Making Football Safer for Women: Implementing an Injury Prevention Program

Anterior Cruciate Ligament Injuries Clinical Trial

— Prep-to-Play  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04856241
• Other study ID #: P2P NHMRC 1193733
• Status: Recruiting
• Phase: N/A
• Start date: April 22, 2021
• Est. completion date: December 21, 2025

Study information

• Verified date: July 2023
• Source: La Trobe University
• Contact: Sallie Cowan, PhD, PT
• Phone: +61 (03) 94793483
• Email: Sallie.Cowan[@]latrobe.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2600
• Est. completion date: December 21, 2025
• Est. primary completion date: April 13, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Brain Concussion
• Concussion, Brain
• Musculoskeletal Injury
• Wounds and Injuries

Intervention

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.
• Peer support
Coaches shed. Coaches provide each other with support and ideas. Strategies to overcome barriers and motivate players.
• Educational materials
Prep-to-Play program resources are available online for coaches and players to view

Locations

Country	Name	City	State
Australia	Community Australian Football Leagues	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
La Trobe University

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of Prep-to-Play (Primary outcome)	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	Number of players with an ACL injury (Secondary outcome)	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
Secondary	Number of players with a concussion (Secondary outcome)	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
Secondary	Number of player hours (training and match)	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
Secondary	Healthcare utilisation	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