Enhancing Prevention of Injuries in Community Youth and Adult Amateur Football Players

NCT06748443 | Recruiting

• 1 other identifier: 2024-07394-01
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 1

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. 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. 2.Does coach self-efficacy to use Knee Control+, player motivation and player training dosage differ between the intervention and control groups?
3. 3.What are the mediators and moderators that influence use of Knee Control+?
4. 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. 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. 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?

Conditions

Injury Prevention in Sports; Adherence

Keywords

amateur sports; injury prevention exercise programme; adherence; co-design; support for coaches

Outcome Measures

Primary Outcomes (1)

• Use of Knee Control+

  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.

  One season, 7 months, from start of the competitive season (April 2025) to the end of the competitive season (October 2025)

Secondary Outcomes (14)

• 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)

• Adherence to Knee Control+, utilisation 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)

Other Outcomes (13)

• Process evaluation, number of teams that participate in physical workshops

  Reported at follow-up 1 week after the season (November 2025)

• Process evaluation, number of teams that participate in site visits

  Reported at follow-up 1 week after the season (November 2025)

• Process evaluation, number of teams that participate in booster workshops

  Reported at follow-up 1 week after the season (November 2025)

Study Arms (2)

Intervention group receiving support for implementation of Knee Control+

EXPERIMENTAL

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: 1. physical and digital workshops aiming to increase coach self-efficacy and formalisation of action and coping plans, 2. site visits to their teams by a study designated fitness coach, aiming to increase coach self-efficacy and player autonomous motivation, 3. digital programme material with films aiming to increase coach knowledge and inspiration to use Knee Control+, 4. leaflets about Knee Control+ as inspiration and reminder to use the programme, 5. social media support as reminder to use the programme. Site visits and physical workshops will be led by specifically trained fitness coaches.

Behavioral: Support intervention for the use of Knee Control+; Other: Information about Knee Control+

Control group with standard introduction of Knee Control+

ACTIVE COMPARATOR

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.

Other: Information about Knee Control+

Interventions

Support intervention for the use of Knee Control+ BEHAVIORAL

Coaches will be offered a smorgasbord of support interventions that they can choose from depending on their specific needs: physical and digital workshops before and during the study, site visits to their team, digital programme material, leaflets and social media posts. Fitness coaches will be responsible for physical workshops to train the football coaches.

Also known as: Knee Control+, Injury prevention exercise programme

Intervention group receiving support for implementation of Knee Control+

Information about Knee Control+ OTHER

Coaches receive information about injuries in football and the efficacy of injury prevention exercise programmes at a pre-season digital workshop, and guided to access the Knee Control+ programme from the Swedish Football Association website.

Control group with standard introduction of Knee Control+; Intervention group receiving support for implementation of Knee Control+

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Linkoeping University: lead
• The Swedish Research Council: collaborator
• the Swedish Research Council for Health, Working Life and Welfare: collaborator

Study Sites (1)

Linköping university

Linköping, Sweden

RECRUITING

Related Publications (1)

• Lindblom H, Sonesson S, Walden M, Akerlund I, Ivarsson A, Hagglund M. Enhancing Prevention of Injuries in Community youth and adult amateur football teams (EPIC) via implementation support for an exercise-based intervention: study protocol for a type 3 hybrid implementation-effectiveness cluster-randomised controlled trial. BMJ Open. 2025 Aug 26;15(8):e102008. doi: 10.1136/bmjopen-2025-102008.

  PMID: 40858379 DERIVED

Study Officials

• Martin Hägglund, Professor

  Linköping university, Department of Health, Medicine and Caring Sciences, Unit of Physiotherapy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Hägglund, Professor

CONTACT

+4613-281388; martin.hagglund@liu.se

Hanna Lindblom, PhD

CONTACT

+4613284784; hanna.lindblom@liu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Type 3 hybrid cluster randomised controlled trial

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 27, 2024
• Study Start: March 25, 2025
• Primary Completion: November 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1 year after publication
• Access Criteria: De-identified individual participant data that underlie results in publications may be available upon reasonable request to the principal investigator

Locations

SE (1)