Condition category
Injury, Occupational Diseases, Poisoning
Date applied
21/12/2017
Date assigned
16/02/2018
Last edited
16/02/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Youth football has similar injury problems to adult football, and injuries should therefore be considered a problem. An injury to a youth footballer could be detrimental to their ambitions and even worse, make them drop out of organized sports. However, research has shown that it is possible to reduce the rate of injuries in youth football. For example, the FIFA 11+ has shown a large reduction in overall injuries. However, prevention interventions in football have to date focused almost exclusively on interventions designed to alter intrinsic modifiable risk factors, for example through a structured warm up. Although training load seems to be highly associated with injury risk, no intervention has to date investigated training load management. The aim of this study is to investigate the effect of a training load progression model on injuries in elite youth footballers.

Who can participate?
Male and female footballers aged 15-19 from one of the top three tiers in Norwegian Junior football

What does the study involve?
The participating teams are randomly allocated to either the intervention group or the control group. Teams in the intervention group conduct training based on a load progression model. The control group is asked to continue normal training activity.

What are the possible benefits and risks of participating?
The knowledge gained will be of use to researchers, doctors and coaching staff working with all team sports. This program have no side effects and there is no potential risk involved in participating in the study. The total duration of intervention and follow-up is 11 months. The percentage of players reporting a health issue is measured using a questionnaire via text message on the last Sunday of each month.

Where is the study run from?
Oslo Sports Trauma Research Center (Norway)

When is the study starting and how long is it expected to run for?
January 2018 to November 2018

Who is funding the study?
Oslo Sports Trauma Research Center (Norway)

Who is the main contact?
Torstein Dalen
torstein.dalen@nih.no

Trial website

http://www.nih.no/forskning/prosjekter/forskningsprosjekter-ved-nih/styring-av-treningsbelastning-for-reduksjon-av-skader-og-sykdom-i-fotball/

Contact information

Type

Public

Primary contact

Mr Torstein Dalen

ORCID ID

Contact details

Sognsveien 220
Oslo
0863
Norway
+47 (0)93841844
torstein.dalen@gmail.com

Type

Scientific

Additional contact

Mr Torstein Dalen

ORCID ID

Contact details

Sognsveien 220
Oslo
0863
Norway
+47 (0)93841844
torstein.dalen@nih.no

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

93841844

Study information

Scientific title

Training load management to reduce injuries in elite youth football: a cluster randomised controlled trial

Acronym

Study hypothesis

Individual training load management can reduce risk of injuries among elite youth footballers.

Ethics approval

The Norwegian School of Sciences Ethics Board, 21/12/2017, ref: 39-191217

Study design

Single-center cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Risk of injuries among elite youth footballers

Intervention

The trialists will cluster randomise on a team level. A computer-generated block randomisation will be performed, with block sizes of 4 and 6 in random order. After a team agrees to participate, the principal investigator will open a sealed envelope revealing their group assignment.

The teams will be randomly allocated to either the intervention group (18 teams, 300 players) or the control group (18 teams, 300 players). Intervention group coaches will be given access to a digital tool for training load management. The coaches will plan their player's training weeks based on a progression model. The control group is asked to continue normal training activity. The total duration of intervention and follow-up is 11 months.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Prevalence of health problems (percentage of players reporting a health issue), collected using the Oslo Sports Trauma Research Center Questionnaire via an SMS system on the last Sunday of each month

Secondary outcome measures

Incidence of injuries, collected through previously reported method (https://www.ncbi.nlm.nih.gov/pubmed/27034126) where the teams provide all time-loss injuries and illnesses

Overall trial start date

01/01/2018

Overall trial end date

30/11/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Elite youth footballers competing in one of the three highest levels
2. Both genders
3. Aged 15-19

Participant type

Healthy volunteer

Age group

Other

Gender

Both

Target number of participants

600

Participant exclusion criteria

Unable to communicate in Scandinavian language

Recruitment start date

15/01/2018

Recruitment end date

25/01/2018

Locations

Countries of recruitment

Norway

Trial participating centre

Norwegian School of Sports Sciences
0863
Norway

Sponsor information

Organisation

Norwegian School of Sport Sciences

Sponsor details

Department of Sports Medicine
Sognsveien 220
Oslo
0863
Norway
+47 (0)23 26 20 00
postmottak@nih.no

Sponsor type

University/education

Website

www.nih.no

Funders

Funder type

Research organisation

Funder name

Oslo Sports Trauma Research Center

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes