NCT03307434

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
880

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 2, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 11, 2017

Completed
12 days until next milestone

Study Start

First participant enrolled

October 23, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2018

Completed
Last Updated

December 4, 2018

Status Verified

September 1, 2018

Enrollment Period

9 months

First QC Date

October 2, 2017

Last Update Submit

December 3, 2018

Conditions

Keywords

ProgramPreventionInjuryAthletics

Outcome Measures

Primary Outcomes (1)

  • 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).

    at 40 weeks

Secondary Outcomes (8)

  • injury complaint number and hours number of athletic practice

    at 40 weeks

  • injury complaint number and weeks number of athletic practice

    at 40 weeks

  • week without injury complaints

    at 40 weeks

  • injury complaint number at the training

    at 40 weeks

  • injury complaint number and at the competition

    at 40 weeks

  • +3 more secondary outcomes

Study Arms (2)

experimental group

EXPERIMENTAL

experimental group is composed of athletes will be followed the Athletics Injury Prevention Program

Other: Athletics Injury Prevention Program

control group

ACTIVE COMPARATOR

control group is composed of athletes will be continued their regular training

Other: regular training

Interventions

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.

Also known as: AIPP
experimental group

The regular training will be performed by control group according to the standard practice.

Also known as: standard practice
control group

Eligibility Criteria

Age15 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • \- Patient's refusal to participate in the study and / or inability to express agreement or signing the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, France

Location

Related Publications (3)

  • Iatropoulos S, Dandrieux PE, Navarro L, Blanco D, Edouard P. The Dose-Response Relationship of an Exercise-Based Injury Prevention Program: A Secondary Analysis of a Randomized Controlled Trial on Athletics (Track-and-Field) Athletes Over a 39-Week Follow-Up. Scand J Med Sci Sports. 2024 Sep;34(9):e14720. doi: 10.1111/sms.14720.

  • Edouard P, Tondut J, Hollander K, Dandrieux PE, Navarro L, Bruneau A, Junge A, Blanco D. Risk factors for injury complaints leading to restricted participation in Athletics (Track and Field): a secondary analysis of data from 320 athletes over one season. BMJ Open Sport Exerc Med. 2023 Dec 7;9(4):e001718. doi: 10.1136/bmjsem-2023-001718. eCollection 2023.

  • 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.

MeSH Terms

Conditions

Wounds and Injuries

Interventions

2-amino-5-iodo-6-phenyl-4-pyrimidinone

Study Officials

  • Pascal EDOUARD, MD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2017

First Posted

October 11, 2017

Study Start

October 23, 2017

Primary Completion

July 29, 2018

Study Completion

July 29, 2018

Last Updated

December 4, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations