Clinical trial NCT06748443: Enhancing Prevention of Injuries in Community Youth and Adult Amateur Football Players
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Injury Prevention in Sports
Adherence
Keywords: amateur sports
injury prevention exercise programme
adherence
co-design
support for coaches
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
Collaborators: name: The Swedish Research Council
name: the Swedish Research Council for Health, Working Life and Welfare
First posted: 2024-12-27
Enrollment: 1600
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Type 3 hybrid cluster randomised controlled trial
Primary purpose: PREVENTION

Brief summary: 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

1. 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?
2. Does coach self-efficacy to use Knee Control+, player motivation and player training dosage differ between the intervention and control groups?
3. What are the mediators and moderators that influence use of Knee Control+?
4. How well do the intervention and control groups adhere to Knee Control+ recommended use and is there an association between adherence and preventive efficacy?
5. 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)?
6. 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.

Detailed description: 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.

Both group constellations have mainly been active during the planning for the study, but some participants may also be invited to give their view on the results and the interpretation of results after the 2025 season. After the 2025 season and potentially before upscaling of the study, the workshop strategies will be followed-up with the fitness coach association and evaluate whether any changes are needed before opening up for national dissemination.

Data will be collected primarily through web-based questionnaires covering implementation outcomes, behavioural outcomes, injury outcomes, adverse events, as well as a process evaluation.

Sample size calculations for the primary outcome were completed using the Shiny CRT online tool for binary outcomes, based on a logistic regression model. Calculations assumed 3 teams per cluster (club); a coefficient of variation equal to 0.9 was applied to account for variation in cluster sizes. An exchangeable correlation structure was assumed, and base case calculations used an intracluster correlation (ICC) of 0.02. Sensitivity analyses considered ICC values between 0.01 and 0.05. The estimated proportion of weeks where teams use the Knee Control+ in the CG is 0.5 (50%), and in the IG 0.8 (80%) based on published data. Considering a design effect (DE) of 1.04, a cluster size of 3 teams will allow for detection of a between-group difference in the primary outcome of at least 0.3 (30%) with 80% power at the 5% level of statistical significance, with total 29 clusters (85 teams). For the same difference in outcome, varying the ICC results between 0.01 and 0.05 rendered sample sizes between 28-30 clusters (83-90 teams). Therefore, the aim is to include minimum 90 teams.

For the main injury outcome, ≥7 days time-loss injuries (secondary outcome), sample size calculations were completed based on a Poisson regression model using the Shiny CRT online tool. Calculations assumed 15 players per team (cluster in the secondary analysis), a coefficient of variation equal to 0.9 was applied to account for variation in cluster sizes. An exchangeable correlation structure was assumed, and base case calculations used an intracluster correlation (ICC) of 0.02. Sensitivity analyses considered ICC values between 0.01 and 0.05. The estimated injury incidence in the CG is 0.2 (20%), and in the IG 0.1 (10%) based on published data. Considering a design effect (DE) of 1.28, a cluster size of 15 players will allow detection of a between-group relative difference in the secondary outcome of at least 0.5 (50% injury reduction) with 80% power at the 5% level of statistical significance, with total 41 teams (607 players). For the same difference in outcome, varying the ICC results between 0.01 and 0.05 rendered sample sizes between 37-54 teams (541-806 players). This equals to total 14 clusters (range 12-18 clusters) at a club level.

Data on any football related injury will be collected regardless of need of care or absence from football training or matches ("all physical complaints" injury definition).

The primary outcome, use of Knee Control+, will be analysed at team-level as the proportion of weeks with sufficient use of the programme and compared between intervention group and control group using logistic regression. The limit for sufficient training frequency is set at Knee Control+ training at least 2 times per week. Since a gradual start of injury prevention training is preferred for beginners, for players 10-12 years use of ≥3 of 6 main exercises is deemed sufficient, whereas for players \>12 years, use of ≥4 of 6 main exercises is deemed sufficient to be defined as use of Knee Control+. Other measures of implementation will also be compared between groups and predominantly with parametric statistics.

Injury incidence rate (injuries per 1000 athlete exposures) and monthly prevalence rate (number of injured athletes/total number of athletes each month) will be presented with 95% confidence intervals, and incidence rate ratio and prevalence rate ratio will be calculated and compared between groups (according to intention-to-treat) using Generalized Linear Models with Poisson distribution, log link and the natural logarithm of total athlete exposures or total eligible weeks as offset denominator variables.

Qualitative interviews will be analysed using qualitative content analysis and an inductive approach.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Players with long-term injuries not planning to take part in match play in the 2025 season

Primary outcomes:
measure: Use of Knee Control+
timeFrame: One season, 7 months, from start of the competitive season (April 2025) to the end of the competitive season (October 2025)
Secondary outcomes:
measure: Adherence to Knee Control+, cumulative utilisation
timeFrame: Reported weekly during the 7 months competitive season (April-October 2025)
measure: Adherence to Knee Control+, utilisation frequency
timeFrame: 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)
measure: Adherence to Knee Control+, duration fidelity
timeFrame: Reported at follow-up 1 week after the season (November 2025)
measure: Adherence to Knee Control+, utilisation fidelity
timeFrame: Reported at follow-up 1 week after the season (November 2025)
measure: Behavioural outcomes, self-efficacy
timeFrame: 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)
measure: Behavioural outcomes, presence of action plans
timeFrame: Reported at baseline (March 2025) and follow-up 1 week after the season (November 2025), as well as mid-season (August 2025).
measure: Behavioural outcomes, presence of coping plans
timeFrame: Reported at mid-season (August 2025) and at follow-up 1 week after the season (November 2025)
measure: Behavioural outcomes, perception of club support
timeFrame: Reported at follow-up 1 week after the season (November 2025)
measure: Behavioural outcomes, autonomous and controlled motivation
timeFrame: Reported at baseline (March 2025) and follow-up 1 week after the season (November 2025)
measure: Behavioural outcomes, basic psychological needs
timeFrame: Reported at mid-season (August 2025) and follow-up 1 week after the season (November 2025)
measure: Behavioural outcomes, basic need support
timeFrame: Reported at follow-up 1 week after the season (November 2025)
measure: Injury outcomes, incidence of new injuries
timeFrame: Reported monthly during the 7 months competitive season (intervention period, April-October 2025).
measure: Injury outcomes, monthly prevalence of injuries
timeFrame: Reported monthly during the 7 months competitive season (intervention period, April-October 2025).
measure: Adverse events
timeFrame: Reported at follow-up 1 week after the season (November 2025)
Other outcomes:
measure: Process evaluation, number of teams that participate in physical workshops
timeFrame: Reported at follow-up 1 week after the season (November 2025)
measure: Process evaluation, number of teams that participate in site visits
timeFrame: Reported at follow-up 1 week after the season (November 2025)
measure: Process evaluation, number of teams that participate in booster workshops
timeFrame: Reported at follow-up 1 week after the season (November 2025)
measure: Process evaluation, number of teams that participate in digital workshops
timeFrame: Reported at follow-up 1 week after the season (November 2025)
measure: Process evaluation, number of teams that use printed programme material
timeFrame: Reported at follow-up 1 week after the season (November 2025)
measure: Process evaluation, number of teams that use digital programme material
timeFrame: Reported at follow-up 1 week after the season (November 2025)
measure: Process evaluation, number of teams that use social media account
timeFrame: Reported at follow-up 1 week after the season (November 2025)
measure: Process evaluation, number of teams that use Knee Control+ material via the Swedish Football Association
timeFrame: Reported at follow-up 1 week after the season (November 2025)
measure: Process evaluation, perceptions of the support intervention (quantitative)
timeFrame: Reported at follow-up 1 week after the season (November 2025), and immediately after taking part in workshops or site visits during the 7 months competitive season (April-October 2025)
measure: Process evaluation, perceptions of the support intervention (qualitative)
timeFrame: Reported in qualitative sub-study after the season (November 2025-March 2026)
measure: Process evaluation, web statistics
timeFrame: Assessed throughout the study (from pre-season March 2025, competitive season April-October 2025, until follow-up 1 week after the season in November 2025)
measure: Process evaluation, club prevention policies and practices
timeFrame: Reported at follow-up 1 week after the season (November 2025)
measure: Process evaluation, perceptions about the education of coaches
timeFrame: Reported at follow-up 1 week after the season (November 2025)
Locations:
city: Linköping
country: Sweden
facility: Linköping university
Study officials:
affiliation: Linköping university, Department of Health, Medicine and Caring Sciences, Unit of Physiotherapy
name: Martin Hägglund, Professor
role: PRINCIPAL_INVESTIGATOR
References: