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.: PACTR201608001730223 Date of Approval: 27/07/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation of the Effectiveness and Implementation of the BokSmart Safe Six Injury Prevention Program
Official scientific title Evaluation of the Effectiveness and Implementation of the BokSmart Safe Six Injury Prevention Program
Brief summary describing the background and objectives of the trial Rugby Union has a high incidence and severity of injury. This high burden of injury, has led to the development of many injury prevention interventions aimed at coach and referee education. For example, SmartRugby and RugbySmart are interventions based in Australia and New Zealand, which formed the conceptual basis for South Africa¿s nationwide injury prevention program, BokSmart. The overall goal of these interventions is to reduce rugby¿s injury burden. The ¿BokSmart Safe Six¿ exercises were selected and developed from the evidence in the literature, using principles of best-practice and clinical knowledge. The ¿BokSmart Safe Six¿ exercises target the body locations identified as being associated with the highest injury burden in rugby: knee, hamstring, lower limb, ankle and shoulder. The ¿BokSmart Safe Six¿ exercises aim to reduce this injury through improving strength, joint stability, balance and control of these areas. However, the exercises were also designed to maximise both efficacy and effectiveness (real-world implementation) and thus also considered potential implementation barriers. As such, the BokSmart Safe Six were designed to form part of a regular team warm-up, to not require equipment, and to take less than 10 minutes to complete. The BokSmart Safe Six study aims to: 1. Evaluate the effectiveness of the BokSmart Safe Six exercise program on injury rates and injury risk profiles of Under 16 male rugby players prior to and after using the BokSmart Safe Six 2. Evaluate how the BokSmart Safe Six exercises are being implemented within the school context, while examining aspects of exercise quality, including fidelity 3. Determine the barriers and facilitators to the implementation of the BokSmart Safe Six in the schoolboy rugby setting
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Rugby Injuries
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/03/2017
Actual trial start date
Anticipated date of last follow up 31/12/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 320
Actual target sample size (number of participants)
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
Parallel: different groups receive different interventions at same time during study Randomised coin-tossing Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group BokSmart Safe Six 3 times a week 18 weeks six exercises 160
Control Group Control none 18 weeks no intervention, continue as per usual 160 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Players must represent the 2016 Under 16 A or B schoolboy rugby squad in a team in the Western Province Rugby Union School¿s Premier League. Between the age of 14-16 years old Players must be injury free for six months prior to the study Every playe cleared by their personal medical professional No written consent from their parent and assent from themselves 14 Year(s) 16 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 11/03/2016 Human Research Ethics Committee of the University of Cape Town
Ethics Committee Address
Street address City Postal code Country
Groote Schuur Hospital, Observatory, 7925 Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Musculoskeletal tests Prior to beginning 9 weeks into the trial 18 weeks (at the end) after the beginning of the trial
Secondary Outcome Injury Rates Throughout the trial, as a player gets injured.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Division of Exercise Science and Sports Medicine, University of Cape Town Boundary Road Cape Town 7700 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
BokSmart, South African Rugby Union N1 City Cape Town 7460 South Africa
National Research Foundation Meiring Naude Road Pretoria 0081 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Prof Mike Lambert Boundary Road Cape Town 7700 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Dr James Brown Boundary Road Cape Town 7700 South Africa
Dr Evert Verhagen Vrije University Amsterdam 1081 Netherlands
Prof Willem van Mechelen Vrije University Amsterdam 1081 Netherlands
Prof Mike Lambert Boundary Road Cape Town 7700 South Africa
Nicola Sewry Boundary Road Cape Town 7700 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mike Lambert mike.lambert@uct.ac.za 0216504558 Division of Exercise Science and Sports Medicine, University of Cape Town
City Postal code Country Position/Affiliation
Cape Town 7700 South Africa Professor
Role Name Email Phone Street address
Public Enquiries Nicola Sewry nicolasewry@hotmail.com 0846181753 Division of Exercise Science and Sports Medicine, University of Cape Town
City Postal code Country Position/Affiliation
Cape Town 7700 South Africa PhD Candidate
Role Name Email Phone Street address
Scientific Enquiries Nicola Sewry nicolasewry@hotmail.com 0846181753 Division of Exercise Science and Sports Medicine, University of Cape Town
City Postal code Country Position/Affiliation
Cape Town 7700 South Africa PhD Candidate
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information