NCT05137015

Brief Summary

Football is the most popular sport in the world, with 260 million male and female active participants, including \~113,000 FIFA registered professional players. Playing football is fun and can provide many health benefits, however, it also presents a high injury risk. Studies on elite and non-elite footballers have reported similar injury rates in both genders. The most common football-related injuries are the knee and ankle ligament and thigh muscle strains, Over the past two decades, significant advancement has been made in the field of injury prevention in football. There are used trials to prevent specific injuries, as ankle sprain, ACL injuries, hamstring strains, etc. On the other hand, there are created programs designed to prevent a wider spectrum of injuries like FIFA11+. Therefore, the aim of this study is to investigate the effect of a new injury prevention program on the overall injury incidence in young football players.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,027

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

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

Study Start

First participant enrolled

September 4, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 30, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2023

Completed
Last Updated

April 20, 2023

Status Verified

April 1, 2023

Enrollment Period

9 months

First QC Date

November 18, 2021

Last Update Submit

April 19, 2023

Conditions

Injury Prevention

Outcome Measures

Primary Outcomes (1)

  • Overall injury rate

    up to 9 months

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention group will use the new injury prevention program at least twice per week in their training sessions.

Other: Injury prevention program

Control

NO INTERVENTION

The control group will continue their usual training routine.

Interventions

Injury prevention programOTHER

The execution of the program takes 10-15 minutes. The program will be performed in the training sessions, after the usual warm-up. The program is based on scientific evidence that has previously shown good efficacy on injury prevention in football. The exercise categories address 7 aspects: 1. Balance 2. Core stability 3. Hamstring eccentrics 4. Glute activation 5. Plyometrics 6. Running 7. Games The games are included with the aim to increase the attractiveness of the program. Each category contains 2 exercises and the coach is free to decide which one to choose in every training session. All exercises are organized in five or six levels with increasing difficulty (physically and cognitively).

Intervention

Eligibility Criteria

Age13 Years - 19 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • officially registered football club in the football federation of Kosovo players must be between 13-19 years old regular training must take place at least three times per week

You may not qualify if:

  • teams already using an injury prevention program injured players

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Gjakova

Gjakova, Kosovo

Location

Related Publications (2)

  • Obertinca R, Meha R, Hoxha I, Shabani B, Meyer T, Aus der Funten K. Impact of the 'FUNBALL' Programme on Severe Injuries Among Young Male Football Players: A Secondary Analysis from a Cluster-Randomised Controlled Trial. Sports Med Open. 2025 Nov 27;11(1):151. doi: 10.1186/s40798-025-00945-3.

    PMID: 41310111DERIVED

  • Obertinca R, Meha R, Hoxha I, Shabani B, Meyer T, Aus der Funten K. Efficacy of a new injury prevention programme (FUNBALL) in young male football (soccer) players: a cluster-randomised controlled trial. Br J Sports Med. 2024 May 2;58(10):548-555. doi: 10.1136/bjsports-2023-107388.

    PMID: 38499320DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Two teams will work on injury data collection. Teams are not informed for which group (intervention or control) they are recording the datas.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Cluster randomised controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2021

First Posted

November 30, 2021

Study Start

September 4, 2021

Primary Completion

May 29, 2022

Study Completion

January 21, 2023

Last Updated

April 20, 2023

Record last verified: 2023-04

Locations

KO(1)