Impact of Long Distance Mountain Race on Knee Cartilage. | NCT04545216

Studies
Impact of Long Distance Mountain Race on Knee Cartilage.

NCT04545216

Sponsor

University Hospital, Grenoble

Status

Completed

Last Update Posted

Mar 28, 2022Actual

Enrollment

54Actual

Phase

Not provided

Conditions

Sports Medicine

Interventions

Long-distance mountain running

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 3, 2020Actual

Primary Completion Date

Aug 31, 2021Actual

Completion Date

Dec 31, 2021Actual

First Submitted Date

Sep 3, 2020

First Submission Date that Met QC Criteria

Sep 3, 2020

First Posted Date

Sep 10, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2022

Last Update Posted Date

Mar 28, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

54Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Long-distance mountain running	Other	Impact of a mountain race on the knee cartilage	UT4M 160 UT4M 40 UTV 55

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
T2 MRI	Change in T2 relaxation time of the knee cartilage	from before to immediatly after the long-distance race

Secondary Outcomes

Measure	Description	Time Frame
Heart rate	Mean heart rate during the race	Continuous measurement during the race
Glycemia	Mean glycemia during the race	Continuous measurement during the race

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Healthy male runners

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
stephane Doutreleau, MD, PhD	University Hospital, Grenoble	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Doutreleau		Grenoble		38000	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided