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
Secondary identifying numbers NTR580
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

Study designRandomised active controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typePrevention
Scientific title
Study acronymiPlay
Study objectivesThe 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) studiedNo condition, healthy person
InterventionThe 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 typeOther
Primary outcome measure1. Incidence of lower extremity injuries
2. Costs associated with lower extremity injuries

Primary and secondary outcomes measured September/October 2006 and June/July 2007.
Secondary outcome measuresChange in attitudes and behaviour with regards to injury and injury prevention. Primary and secondary outcomes measured September/October 2006 and June/July 2007.
Overall study start date01/09/2006
Completion date30/07/2007

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit10 Years
Upper age limit12 Years
SexBoth
Target number of participants2280
Key inclusion criteriaPrimary schools: boys and girls aged 10 - 12 years.
Key exclusion criteriaDoes not comply with the above inclusion criteria
Date of first enrolment01/09/2006
Date of final enrolment30/07/2007

Locations

Countries of recruitment

  • Netherlands

Study participating centre

VU University Medical Center
Amsterdam
1081 BT
Netherlands

Sponsor information

Vrije University Medical Centre (VUMC) (The Netherlands)
Hospital/treatment centre

EMGO Institute
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Phone +31 (0)20 444 8180
Email emgo@vumc.nl
Website http://www.vumc.nl/
ROR logo "ROR" https://ror.org/00q6h8f30

Funders

Funder type

Research organisation

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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