Isokinetic Fatigue Index in a Population of Triathletes (ISOTRIFA)
Primary Purpose
Musculoskeletal Diseases
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
isokinetism test
Sponsored by
About this trial
This is an interventional prevention trial for Musculoskeletal Diseases
Eligibility Criteria
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
Sites / Locations
- Boulogne sur mer Hospital CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
isokinetism test in high level triathletes practicing an endurance sport
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
difference of the fatigue index to the difference of the Croisier ratio between the injured leg and the healthy leg
Correlate the difference in the fatigue index to the difference in the Croisier ratio between the injured leg and the healthy leg.
Full Information
NCT ID
NCT05635422
First Posted
November 15, 2022
Last Updated
November 30, 2022
Sponsor
Boulogne sur Mer Hospital Center
1. Study Identification
Unique Protocol Identification Number
NCT05635422
Brief Title
Isokinetic Fatigue Index in a Population of Triathletes
Acronym
ISOTRIFA
Official Title
Pilot Study to Evaluate an Isokinetic Fatigue Index for Prevention Purposes in a Population of Triathletes
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 14, 2022 (Actual)
Primary Completion Date
November 14, 2024 (Anticipated)
Study Completion Date
November 14, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boulogne sur Mer Hospital Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Diseases
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
isokinetism test in high level triathletes practicing an endurance sport
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
isokinetism test
Intervention Description
measure of muscular fatigability by isokinetism
Primary Outcome Measure Information:
Title
fatigue index between the injured leg and the healthy leg
Description
To compare the fatigue index between the injured leg and the healthy leg in high level triathletes injured in the previous season.
Time Frame
the day of inclusion
Secondary Outcome Measure Information:
Title
difference of the fatigue index to the difference of the Croisier ratio between the injured leg and the healthy leg
Description
Correlate the difference in the fatigue index to the difference in the Croisier ratio between the injured leg and the healthy leg.
Time Frame
the day of inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guillaume BERTOUX
Phone
+ 33 3 21 99 87 13
Email
g.bertoux@ch-boulogne.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Yoann MORVAN
Phone
+ 33 3 21 99 33 85
Email
y.morvan@ch-boulogne.fr
Facility Information:
Facility Name
Boulogne sur mer Hospital Center
City
Boulogne-sur-Mer
ZIP/Postal Code
62200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justine MONVOISIN
Phone
+ 33 3 21 99 34 40
Email
j.monvoisin@ch-boulogne.fr
First Name & Middle Initial & Last Name & Degree
Yoann MORVAN
12. IPD Sharing Statement
Learn more about this trial
Isokinetic Fatigue Index in a Population of Triathletes
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