An interventional study of Coaching and Peer support in Anterior Cruciate Ligament Injuries, Concussion, Brain and Musculoskeletal Injury, sponsored by La Trobe University. Recruiting at 1 site in Australia. Open to female participants aged 14 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-11.
Sponsored by La Trobe University · Not applicable, Interventional, and Prevention
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.
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:
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:
625 studies on the registry are indexed under Anterior Cruciate Ligament Injuries; 192 are open to participants now.
This study's planned enrollment of 2,600 is above the median of 56 across 458 interventional studies indexed under Anterior Cruciate Ligament Injuries.
Browse Anterior Cruciate Ligament Injuries studies →La Trobe University is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
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 · Other: Peer support · Other: Educational materials
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
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.
Coaches shed. Coaches provide each other with support and ideas. Strategies to overcome barriers and motivate players.
Prep-to-Play program resources are available online for coaches and players to view
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.
Time frame: 18 months
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
Time frame: 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
Time frame: 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).
Time frame: 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.
Time frame: 18 months
Plan to share: No
Started Apr 2021 (actual). Primary completion is estimated for Apr 2025, 47 months after the start.
Of 277 non-industry interventional studies with no phase under Anterior Cruciate Ligament Injuries, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 70. This study's planned 47 months is above that.
Counting every sponsor, half of 286 studies reached it within 30 months; a quarter within 14 and three quarters within 70.
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