To Evaluate the Effectiveness of an Injury Prevention Program in Athletics (PREVATHLE)

December 3, 2018 updated by: Centre Hospitalier Universitaire de Saint Etienne

PREVATHLE: To Evaluate the Effectiveness of an Injury Prevention Program in Athletics

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

880

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Étienne, France
        • CHU Saint-Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
experimental group is composed of athletes will be followed the Athletics Injury Prevention Program
Other: Athletics Injury Prevention Program
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.
Other Names:
  • AIPP
Active Comparator: control group
control group is composed of athletes will be continued their regular training
Other: regular training
The regular training will be performed by control group according to the standard practice.
Other Names:
  • standard practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
injury complaint and have a consequence on the practice
Time Frame: at 40 weeks
Frequency of athletes presenting at least one injury complaint and have a consequence on the practice (reduction or cessation of practice).
at 40 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
injury complaint number and hours number of athletic practice
Time Frame: at 40 weeks
Correlation between injury complaint number and hours number of athletic practice
at 40 weeks
injury complaint number and weeks number of athletic practice
Time Frame: at 40 weeks
Correlation between injury complaint number and weeks number of athletic practice
at 40 weeks
week without injury complaints
Time Frame: at 40 weeks
Frequency of week without injury complaints
at 40 weeks
injury complaint number at the training
Time Frame: at 40 weeks
Frequency of injury complaint number at the training
at 40 weeks
injury complaint number and at the competition
Time Frame: at 40 weeks
Frequency of injury complaint number at the competition
at 40 weeks
type of injury complaint between 4 consequences
Time Frame: at 40 weeks
the 4 consequences of injury complaint are : No consequence of athletic practice; reduce practice; Stop practice; and Consequence of practice
at 40 weeks
injury complaint number by groups
Time Frame: at 40 weeks
Correlation of injury complaint number by groups
at 40 weeks
injury complaint type
Time Frame: at 40 weeks
Number of injury complaint type: hamstrings, Achilles tendons, ankles, knees and rachis
at 40 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Pascal EDOUARD, MD, CHU Saint-Etienne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2017

Primary Completion (Actual)

July 29, 2018

Study Completion (Actual)

July 29, 2018

Study Registration Dates

First Submitted

October 2, 2017

First Submitted That Met QC Criteria

October 10, 2017

First Posted (Actual)

October 11, 2017

Study Record Updates

Last Update Posted (Actual)

December 4, 2018

Last Update Submitted That Met QC Criteria

December 3, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1708116
  • ID-RCB (Other Identifier: 2026-A00289-42)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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