To Evaluate the Effectiveness of an Injury Prevention Program in Athletics (PREVATHLE)
Primary Purpose
Athletics, Wounds and Injuries, Prevention Program
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Athletics Injury Prevention Program
regular training
Sponsored by
About this trial
This is an interventional prevention trial for Athletics focused on measuring Program, Prevention, Injury, Athletics
Eligibility Criteria
Inclusion Criteria:
- To dismissed in athletics clubs affiliated to French Federation of Athletics
- To practice one of the disciplines of athletics
- Men or women aged between 15 and 40 years
Exclusion Criteria:
- Patient's refusal to participate in the study and / or inability to express agreement or signing the informed consent
Sites / Locations
- Chu Saint-Etienne
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
experimental group
control group
Arm Description
experimental group is composed of athletes will be followed the Athletics Injury Prevention Program
control group is composed of athletes will be continued their regular training
Outcomes
Primary Outcome Measures
injury complaint and have a consequence on the practice
Frequency of athletes presenting at least one injury complaint and have a consequence on the practice (reduction or cessation of practice).
Secondary Outcome Measures
injury complaint number and hours number of athletic practice
Correlation between injury complaint number and hours number of athletic practice
injury complaint number and weeks number of athletic practice
Correlation between injury complaint number and weeks number of athletic practice
week without injury complaints
Frequency of week without injury complaints
injury complaint number at the training
Frequency of injury complaint number at the training
injury complaint number and at the competition
Frequency of injury complaint number at the competition
type of injury complaint between 4 consequences
the 4 consequences of injury complaint are : No consequence of athletic practice; reduce practice; Stop practice; and Consequence of practice
injury complaint number by groups
Correlation of injury complaint number by groups
injury complaint type
Number of injury complaint type: hamstrings, Achilles tendons, ankles, knees and rachis
Full Information
NCT ID
NCT03307434
First Posted
October 2, 2017
Last Updated
December 3, 2018
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
1. Study Identification
Unique Protocol Identification Number
NCT03307434
Brief Title
To Evaluate the Effectiveness of an Injury Prevention Program in Athletics
Acronym
PREVATHLE
Official Title
PREVATHLE: To Evaluate the Effectiveness of an Injury Prevention Program in Athletics
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
October 23, 2017 (Actual)
Primary Completion Date
July 29, 2018 (Actual)
Study Completion Date
July 29, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The practice of Athletics leads to risk of injuries: about 61 to 76% athletes will occurred at least one injury during a season. The prevention of Athletics injuries thus represents a major challenge for all stakeholders around athletes. In team sports, injury prevention programs have been implemented and scientifically validated. However, no injury prevention programs have been implemented and scientifically validated for Athletics. In this context, a primary objective will be to analyze the effectiveness of an Athletics Injury Prevention Program (AIPP) to reduce the frequency (percentage) of athletes presenting at least one injury complaint related to athletic practice at long term (40 weeks). A statistician will carry out a randomized control trial in cluster (clubs with AIPP and clubs without AIPP), multicenter, including athletes between 15 and 40 years old and licensed in athletic clubs and followed during an athletic season.
Detailed Description
The person in charge of the platform will collect on a weekly basis via a IT-questionnaire sent out automatically every Monday the following parameters: injury complaints (presence or absence, and characteristics if presence) and exposure (number of hours of athletic practice (training and competition) and intensity), and the number of AIPP realization per week. The main criterion will be the frequency (percentage) of athletes presenting at least one injury complaint that have a consequence on the practice (reduction or cessation of practice).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Athletics, Wounds and Injuries, Prevention Program
Keywords
Program, Prevention, Injury, Athletics
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
880 (Actual)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Description
experimental group is composed of athletes will be followed the Athletics Injury Prevention Program
Arm Title
control group
Arm Type
Active Comparator
Arm Description
control group is composed of athletes will be continued their regular training
Intervention Type
Other
Intervention Name(s)
Athletics Injury Prevention Program
Other Intervention Name(s)
AIPP
Intervention Description
The Athletics Injury Prevention Program (AIPP) will be performed by experimental group twice a week. The AIPP is composed of 8 exercises including core stability, balance, pelvic stabilization, stretching and strengthening of the Achilles tendon and hamstrings.
Intervention Type
Other
Intervention Name(s)
regular training
Other Intervention Name(s)
standard practice
Intervention Description
The regular training will be performed by control group according to the standard practice.
Primary Outcome Measure Information:
Title
injury complaint and have a consequence on the practice
Description
Frequency of athletes presenting at least one injury complaint and have a consequence on the practice (reduction or cessation of practice).
Time Frame
at 40 weeks
Secondary Outcome Measure Information:
Title
injury complaint number and hours number of athletic practice
Description
Correlation between injury complaint number and hours number of athletic practice
Time Frame
at 40 weeks
Title
injury complaint number and weeks number of athletic practice
Description
Correlation between injury complaint number and weeks number of athletic practice
Time Frame
at 40 weeks
Title
week without injury complaints
Description
Frequency of week without injury complaints
Time Frame
at 40 weeks
Title
injury complaint number at the training
Description
Frequency of injury complaint number at the training
Time Frame
at 40 weeks
Title
injury complaint number and at the competition
Description
Frequency of injury complaint number at the competition
Time Frame
at 40 weeks
Title
type of injury complaint between 4 consequences
Description
the 4 consequences of injury complaint are : No consequence of athletic practice; reduce practice; Stop practice; and Consequence of practice
Time Frame
at 40 weeks
Title
injury complaint number by groups
Description
Correlation of injury complaint number by groups
Time Frame
at 40 weeks
Title
injury complaint type
Description
Number of injury complaint type: hamstrings, Achilles tendons, ankles, knees and rachis
Time Frame
at 40 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
To dismissed in athletics clubs affiliated to French Federation of Athletics
To practice one of the disciplines of athletics
Men or women aged between 15 and 40 years
Exclusion Criteria:
- Patient's refusal to participate in the study and / or inability to express agreement or signing the informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal EDOUARD, MD
Organizational Affiliation
CHU SAINT-ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Saint-Etienne
City
Saint-Étienne
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34769849
Citation
Edouard P, Steffen K, Peuriere M, Gardet P, Navarro L, Blanco D. Effect of an Unsupervised Exercises-Based Athletics Injury Prevention Programme on Injury Complaints Leading to Participation Restriction in Athletics: A Cluster-Randomised Controlled Trial. Int J Environ Res Public Health. 2021 Oct 28;18(21):11334. doi: 10.3390/ijerph182111334.
Results Reference
derived
Learn more about this trial
To Evaluate the Effectiveness of an Injury Prevention Program in Athletics
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