NCT04272047

Brief Summary

This is a three-armed intervention study that evaluates the injury preventive effects of three different training interventions in youth and adult football players. Two intervention arms are randomized and one arm acts as a non-randomized comparison group. Half of randomized participants will receive a general injury prevention exercise program with emphasis on the lower extremities, and the other half a hip/groin focused injury prevention exercise. A third group of participants who already use an injury prevention exercise program at study inclusion are invited to participate as a non-randomized comparison group and continue their usual training practices.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
548

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

March 30, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

April 7, 2022

Status Verified

April 1, 2022

Enrollment Period

8 months

First QC Date

February 10, 2020

Last Update Submit

April 6, 2022

Conditions

Keywords

Prevention

Outcome Measures

Primary Outcomes (1)

  • All physical complaints injury in four main locations

    Any football related injury occurring to the ankle, knee, hamstrings and hip/groin, regardless of need of care or absence from football training or matches ("all physical complaints" injury definition)

    Study start up to end of season (7 months)

Secondary Outcomes (14)

  • All physical complaints injury

    Study start up to end of season (7 months)

  • Time-loss injury

    Study start up to end of season (7 months)

  • Medical attention injury

    Study start up to end of season (7 months)

  • Acute or gradual onset injury

    Study start up to end of season (7 months)

  • Substantial injury

    Study start up to end of season (7 months)

  • +9 more secondary outcomes

Study Arms (3)

Knee Control+

EXPERIMENTAL

Knee Control+ consists of 6 different exercises, with 10 different variations/progressions, and takes 10-15 minutes to complete. In addition, teams are instructed to perform a 5-minute running warm-up before the Knee Control+ exercises. Teams are to carry out the running warm-up and Knee Control+ at all training sessions, and the running warm-up before all matches, during the whole season. Knee Control+ is based on the Knee Control program but with more variations for each exercise making it easier to tailor for the needs in the respective teams.

Other: Knee Control+ program

Adductor strengthening program

EXPERIMENTAL

The Adductor strengthening program consists of a single exercise with three levels of difficulty. The exercise is based on the Copenhagen Adduction exercise. Teams are to carry out the Adductor strengthening program as part of their regular warm-up 2-3 times per week, one set per side, during the pre-season, and 1 time per week, one set per side during the in-season.

Other: Adductor strengthening program

Knee Control

ACTIVE COMPARATOR

Teams will carry on their normal training and warm-up routines using the Knee Control program with no intervention from the researchers. Knee Control consists of 6 different exercises, with 4 different variations/progressions and 1 pair-exercise.

Other: Knee Control program

Interventions

15-20 minute training program to be performed as per the team's usual routines (no intervention from the researchers).

Knee Control

Adductor strengthening program to be performed 2-3 times per week, one set per side, during the pre-season, and 1 time per week, one set per side during the in-season.

Adductor strengthening program

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Teams participating in youth or adult league series in the 2020 football season. All players in the eligible teams will be invited to participate (players from the age of 14 and older, born 2006 or earlier)
  • Teams who have not used a structured training program aiming to prevent injuries that resembles the 3 intervention arms (e.g. the Knee Control program, Knee Control+ program, 11+ program, Adductor strengthening program) on a regular basis the last year
  • Teams who have scheduled training at least twice per week
  • Teams participating in youth or adult league series in the 2020 football season. All players in the eligible teams will be invited to participate (players from the age of 14 and older, born 2006 or earlier)
  • Teams who have used the Knee Control program on a regular basis the last year, but no other structured training program aiming to prevent injuries (e.g. the Knee Control+ program, 11+ program, Adductor strengthening program)
  • Teams who have scheduled training at least twice per week

You may not qualify if:

  • Teams who have used a structured groin injury prevention exercise program (e.g. Adductor strengthening program, Hölmich protocol) on a regular basis the last year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linköping University

Linköping, 58183, Sweden

Location

Related Publications (4)

  • Lindblom H, Akerlund I, Walden M, Sonesson S, Hagglund M. Players are positive regarding injury prevention exercise programmes, but coaches need ongoing support: a survey-based evaluation using the Health Action Process Approach model across one season in amateur and youth football. BMJ Open Sport Exerc Med. 2024 Jun 24;10(2):e002009. doi: 10.1136/bmjsem-2024-002009. eCollection 2024.

  • Sonesson S, Lindblom H, Hagglund M. Higher age and present injury at the start of the season are risk factors for in-season injury in amateur male and female football players-a prospective cohort study. Knee Surg Sports Traumatol Arthrosc. 2023 Oct;31(10):4618-4630. doi: 10.1007/s00167-023-07517-6. Epub 2023 Aug 5.

  • Lindblom H, Walden M, Hagglund M. Adherence to Injury Prevention Exercise Programmes in Amateur Adolescent and Adult Football: A Detailed Description of Programme Use from a Randomised Study. Sports Med Open. 2023 Jul 15;9(1):57. doi: 10.1186/s40798-023-00608-1.

  • Lindblom H, Sonesson S, Torvaldsson K, Walden M, Hagglund M. Extended Knee Control programme lowers weekly hamstring, knee and ankle injury prevalence compared with an adductor strength programme or self-selected injury prevention exercises in adolescent and adult amateur football players: a two-armed cluster-randomised trial with an additional comparison arm. Br J Sports Med. 2023 Jan;57(2):83-90. doi: 10.1136/bjsports-2022-105890. Epub 2022 Oct 31.

MeSH Terms

Conditions

Athletic Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Martin Hägglund, Professor

    Linkoeping University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Physiotherapists who assess injuries are blinded to group belonging. Statistician performing outcome analyses are blinded to group belonging.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This is a three-armed intervention study that evaluates the injury preventive effects of three different training interventions in youth and adult football players. Two intervention arms are randomized and one arm acts as a non-randomized comparison group.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 10, 2020

First Posted

February 17, 2020

Study Start

March 30, 2020

Primary Completion

November 30, 2020

Study Completion

December 31, 2020

Last Updated

April 7, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

Individual participant data may be available upon reasonable request to the principal investigator

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Preliminary in autumn 2020
Access Criteria
Study protocol and statistical analysis plan is planned to be submitted in writing to an open access scientific journal

Locations