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Design of a Randomised Controlled Trial BMJ Open Sport Exerc Med: first published as 10.1136/bmjsem-2020-000780 on 16 June 2020. Downloaded from Open access Protocol Enhanced injury prevention programme for recreational runners (the SPRINT study): design of a randomised controlled trial Tryntsje Fokkema ,1 Robert- Jan de Vos,2 Edwin Visser,3 Patrick Krastman,1,4 John IJzerman,5 Bart W Koes,1,6 Jan A N Verhaar,2 Sita M A Bierma- Zeinstra,1,2 Marienke van Middelkoop1 To cite: Fokkema T, ABSTRACT running one of the top three sports with the de Vos R- J, Visser E, et al. Introduction Running- related injuries (RRIs) are most reported injuries.3 More than half of Enhanced injury prevention frequent, but no effective injury prevention measures programme for recreational these RRIs required medical treatment. Also runners (the SPRINT study): have been identified yet. Therefore, we have set up the the number of RRIs per 1000 training hours design of a randomised INSPIRE trial in 2017, in which the effectiveness of an is high. In 2018, there were 6.3 injuries per online injury prevention programme was tested. Although controlled trial. BMJ Open 1000 training hours in running compared Sport & Exercise Medicine this programme was not effective in reducing the number 2020;6:e000780. doi:10.1136/ with 3.4 injuries per 1000 training hours of all of RRIs, we gained new insights from this study, which 3 bmjsem-2020-000780 we used to design an enhanced, online multidisciplinary sports together. These numbers emphasise injury prevention programme. The aim of this study is to the need for injury prevention in recreational runners. Accepted 24 May 2020 test the effectiveness of this enhanced injury prevention programme in a group of recreational runners. Risk factors for RRIs were assessed in Methods and analysis For this randomised controlled multiple studies. A large variety of risk factors by copyright. trial, we aim to include 3394 recreational runners aged 18 were identified in the past decades (eg, over- years or older who register for a running event (distances weight, previous injuries and a high weekly 10 to 42.2 km). During the preparation for the running running distance).4 5 This indicates that the event, runners in the intervention group get access to the cause of RRIs is multifactorial. However, enhanced online injury prevention programme. This online most prevention studies focussed on modi- programme consists of 10 steps, all covering separate 6–8 © Author(s) (or their items of RRI prevention. Runners in the control group fying one single risk factor for RRIs. For employer(s)) 2020. Re- use will follow their regular preparation. With three follow- up example, Bredeweg et al performed an permitted under CC BY. questionnaires (1 month before, 1 week before and 1 month randomised controlled trial (RCT) aiming at Published by BMJ. http://bmjopensem.bmj.com/ after the running event), the proportions of self- reported 1 the risk factor ‘no previous experience with Department of General Practice, RRIs in the intervention group and the control group are sporting activities with axial loading’ and Erasmus MC Medical University compared. Center, Rotterdam, The offered novice runners a preconditioning 9 Netherlands Ethics and dissemination An exemption for a programme. No effect on the number of 2Department of Orthopaedics, comprehensive application has been obtained by the RRIs was found. Also in other RCTs on RRI Medical Ethical Committee of the Erasmus MC University Erasmus MC Medical University prevention in which one risk factor for RRIs Center, Rotterdam, The Medical Center, Rotterdam, the Netherlands. The results Netherlands of the study will be disseminated among the running (eg, increasing training load too fast or 3Department of Physiotherapy, population, published in peer- reviewed international performing no warming- up) was targeted, no 6 8 Sport Medical Center journals and presented on international conferences. effect on the number of RRIs was found. We 'Sportgeneeskunde Rotterdam', Trial registration number NL7694 hypothesised that this ineffectiveness may be on September 27, 2021 by guest. Protected Rotterdam, The Netherlands due to the fact that these studies targeted only 4Rotterdam Marathon Study Group, Rotterdam, The one single risk factor for RRIs, while the cause Netherlands of RRIs seems to be multifactorial. There- 5Dutch Athletic Federation, INTRODUCTION fore, we have set up the INSPIRE trial in Arnhem, The Netherlands 2017, a randomised controlled trial in which 6 Running is a popular sport. In the Nether- Center for Muscle and Joint lands, it is practiced by over 2 million people we tested the effectiveness of a multifacto- Health, University of Southern Denmark, Odense, Denmark (approximately 12.5% of the Dutch popula- rial online injury prevention programme in tion).1 Running has many positive effects on 2378 recreational runners.10 This programme both physical and mental health.2 However, consisted of information on evidence- based Correspondence to Dr Marienke van Middelkoop; the injury rates in running are high. In 2018, risk factors for RRIs and advices to reduce m. vanmiddelkoop@ erasmusmc. there were 750 000 running-related injuries injury risk. However, with an injury propor- nl (RRIs) in the Netherlands, which makes tion of 37.5% in the intervention group Fokkema T, et al. BMJ Open Sp Ex Med 2020;6:e000780. doi:10.1136/bmjsem-2020-000780 1 BMJ Open Sport Exerc Med: first published as 10.1136/bmjsem-2020-000780 on 16 June 2020. Downloaded from Open access and 36.7% in the control group, this programme was not effective in reducing the number of RRIs (OR 1.08; 95% CI 0.90 to 1.29).11 Although the injury prevention programme of the INSPIRE trial was not effective, some interesting and new insights were gained.11 For example, it appeared that the multifactorial online prevention programme seemed to have a negative effect on the occurrence of RRIs in runners with no injury history.11 Furthermore, the results showed that runners who applied the information from the biomechanics section of the prevention programme to their training seemed to have an increased injury risk compared with those who did not use this information.11 We assume this is the result of the advice on stride pattern. These findings indicate that research on RRI prevention should probably specifically aim at runners who had RRIs in the past. Moreover, advices on stride pattern should not be presented through a website, since this seems to Figure 1 Flowchart of the SPRINT (Shaping up have negative impact on injury occurrence. Probably Preventionfor Running Injuries in the Netherlands using changes to stride pattern should only be made under Tensteps) study. supervision of a trainer or physiotherapist.12 Participants of the INSPIRE trial indicated that ‘not knowing what to do’ was an important barrier for injury prevention and Participants the participants wished to integrate the injury prevention Potential participants are runners who register for the measures into their training sessions.13 This indicates following running events; DSW Bruggenloop Rotterdam that injury prevention advices should be directive and 2019 (15 km), Nacht van Groningen 2020 (10, 16.1 personalised. and 21.1 km), NN CPC Loop The Hague 2020 (10 and by copyright. Therefore, we designed an enhanced, online multi- 21.1 km) and NN Marathon Rotterdam 2020 (10.55 and disciplinary injury prevention programme entitled 42.195 km). On the online registration forms of these ‘10 steps 2 outrun injuries’. The primary aim of this running events a question is included, in which the study is to test the effectiveness of this injury preven- runners are asked whether they are interested in partic- ipating in a research project on the prevention of RRIs. tion programme on the number of RRIs in recreational Contact information of interested runners is send to the runners. researchers, who will subsequently send more informa- tion about the study to these runners. Runners who are METHODS still interested in participation are asked to provide elec- http://bmjopensem.bmj.com/ Study design tronic informed consent and can immediately fill out the The Shaping up Prevention for Running Injuries in the baseline questionnaire. Netherlands using Ten steps (SPRINT) study is a RCT Only runners aged 18 years or older who register in recreational runners who are participating in running for one of the aforementioned five running events events in the Netherlands. Half of the participants can participate in the SPRINT study. Exclusion criteria of the SPRINT study will get access to the prevention include participation in our previous trial on RRI preven- programme during the preparation for a running event, tion (INSPIRE trial), registration for the running event while the other half of the participants will follow their less than 2 months before the event, no access to internet and/or email and no proper knowledge of the Dutch regular preparation for the event. The preparations on September 27, 2021 by guest. Protected language. For runners who register for multiple running for the SPRINT study started in December 2018 and in events, only the first registration is taken into account. August 2019 the first participants are included. The data collection is finalised in May 2020 and the first results are Randomisation expected by the end of 2020. The flowchart of the design After completing the baseline questionnaire, the partici- is shown in figure 1. pants are randomised into either the intervention group The SPRINT study is funded by the Netherlands Organ- or the control group. The randomisation is performed isation for Health Research and Development (ZonMW, in Microsoft Access with a block size of 40. The randomi- grant number 50-53600-98-104), and is performed in sation table is generated by an individual from outside collaboration with the Rotterdam Marathon Study Group the research group and this table is not accessible for of Golazo Sports, the organiser of large running events the researchers during the inclusion and data collection.
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