The prevention of lower extremity physical activity injuries: a school-based randomised controlled trial in children aged 10 - 12 years

ISRCTN	ISRCTN78846684
DOI	https://doi.org/10.1186/ISRCTN78846684
Protocol serial number	NTR580
Sponsor	Vrije University Medical Centre (VUMC) (The Netherlands)
Funder	The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Submission date: 08/03/2006
Registration date: 08/03/2006
Last edited: 15/08/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr D.M. Collard
Scientific

VU University Medical Center
EMGO-Institute
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Email	dorine.collard@vumc.nl

Study information

Primary study design	Interventional
Study design	Randomised active controlled parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	iPlay
Study objectives	The promotion of safe sports participation proves effective in a physical education setting, resulting in a reduction of lower extremity injuries in children. Please note that as of 19/12/2008 the anticipated start and end dates in this record were amended. The previous dates are as follows: Initial anticipated start date: 01/10/2005 Initial anticipated end date: 01/10/2008
Ethics approval(s)	The Medical Ethics Committee of Vrije University Medical Centre approved the study design, protocols and informed consent procedures on 6th July 2006
Health condition(s) or problem(s) studied	No condition, healthy person
Intervention	The study will be carried out during one school year in primary schools, reaching boys and girls aged 10 - 12 years (7th and 8th grade). Schools will serve as randomisation units to avoid spill-over of the intervention within schools and to enhance control over intervention adherence and compliance. The injury prevention programme aimed at lower extremity injuries in children aged 10 - 12 years was constructed based on an intervention mapping protocol. In general the injury prevention programme focuses on injury prevention in general and focuses on injury awareness, physical fitness and coordination (motor control). In addition the programme focuses on soccer, tennis, basketball, inline skating and snowboarding. These are the most commonly practiced activities in this age group. The injury prevention programme will be given by the children's teachers as a 9 month course.
Intervention type	Other
Primary outcome measure(s)	1. Incidence of lower extremity injuries 2. Costs associated with lower extremity injuries Primary and secondary outcomes measured September/October 2006 and June/July 2007.
Key secondary outcome measure(s)	Change in attitudes and behaviour with regards to injury and injury prevention. Primary and secondary outcomes measured September/October 2006 and June/July 2007.
Completion date	30/07/2007

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	10 Years
Upper age limit	12 Years
Sex	All
Target sample size at registration	2280
Key inclusion criteria	Primary schools: boys and girls aged 10 - 12 years.
Key exclusion criteria	Does not comply with the above inclusion criteria
Date of first enrolment	01/09/2006
Date of final enrolment	30/07/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

VU University Medical Center

Amsterdam
1081 BT
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	23/11/2010		Yes	No