Making Football Safer for Women: Implementing an Injury Prevention Program

NCT ID: NCT04856241

Last Updated: 2023-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-22

Study Completion Date

2025-12-21

Brief Summary

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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

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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.

Conditions

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Anterior Cruciate Ligament Injuries Concussion, Brain Musculoskeletal Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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).
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
It will not be possible to blind all involved research fellows, or the Prep-to-Play Physiotherapists involved in the project. The statistician will be unblinded to information required to complete the analyses (i.e. timing of transition) but blinded to team information (e.g. location, name). Teams will be given a unique code.

To optimise allocation concealment: i) each cluster will be a league or leagues in a unique geographical area; ii) data collection at all sites will commence in the control period, iii) team designate and/or sports trainers will remain blinded to allocation sequence; iv) Prep-to-Play observers validating the primary outcome (Prep-to-Play implementation) will be independent to the club and blinded to allocation; v) research fellows collecting injury data will be independent of the club and blinded to allocation.

Study Groups

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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.

Group Type EXPERIMENTAL

Peer support

Intervention Type OTHER

Coaches shed. Coaches provide each other with support and ideas. Strategies to overcome barriers and motivate players.

Educational materials

Intervention Type OTHER

Prep-to-Play program resources are available online for coaches and players to view

Coaching

Intervention Type OTHER

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.

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.

Group Type ACTIVE_COMPARATOR

Educational materials

Intervention Type OTHER

Prep-to-Play program resources are available online for coaches and players to view

Interventions

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Peer support

Coaches shed. Coaches provide each other with support and ideas. Strategies to overcome barriers and motivate players.

Intervention Type OTHER

Educational materials

Prep-to-Play program resources are available online for coaches and players to view

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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La Trobe University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kay Crossley, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

La Trobe University

Locations

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Community Australian Football Leagues

Melbourne, Victoria, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Sallie Cowan, PhD, PT

Role: CONTACT

+61 (03) 94793483

Brooke Patterson, PhD, PT

Role: CONTACT

+61 (03) 94793483

Facility Contacts

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Brooke Patterson

Role: primary

0418527768

References

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Patterson 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.

Reference Type DERIVED
PMID: 36104145 (View on PubMed)

Other Identifiers

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P2P NHMRC 1193733

Identifier Type: -

Identifier Source: org_study_id

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