Anterior Cruciate Ligament InjuriesPrep-to-PlayNCT04856241
Making Football Safer for Women: Implementing an Injury Prevention Program
A study testing Coaching, Peer support and Educational materials in people with Anterior Cruciate Ligament Injuries and Concussion, Brain, run by La Trobe University at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 14 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Injuries, Concussion, Brain, Musculoskeletal Injury
- What is being tested?
- Coaching, Peer support and Educational materials
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,600 participants
- Where
- 1 siteAustralia
- Study dates
- 22 Apr 2021to 21 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Inability to understand written English
- Players aged less than 13 years
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Community Australian Football Leagues
Melbourne, Victoria, 3121
Brooke Patterson, 0418527768, B.Patterson@latrobe.edu.au
About this study
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
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.
Read the 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:
- Evaluate the effects of supported implementation of Prep-to-Play on injury risk reduction.
- 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.
- 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.
- Being tested
- Coaching, Peer support, Educational materials
- Keywords
- injury prevention, implementation, football, female
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoachingOther
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 supportOther
Coaches shed. Coaches provide each other with support and ideas. Strategies to overcome barriers and motivate players.
Educational materialsOther
Prep-to-Play program resources are available online for coaches and players to view
| Study group | Role | What they receive |
|---|---|---|
| Supported Implementation (Intervention) | Experimental | 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. Receives: Other: Coaching; Other: Peer support; Other: Educational materials |
| Unsupported implementation (Control) | Active comparator | 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. Receives: Other: Educational materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (4)
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
Measured: 18 months
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
Measured: 18 months
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).
Measured: 18 months
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start22 Apr 2021
- Primary completion13 Apr 2025 (estimated)
- Study completion21 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Stepped-wedge randomised controlled trial. Prior to study initiation, the leagues will be randomly allocated to one of the five wedges for time of crossover from the control to the intervention phase using a computer-generated list of random numbers provided by a statistician. The randomisation sequence will be concealed to the coaches until shortly before the switch (\~four weeks to allow time to organise their workshop).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- La Trobe University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kay Crossley, PhD, PT, Principal investigator, La Trobe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04856241
- Sponsor's protocol ID
- P2P NHMRC 1193733
- Acronym
- Prep-to-Play
- Status last verified
- Jul 2023
- First submitted
- 14 Apr 2021
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Patterson BE, White NM, Cowan SM, King MG, Donaldson A, Haberfield MJ, Mosler AB, Bruder AM, Barton CJ, McPhail SM, Culvenor AG, Hemming K, Hagglund M, Lannin NA, Ackerman IN, Dowsey MM, Makdissi M, Sundaraj S, Livingstone N, Fitzpatrick J, Crain J, Lampard SJ, Roughead EA, Chilman KL, Gracias LJ, Birch E, Bonello C, Crossley KM. Supported implementation enhances injury prevention programme (Prep-to-Play) use in women and girls playing Australian Football: a pragmatic type III hybrid implementation-effectiveness stepped wedge cluster randomised trial. Br J Sports Med. 2026 Jun 8;60(11):788-799. doi: 10.1136/bjsports-2025-110894.
PubMed 42091212Patterson BE, Donaldson A, Cowan SM, King MG, Barton CG, McPhail SM, Hagglund M, White NM, Lannin NA, Ackerman IN, Dowsey MM, Hemming K, Makdissi M, Culvenor AG, Mosler AB, Bruder AM, Choong J, Livingstone N, Elliott RK, Nikolic A, Fitzpatrick J, Crain J, Haberfield MJ, Roughead EA, Birch E, Lampard SJ, Bonello C, Chilman KL, Crossley KM. Evaluation of an injury prevention programme (Prep-to-Play) in women and girls playing Australian Football: design of a pragmatic, type III, hybrid implementation-effectiveness, stepped-wedge, cluster randomised controlled trial. BMJ Open. 2022 Sep 14;12(9):e062483. doi: 10.1136/bmjopen-2022-062483.
PubMed 36104145
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04856241
- Acronym / sponsor ID
- Prep-to-Play / P2P NHMRC 1193733
- Keywords
- injury prevention, implementation, football, female
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,600 participants (estimated)
- Lead sponsor
- La Trobe UniversityUniversity, hospital or other
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 13 Apr 2025 (estimated)
- Study completion
- 21 Dec 2025 (estimated)
- First posted
- 23 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Evaluate the effects of supported implementation of Prep-to-Play on injury risk reduction.
- 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.
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Stepped-wedge randomised controlled trial. Prior to study initiation, the leagues will be randomly allocated to one of the five wedges for time of crossover from the control to the intervention phase using a computer-generated list of random numbers provided by a statistician. The randomisation sequence will be concealed to the coaches until shortly before the switch (~four weeks to allow time to organise their workshop).
| Arm | Type | Receives |
|---|---|---|
| Supported Implementation (Intervention) | Experimental | Other: Coaching, Other: Peer support, Other: Educational materialsOur 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. |
| Unsupported implementation (Control) | Active comparator | Other: Educational materialsThe 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. |
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- Inability to understand written English
- Players aged less than 13 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoachingPhysiotherapists (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 | Supported Implementation (Intervention) |
| Peer supportCoaches shed. Coaches provide each other with support and ideas. Strategies to overcome barriers and motivate players. | Other | Supported Implementation (Intervention) |
| Educational materialsPrep-to-Play program resources are available online for coaches and players to view | Other | Supported Implementation (Intervention), Unsupported implementation (Control) |
Primary outcome
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.
4 secondary outcomes
Number of players with an ACL injury (Secondary outcome)
Time frame: 18 months
Number of players with a concussion (Secondary outcome)
Time frame: 18 months
Number of player hours (training and match)
Time frame: 18 months
Healthcare utilisation
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Derived from this study: PubMed 42091212Patterson BE, White NM, Cowan SM, King MG, Donaldson A, Haberfield MJ, Mosler AB, Bruder AM, Barton CJ, McPhail SM, Culvenor AG, Hemming K, Hagglund M, Lannin NA, Ackerman IN, Dowsey MM, Makdissi M, Sundaraj S, Livingstone N, Fitzpatrick J, Crain J, Lampard SJ, Roughead EA, Chilman KL, Gracias LJ, Birch E, Bonello C, Crossley KM. Supported implementation enhances injury prevention programme (Prep-to-Play) use in women and girls playing Australian Football: a pragmatic type III hybrid implementation-effectiveness stepped wedge cluster randomised trial. Br J Sports Med. 2026 Jun 8;60(11):788-799. doi: 10.1136/bjsports-2025-110894.
- Derived from this study: PubMed 36104145Patterson BE, Donaldson A, Cowan SM, King MG, Barton CG, McPhail SM, Hagglund M, White NM, Lannin NA, Ackerman IN, Dowsey MM, Hemming K, Makdissi M, Culvenor AG, Mosler AB, Bruder AM, Choong J, Livingstone N, Elliott RK, Nikolic A, Fitzpatrick J, Crain J, Haberfield MJ, Roughead EA, Birch E, Lampard SJ, Bonello C, Chilman KL, Crossley KM. Evaluation of an injury prevention programme (Prep-to-Play) in women and girls playing Australian Football: design of a pragmatic, type III, hybrid implementation-effectiveness, stepped-wedge, cluster randomised controlled trial. BMJ Open. 2022 Sep 14;12(9):e062483. doi: 10.1136/bmjopen-2022-062483.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kay Crossley, PhD, PT principal investigator
La Trobe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coaching, Peer support and Educational materials in people with Anterior Cruciate Ligament Injuries and Concussion, Brain, run by La Trobe University at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sallie Cowan, PhD, PT (+61 (03) 94793483, Sallie.Cowan@latrobe.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of Prep-to-Play (Primary outcome) (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04856241, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2023.