NCT05635422

Brief Summary

The aim of this study is to evaluate the relevance of carrying out a measure of muscular fatigability by isokinetism, in the search for factors favouring micro-traumatic lesions of the lower limbs in a population of triathletes. This is a prospective monocentric pilot study of the before/after type in which the patient is his or her own control, in high-level triathletes practising an endurance sport, who have had more than 7 consecutive days off running due to a musculoskeletal injury during the previous sporting year.

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
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

November 14, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 15, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 2, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2024

Completed
Last Updated

December 2, 2022

Status Verified

November 1, 2022

Enrollment Period

2 years

First QC Date

November 15, 2022

Last Update Submit

November 30, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • fatigue index between the injured leg and the healthy leg

    To compare the fatigue index between the injured leg and the healthy leg in high level triathletes injured in the previous season.

    the day of inclusion

Secondary Outcomes (1)

  • difference of the fatigue index to the difference of the Croisier ratio between the injured leg and the healthy leg

    the day of inclusion

Study Arms (1)

isokinetism test in high level triathletes practicing an endurance sport

EXPERIMENTAL
Diagnostic Test: isokinetism test

Interventions

isokinetism testDIAGNOSTIC_TEST

measure of muscular fatigability by isokinetism

isokinetism test in high level triathletes practicing an endurance sport

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Having had a practical running break of more than 7 consecutive days due to a musculoskeletal injury of a lower limb during the previous sport year
  • Willing to comply with all study procedures
  • Having given written consent
  • Socially insured

You may not qualify if:

  • Pain that does not allow an isokinetic test to be performed
  • Knee joint amplitude less than 100° of flexion or flessum greater than 5°.
  • History of rupture or ligamentoplasty of the anterior cruciate ligament less than 2 years ago
  • History of knee surgery less than 2 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boulogne sur mer Hospital Center

Boulogne-sur-Mer, 62200, France

RECRUITING

MeSH Terms

Conditions

Musculoskeletal Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2022

First Posted

December 2, 2022

Study Start

November 14, 2022

Primary Completion

November 14, 2024

Study Completion

November 14, 2024

Last Updated

December 2, 2022

Record last verified: 2022-11

Locations