- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05635422
Isokinetic Fatigue Index in a Population of Triathletes (ISOTRIFA)
Pilot Study to Evaluate an Isokinetic Fatigue Index for Prevention Purposes in a Population of Triathletes
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Guillaume BERTOUX
- Phone Number: + 33 3 21 99 87 13
- Email: g.bertoux@ch-boulogne.fr
Study Contact Backup
- Name: Yoann MORVAN
- Phone Number: + 33 3 21 99 33 85
- Email: y.morvan@ch-boulogne.fr
Study Locations
-
-
-
Boulogne-sur-Mer, France, 62200
- Recruiting
- Boulogne sur Mer Hospital Center
-
Principal Investigator:
- Yoann MORVAN
-
Contact:
- Justine MONVOISIN
- Phone Number: + 33 3 21 99 34 40
- Email: j.monvoisin@ch-boulogne.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: isokinetism test in high level triathletes practicing an endurance sport
|
measure of muscular fatigability by isokinetism
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
fatigue index between the injured leg and the healthy leg
Time Frame: the day of inclusion
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
difference of the fatigue index to the difference of the Croisier ratio between the injured leg and the healthy leg
Time Frame: the day of inclusion
|
Correlate the difference in the fatigue index to the difference in the Croisier ratio between the injured leg and the healthy leg.
|
the day of inclusion
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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