Pan African Clinical Trials Registry

South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201505001045388 Date of Approval: 21/02/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title SOCCER INJURY SURVEILLANCE AND IMPLEMENTATION OF AN INJURY PREVENTION PROGRAMME IN RWANDA
Official scientific title EFFECT OF THE FIFA 11+ WARM UP PROGRAMME ON THE INCIDENCE OF INJURIES IN SOCCER CLUBS IN RWANDA
Brief summary describing the background and objectives of the trial In Rwanda a large number of young people participate in soccer at different levels. Players incur injuries as they increase their involvement in soccer. As mentioned by Junge and Dvorak (2004) players sustain performance limiting injuries every year. Players in Rwanda may have serious problems with their performance that may be due to the severity of injuries and extended period of time without playing. Therefore many players may not have the opportunity to proceed to high performance and top level play. Injury prevention has been advocated to help players to stay injury-free by proper training, warm up, cool down, stretching and adequate recovery (Kirkendall, Junge, & Dvorak, 2010; Colin Fuller, Junge, & Dvorak, 2012). Additionally a study conducted in Rwanda shows the need for preventive measures as soccer players are threatened by the reduction of their performance and stop their careers at an early stage due to injuries (Twizere, 2004). Coaches and players should be aware and take the lead to minimize the risk for injuries and follow appropriate treatment and rehabilitation principles. However, coaches and players may have deficits in the knowledge and implementation of injury prevention measures. Moreover, teams may be experiencing insufficient financial resources and shortage of medical personnel. There is a need for injury prevention intervention programmes targeting coaches to address injuries in youth soccer in Rwanda. OBJECTIVES a.To assess if there is any difference in the occurrence of injuries before and after the introduction of the FIFA 11+ warm up programme b.To assess if the compliance of the injury prevention warm up programme will be associated with the reduction injuries. c.To determine if there is a difference in injury incidence between the groups (I vs C)
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning,soccer injuries
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/04/2015
Actual trial start date 01/06/2015
Anticipated date of last follow up 30/06/2016
Actual Last follow-up date 30/06/2016
Anticipated target sample size (number of participants) 434
Actual target sample size (number of participants) 434
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised This is a cluster randomisation where the soccer clubs will be the unit of randomisation. Soccer clubs will be represented by numbers. They will be allocated to the intervention or control group using simple random technique. A blinded person will pick the numbers to allocate them in two groups. After group allocation the coin tossing will be the decider for the allocation of the group to either the intervention or the control group Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group A comprehensive warm up programme/ FIFA 11+ warm up programme 20 minutes warm up exercises to be performed at least 3 times a week before training or match 1 competitive season/ 10 months Coaches will be instructed on the 15 evidence-based exercises and the promotion of Fair Play during training. On field practical demonstration will also be conducted. At the end of the training, each coach will receive a DVD and a booklet for reference 217
Control Group usual warm up programme usual warm up programme before each training and match the duration of the training is not measured for the control group no intervention in the control group 217 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Head, assistants and goalkeeper coaches of the teams in the second division clubs Players who have contracts and licenses of teams enrolled to play in the second division Players and coaches who will not agree to participate in the study. Players with preexisting injuries will be excluded 18 Year(s) 35 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 18/09/2014 Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Observatory 7925 Cape Town South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Reduction of the incidence in soccer injuries The occurrence of injuries will be recorded as they happen by the medical personnel of the teams as well as training and match exposure. All the records will be handed to the researcher on weekly basis. The analysis will be done at the end of the study.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federation Rwandaise de Football Association Kigali BP 2000 Kigali Rwanda
FUNDING SOURCES
Name of source Street address City Postal code Country
Government of Rwanda through the Embassy 983 Schoeman Street, Arcadia Pretoria 55224 Arcadia 0007 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Government of Rwanda through the Embassy 983 Schoeman Street, Arcadia Pretoria 55224 Arcadia 0007 South Africa Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Dr. Theresa Gurgess Observatory 7925 Cape Town South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Theresa Burgess theresa.burgess@uct.ac.za +27 21 406 6171 Anzio Road
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Deputy Head Res, Snr Lecturer, Div Physior, Dept Health Rehab Sci, Faculty Health Sciences, UCT
Role Name Email Phone Street address
Public Enquiries Nuhu Assuman Nuhu.Assuman@gmail.com +27810729728 Anzio Road
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Student
Role Name Email Phone Street address
Scientific Enquiries Jennifer Jelsma jennifer.jelsma@uct.ac.za +27 21 406 6595 Anzio Road
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Head Postgrad Educ, Dept Health Rehab Sciences, Faculty Health Sciences, UCT
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial phase 06/07/2018 PACTR UPDATE Not Applicable
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 02/03/2015 Changed to correspond to the number of participants in both the intervention group and the control group 217 434
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Disease(s) 06/07/2018 PACTR UPDATE Other Injury, Occupational Diseases, Poisoning, Other