Contact information
Type
Scientific
Contact name
Dr D.M. Collard
ORCID ID
Contact details
VU University Medical Center
EMGO-Institute
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
dorine.collard@vumc.nl
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
NTR580
Study information
Scientific title
Acronym
iPlay
Study hypothesis
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
Study design
Randomised active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Prevention
Patient information sheet
Condition
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
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.
Secondary outcome measures
Change 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 date
01/09/2006
Overall study end date
30/07/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Primary schools: boys and girls aged 10 - 12 years.
Participant type(s)
Patient
Age group
Child
Lower age limit
10 Years
Upper age limit
12 Years
Sex
Both
Target number of participants
2280
Participant exclusion criteria
Does not comply with the above inclusion criteria
Recruitment start date
01/09/2006
Recruitment end date
30/07/2007
Locations
Countries of recruitment
Netherlands
Study participating centre
VU University Medical Center
Amsterdam
1081 BT
Netherlands
Sponsor information
Organisation
Vrije University Medical Centre (VUMC) (The Netherlands)
Sponsor details
EMGO Institute
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+31 (0)20 444 8180
emgo@vumc.nl
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 23/11/2010 | Yes | No |