Condition category
Not Applicable
Date applied
08/03/2006
Date assigned
08/03/2006
Last edited
15/08/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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 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

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

Trial setting

Not specified

Trial 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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/09/2006

Overall trial end date

30/07/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Primary schools: boys and girls aged 10 - 12 years.

Participant type

Patient

Age group

Child

Gender

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

Trial 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

http://www.vumc.nl/

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/21092316

Publication citations

  1. Results

    Collard DC, Chinapaw MJ, Verhagen EA, van Mechelen W, Process evaluation of a school based physical activity related injury prevention programme using the RE-AIM framework., BMC Pediatr, 2010, 10, 86, doi: 10.1186/1471-2431-10-86.

Additional files

Editorial Notes