NCT06269471

Brief Summary

The number of trailers is growing all the time, and TRu seems to be a risky activity for the ankle joint. Ankle sprains can lead to significant health consequences, as in the case of chronic ankle instability. However, there are no studies informing of the prevalence of chronic ankle instability in trail running. The aim of this study is therefore to take stock of chronic ankle instability in trail running in France.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
385

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

December 4, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

February 21, 2024

Status Verified

February 1, 2024

Enrollment Period

3 months

First QC Date

December 4, 2023

Last Update Submit

February 12, 2024

Conditions

Keywords

Chronic Ankle InstabilityTrail RunningUltra Trail RunningAnkle SprainPrevalence

Outcome Measures

Primary Outcomes (1)

  • Prevalence of chronic ankle instability in trailers

    Number of cases among all respondents with a Cumberland Ankle Instability Tool Score ≤ 23 points for the French version end ≤ 25 points for the English version. (validated questionnaire)

    Time 0

Secondary Outcomes (20)

  • Socio-demographic data (1/4)

    Time 0

  • Socio-demographic data (2/4)

    Time 0

  • Socio-demographic data (3/4)

    Time 0

  • Socio-demographic data (4/4)

    Time 0

  • Trail running and prevalence reports (1/11)

    Time 0

  • +15 more secondary outcomes

Study Arms (1)

Trailers

Group of major trail runners who have already taken part in at least one trail running competition in their lives.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult Trail Running racers who have participated in at least one Trail Running competition in their lifetime. Subjects will be recruited via an online questionnaire distributed through various French Trail Running organizations and social networks.

You may qualify if:

  • Trail Running
  • Ultra Trail Running runners
  • Having participated́ in at least one Trail Running or Ultra Trail Running competition in their lifetime.
  • Over 18 years of age (adult participants)

You may not qualify if:

  • Adults protected under Article L1121-8 of the French Public Health Code
  • Minors
  • Adults unable to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Grenoble Alpes

Grenoble, 38000, France

Location

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Leo Druart, PhD

    University Grenoble Alpes

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

December 4, 2023

First Posted

February 21, 2024

Study Start

March 1, 2024

Primary Completion

May 30, 2024

Study Completion

July 30, 2024

Last Updated

February 21, 2024

Record last verified: 2024-02

Locations