Making Football Safer for Women: Implementing an Injury Prevention Program (Prep-to-Play)

October 9, 2023 updated by: La Trobe University

Prep-to-Play: Comparing the Impact of Supported and Unsupported Implementation Strategies on the Use of an Injury Prevention Program in Women's/Girl's Community Football

The aim of this study is to determine how we can best support coaches to implement an injury prevention (IP) program (Prep-to-Play) in female community Australian Football. We will recruit at least 140 female community football teams from 15 different football leagues in Victoria, Australia. Teams will be competing in U16, U17, U18, U19 or open womens competitions. We will train and support coaches to implement the IP program and evaluate the effects of the IP program on injuries across two football seasons.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Primary Aim: To compare the impact of supported and unsupported implementation strategies on the use of an IP program (Prep-to-Play) in female community Australian Football.

Secondary aims are to:

  1. Evaluate the effects of supported implementation of Prep-to-Play on injury risk reduction.
  2. Identify barriers and enablers to sustainability of the Prep-to-Play implementation model, and develop clear recommendations for a future, sustainable national roll out of Prep-to-Play.
  3. Evaluate the cost-effectiveness of Prep-to-Play.

Primary hypothesis

The primary hypothesis is that supported implementation will result in increased use of Prep-to-Play in female community Australian Football compared to unsupported implementation.

Secondary hypotheses

The secondary hypotheses are that the supported implementation of Prep-to-Play will:

  • result in a reduction of anterior cruciate ligament (ACL) injuries in females participating in community Australian Football;
  • result in a reduction of other musculoskeletal injuries and concussion among females participating in community Australian Football;
  • be more cost-effective than the unsupported implementation.

Study Type

Interventional

Enrollment (Estimated)

2600

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 Contact

Study Contact Backup

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3121
        • Recruiting
        • Community Australian Football Leagues
        • Contact:

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

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria

  • Coach consents to be trained and to implement Prep-to-Play
  • Team includes players aged 13 years and above registered to play community football
  • The team trains at least once per week in addition to match-play
  • Coach has at least Level I coach accreditation (or enrolled to be accredited in 2021)

Exclusion Criteria:

  • Inability to understand written English
  • Players aged less than 13 years

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: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supported Implementation (Intervention)
Our supported implementation approach is designed to improve uptake of Prep-to-Play. The Prep-to-Play program consists of four components: dynamic warm-up, strength training, football fundamentals, and education. At the start of the intervention period, Prep-to-Play Physiotherapists will conduct a 3-hour workshop for coaches and influential players. Ongoing support will be provided via a range of strategies. Prep-to-Play Physiotherapists will attend training (two times) during and immediately post implementation to provide coaches with support (feedback on missing components, player technique, questions). Monthly Coaches Shed; Online drop-in session with education component to meet other coaches (peer support & networking) and ask questions. Refresher workshops will be run in pre-season 2022 for the teams who have received the intervention in 2021.
Other: Coaching
Physiotherapists (trained by the research team) train the coaches to deliver Prep-to-Play. The Physiotherapists will also provide face-to-face one-to-one support to each coach at their team's training session (two visits), with all their players.
Other: Peer support
Coaches shed. Coaches provide each other with support and ideas. Strategies to overcome barriers and motivate players.
Other: Educational materials
Prep-to-Play program resources are available online for coaches and players to view
Active Comparator: Unsupported implementation (Control)
The unsupported implementation arm will be "usual care". Access to the Prep-to-Play resources, including videos, downloadable manuals and posters, are freely available to coaches online. The online resources incorporate the same four concepts as described in the supported implementation - dynamic warm-up, strength exercises, football fundamentals, and education. In the control arm, no additional resources, education, or support will be provided.
Other: Educational materials
Prep-to-Play program resources are available online for coaches and players to view

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of Prep-to-Play (Primary outcome)
Time Frame: 18 months

Use of Prep-to-Play will be calculated as the proportion of all possible team sessions (training and games) where Prep-to-Play essential components were completed.

The primary outcome assessor will be the Team Designate (i.e., nominated team manager, or team representative) who will record (via the Smartabase App or website) whether essential components of Prep-to-Play were completed at each training session and games.

In addition to the Team Designate, Prep-to-Play Observers (research assistants blinded to randomisation) will make five random visits (≥one prior to the intervention period and ≥two after the intervention period) to observe the execution of Prep-to-Play in order to validate team use data from the Team Designates.
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of players with an ACL injury (Secondary outcome)
Time Frame: 18 months

The primary injuries of interest are ACL injuries and concussion. An ACL/all other injuries will be defined as any injury occurring during a football match or training that results in a player being unable to return to the field of play for that match, or missing at least one match.

ACL injury definition

• Ruptured ACL is confirmed by clinical examination, with or without magnetic resonance imaging or surgery.

Injury data will be collected via two methods to minimise missing data: (i) sports trainer; (ii) direct from player
18 months
Number of players with a concussion (Secondary outcome)
Time Frame: 18 months

A head injury will be defined as any injury to the head region occurring during a football match or training, regardless of time loss.

Concussion definition

• Direct or indirect impact to the head resulting in loss of consciousness and/or any of the following clinical symptoms (memory loss, headache, dizziness, nausea, difficulty concentrating, feeling like being in a fog, feeling not quite right).

Injury data will be collected via two methods to minimise missing data: (i) sports trainer; (ii) direct from player
18 months
Number of player hours (training and match)
Time Frame: 18 months
The number of training and match hours for each team will be collected, and reported at a team-level. Weekly team match exposure will be estimated from the number of matches played, multiplied by the number of players in each match (publicly available registry), and the match length (junior: 1 hour, senior: 1.5 hours). Weekly team training exposure will be estimated using the number and duration of football training sessions completed (reported by team designates), multiplied by the average number of players at training (reported by independent observers on five occasions).
18 months
Healthcare utilisation
Time Frame: 18 months
Healthcare use for players sustaining a knee or head injury will be obtained by the blinded research officer to estimate healthcare costs of sustaining an injury to inform health economic evaluation.
18 months

Collaborators and Investigators

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

Sponsor

La Trobe University

Investigators

  • Principal Investigator: Kay Crossley, PhD, PT, La Trobe University

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)

April 22, 2021

Primary Completion (Estimated)

April 13, 2025

Study Completion (Estimated)

December 21, 2025

Study Registration Dates

First Submitted

April 14, 2021

First Submitted That Met QC Criteria

April 20, 2021

First Posted (Actual)

April 23, 2021

Study Record Updates

Last Update Posted (Actual)

October 11, 2023

Last Update Submitted That Met QC Criteria

October 9, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P2P NHMRC 1193733

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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