Enhancing Prevention of Injuries in Community (EPIC) Youth and Adult Amateur Football Players - Design of a Type 3 Hybrid Implementation-effectiveness Cluster Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,600
- 试验地点
- 1
- 主要终点
- Use of Knee Control+
研究概览
简要总结
This is a type 3 hybrid cluster randomised controlled trial, where implementation of the intervention is the primary outcome and preventive effectiveness is the secondary outcome.
The overall purpose of this study is to evaluate the added value of implementation support on the use and preventive effectiveness of the injury prevention exercise programme Knee Control+ in male and female, youth and adult amateur football teams.
Research questions
- Does use and injury preventive effect of Knee Control+ differ between teams randomised to an intervention group receiving additional support for Knee Control+ use and teams randomised to a control group with standard access to digital Knee Control+ programme material?
- Does coach self-efficacy to use Knee Control+, player motivation and player training dosage differ between the intervention and control groups?
- What are the mediators and moderators that influence use of Knee Control+?
- How well do the intervention and control groups adhere to Knee Control+ recommended use and is there an association between adherence and preventive efficacy?
- How are different components of the support material used by the intervention group teams, and how is the implementation support perceived by administrators, coaches and players in the clubs (end-users) and by fitness coaches who educate coaches about the programme (intervention deliverers)?
- How do coaches perceive their engagement to lead Knee Control+ training with their players and has this changed after having used the implementation support material?
Football teams will be randomised before the 2025 season to an intervention group receiving additional support for the implementation of Knee Control+ or to a control group without this support. All teams will have access to digital programme material via the Swedish Football Association.
Data on implementation of Knee Control+ and injuries (players only) will be collected weekly (coaches) and monthly (players) throughout the season using web-based questionnaires. Behavioural outcomes: for coaches self-efficacy, action and coping planning and perceived support from the club, and for players autonomous motivation, basic psychological needs and basic need support, will also be analysed.
详细描述
This is a one-season study in the 2025 football season, beginning in the pre-season (March) and ending after the competitive season (November). Football coaches and players are included in the study. A sub-sample of coaches will also be included in a qualitative sub-study after the 2025 season. As part of a process evaluation, club representatives, such as club chairmen, sports directors and youth managers, will also be targeted in the same district, as well as fitness coaches delivering the interventions to the coaches. Coaches will be targeted with most of the interventions, but players and club managers will also benefit from some of the support interventions.
Fitness coaches in a nation-wide organisation (Friskis&Svettis) will be the primary intervention-deliverers and will be educated on the Knee Control+ programme exercises and support interventions to be able to hold workshops at their venues as well as to make site visits in the teams. The research group will be responsible for the education of fitness coaches and will deliver the digital workshops to the coaches and manage the social media account.
Co-design in development of the support material has been employed. During the 2024 season, a working group with representatives for coaches and players (for practical reasons age ≥ 18) was initiated. This working group (two coaches, one former player) provided feedback and new ideas during the development of the support material and the questionnaires for coaches and players.
The workshop concept was tested three times with fitness coaches leading workshops for football coaches during the autumn of 2024 in a district not included in the main study. One site visit was also accomplished and the fitness coaches gave feedback of their experiences to the research group after this.
In the planning and execution of the study, the research group will have regular contact with representatives for football clubs, the district football associations, the Swedish football association and the fitness coach association (Friskis&Svettis) to get their strategic input on the work being done.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female, youth and adult amateur football teams
- •Teams participating in series for players 10 years or older
- •Teams with scheduled training at least twice per week during the season
- •All eligible players in the team are invited to participate, regardless of whether they have an injury or not at study start
排除标准
- •Players with long-term injuries not planning to take part in match play in the 2025 season
研究组 & 干预措施
Control group with standard introduction of Knee Control+
The control group will gain access to the same digital Knee Control+ programme material from the Swedish Football Association website in the pre-season and will be introduced to the programme during a digital workshop prior to study start.
干预措施: Information about Knee Control+ (Other)
Intervention group receiving support for implementation of Knee Control+
Teams in the intervention group will gain access to digital Knee Control+ programme material from the Swedish Football Association website in the pre-season and be introduced to the programme during a digital workshop prior to season start. Additionally, coaches will be offered a smorgasbord of support interventions that they can choose from depending on their specific needs:
- physical and digital workshops aiming to increase coach self-efficacy and formalisation of action and coping plans,
- site visits to their teams by a study designated fitness coach, aiming to increase coach self-efficacy and player autonomous motivation,
- digital programme material with films aiming to increase coach knowledge and inspiration to use Knee Control+,
- leaflets about Knee Control+ as inspiration and reminder to use the programme,
- social media support as reminder to use the programme.
Site visits and physical workshops will be led by specifically trained fitness coaches.
干预措施: Support intervention for the use of Knee Control+ (Behavioral)
Intervention group receiving support for implementation of Knee Control+
Teams in the intervention group will gain access to digital Knee Control+ programme material from the Swedish Football Association website in the pre-season and be introduced to the programme during a digital workshop prior to season start. Additionally, coaches will be offered a smorgasbord of support interventions that they can choose from depending on their specific needs:
- physical and digital workshops aiming to increase coach self-efficacy and formalisation of action and coping plans,
- site visits to their teams by a study designated fitness coach, aiming to increase coach self-efficacy and player autonomous motivation,
- digital programme material with films aiming to increase coach knowledge and inspiration to use Knee Control+,
- leaflets about Knee Control+ as inspiration and reminder to use the programme,
- social media support as reminder to use the programme.
Site visits and physical workshops will be led by specifically trained fitness coaches.
干预措施: Information about Knee Control+ (Other)
结局指标
主要结局
Use of Knee Control+
时间窗: One season, 7 months, from start of the competitive season (April 2025) to the end of the competitive season (October 2025)
Proportion of weeks in the season with Knee Control+ training being performed at least 2 times in that week with sufficient completion of Knee Control+ components: for players 10-12 years, use of at least 3 of 6 main exercises OR for players \>12 years, use of at least 4 of 6 main exercises, as reported by coaches in a web-based questionnaire on a weekly basis.
次要结局
- Adherence to Knee Control+, utilisation fidelity(Reported at follow-up 1 week after the season (November 2025))
- Adherence to Knee Control+, cumulative utilisation(Reported weekly during the 7 months competitive season (April-October 2025))
- Adherence to Knee Control+, utilisation frequency(Reported weekly (coaches) or monthly (players) during the 7 months competitive season (April-October 2025), as well as at follow-up 1 week after the season (November 2025))
- Adherence to Knee Control+, duration fidelity(Reported at follow-up 1 week after the season (November 2025))
- Behavioural outcomes, self-efficacy(Reported by coaches at baseline (March 2025), monthly during the 7 months competitive season (April-October 2025) and follow-up 1 week after the season (November 2025))
- Behavioural outcomes, presence of action plans(Reported at baseline (March 2025) and follow-up 1 week after the season (November 2025), as well as mid-season (August 2025).)
- Behavioural outcomes, presence of coping plans(Reported at mid-season (August 2025) and at follow-up 1 week after the season (November 2025))
- Behavioural outcomes, perception of club support(Reported at follow-up 1 week after the season (November 2025))
- Behavioural outcomes, autonomous and controlled motivation(Reported at baseline (March 2025) and follow-up 1 week after the season (November 2025))
- Behavioural outcomes, basic psychological needs(Reported at mid-season (August 2025) and follow-up 1 week after the season (November 2025))
- Behavioural outcomes, basic need support(Reported at follow-up 1 week after the season (November 2025))
- Injury outcomes, incidence of new injuries(Reported monthly during the 7 months competitive season (intervention period, April-October 2025).)
- Injury outcomes, monthly prevalence of injuries(Reported monthly during the 7 months competitive season (intervention period, April-October 2025).)
- Adverse events(Reported at follow-up 1 week after the season (November 2025))
研究者
Martin Hägglund
Professor
Linkoeping University