Long-distance mountain running

UTV 55

athletes participating to the 55 km mountain race.

Other: Long-distance mountain running

Interventions

Long-distance mountain runningOTHER

Impact of a mountain race on the knee cartilage

UT4M 160UT4M 40UTV 55

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Healthy male runners

You may qualify if:

  • no cardiac, respiratory or neuromuscular diseases
  • more than 2 years of experience in mountain race
  • no contre-indication for participating in a mountain race

You may not qualify if:

  • history of knee surgery
  • contre-indication to MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Doutreleau

Grenoble, 38000, France

Location

Study Officials

  • stephane Doutreleau, MD, PhD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2020

First Posted

September 10, 2020

Study Start

September 3, 2020

Primary Completion

August 31, 2021

Study Completion

December 31, 2021

Last Updated

March 28, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)