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


- candidate number1953
- NTR NumberNTR580
- ISRCTNISRCTN78846684
- Date ISRCTN created8-mrt-2006
- date ISRCTN requested7-mrt-2006
- Date Registered NTR30-jan-2006
- Secondary IDsN/A 
- Public TitleThe prevention of lower extremity physical activity injuries; a school-based randomised controlled trial in children aged 10-12 years.
- Scientific TitleThe prevention of lower extremity physical activity injuries; a school-based randomised controlled trial in children aged 10-12 years.
- ACRONYMiPlay
- hypothesisThe promotion of safe sports participation proves effective in a physical education setting, resulting in a reduction of lower extremity injuries in children.
- Healt Condition(s) or Problem(s) studiedNo condition, healthy person
- Inclusion criteriaPrimary schools.
- Exclusion criteriaN/A
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2006
- planned closingdate30-jul-2007
- Target number of participants2280
- InterventionsThe injury prevention programme aimed 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.
- Primary outcome1. Incidence of lower extremity injuries;
2. Costs associated with lower extremity injuries.
- Secondary outcomeChange in attitudes and behaviour with regards to injury and injury prevention.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMSc. D.M. Collard
- CONTACT for SCIENTIFIC QUERIESMSc. D.M. Collard
- Sponsor/Initiator VU University Medical Center, EMGO-Institute
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryIn children physical activity injuries are a major health problem. Physical activity injuries in children are associated with prolonged periods of impairment of everyday activity and life. In order to reduce the short- and long-term effects of physical activity injuries in terms of their social and economic consequences, prevention of these injuries in children is important. The aim of the proposed randomised controlled trial is to evaluate an intervention programme to be used in physical education (PE) classes of primary schools, aimed at reducing acute lower extremity injuries due to sports and physical activities in pupils aged 10-12 years. The intervention programme has been developed according to the intervention mapping protocol, and is designed to reduce injuries sustained during PE, as well as during organised and non-organised sports and physical activities. The effectiveness of the prevention programme will be evaluated in a randomised controlled trial. The study will be carried out during one school year in primary schools, reaching boys and girls aged 10-12 years (7th & 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 effect of the intervention will be assessed using multilevel analysis. The primary outcome measure will be acute lower extremity injury incidence. Secondary outcome measures will include injury severity, injury costs, school absence and intermediary factors such as knowledge and attitude regarding the prevention of lower extremity injuries.
- Main changes (audit trail)
- RECORD30-jan-2006 - 9-dec-2009


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