Cost-effectiveness and implementation process of a running-related injury prevention program (RunIn3): Protocol of a randomized controlled trial

Pamela Marinelli Barros, Caio Sain Vallio, Gabriela Martins de Oliveira, Gisela C Miyamoto, Luiz Hespanhol, Pamela Marinelli Barros, Caio Sain Vallio, Gabriela Martins de Oliveira, Gisela C Miyamoto, Luiz Hespanhol

Abstract

Background: Running is one of the most popular and accessible physical activities in the world. However, running-related injuries are unfortunately very common. Scientific evidence is limited and scarce regarding (cost-)effectiveness and implementation process of interventions for running-related injuries prevention. Thus, the objective of this study will be to investigate the effectiveness, cost-effectiveness and implementation process of a running-related injury prevention program (RunIn3).

Methods: This is the protocol of a pragmatic hybrid type 1 randomized controlled trial. There will be 530 runners over 18 years old, without running-related injuries in the last 3 months from São Paulo, Brazil. This program will be delivered online with two broad actions: (1) to provide feedback on individual training characteristics and running-related injury risk; and (2) providing/enhancing knowledge, skills and self-efficacy on running-related injury preventive behaviors. The primary outcome will be the proportion of runners reporting running-related injuries. The secondary outcomes will be preventive behaviors, direct and indirect costs, and implementation outcomes. The main effectiveness analysis on the primary outcome will be performed using linear probability mixed models in order to allow outcome changes over time and to yield the absolute risk reduction between-groups.

Discussion: The main hypothesis of this study is that the RunIn3 program will be effective in reducing the running-related injury risk and in promoting preventive behavior, either by increasing the frequency of healthy behaviors or by reducing the frequency of risk behaviors. Moreover, if the RunIn3 program is effective in reducing the running-related injuries risk, we believe that this effect would go alongside with a reduction of societal costs.

Trail registration: Clinicaltrials.gov (NCT03892239) Registered 5 February 2019 - Prospectively registered, https://ichgcp.net/clinical-trials-registry/NCT03892239.

Keywords: Bayesian analysis; Economic evaluation; Health behavior; Implementation science; Running; Sports injuries.

Conflict of interest statement

The authors declare that they have no competing interest of any nature.

© 2021 The Authors. Published by Elsevier Inc.

Figures

Fig. 1
Fig. 1
Process overview of the study design.

References

    1. Hespanhol Junior L.C., Pillay J.D., van Mechelen W., Verhagen E. Meta-analyses of the effects of habitual running on indices of health in physically inactive adults. Sports Med. 2015;45:1455–1468. doi: 10.1007/s40279-015-0359-y.
    1. Chakravarty E.F., Hubert H.B., Lingala V.B., Fries J.F. Reduced disability and mortality among aging runners: a 21-year longitudinal study. Arch. Intern. Med. 2008;168:1638–1646. doi: 10.1001/archinte.168.15.1638.
    1. Lee D.C., Pate R.R., Lavie C.J., Sui X., Church T.S., Blair S.N. Leisure-time running reduces all-cause and cardiovascular mortality risk. J. Am. Coll. Cardiol. 2014;64:472–481. doi: 10.1016/j.jacc.2014.04.058.
    1. Lavie C.J., D-c Lee, Sui X., Arena R., O'keefe J.H., Church T.S. Effects of running on chronic diseases and cardiovascular and all-cause mortality. Mayo Clin. Proc. 2015;90:1541–1552. doi: 10.1016/j.mayocp.2015.08.001.
    1. Jastrzebski Z., Zychowska M., Radziminski L., Konieczna A., Kortas J. Damage to liver and skeletal muscles in marathon runners during a 100 km run with regard to age and running speed. J. Hum. Kinet. 2015;45:93–102. doi: 10.1515/hukin-2015-0010.
    1. Kim J.H., Malhotra R., Chiampas G., d'Hemecourt P., Troyanos C., Cianca J. Cardiac arrest during long-distance running races. N. Engl. J. Med. 2012;366:130–140. doi: 10.1056/NEJMoa1106468.
    1. Schwabe K., Schwellnus M., Derman W., Swanevelder S., Jordaan E. Medical complications and deaths in 21 and 56 km road race runners: a 4-year prospective study in 65 865 runners–SAFER study I. Br. J. Sports Med. 2014;48:912–918. doi: 10.1136/bjsports-2014-093470.
    1. Hatziandreu E.I., Koplan J.P., Weinstein M.C., Caspersen C.J., Warner K.E. A cost-effectiveness analysis of exercise as a health promotion activity, Am. J. Publ. Health. 1988;78:1417–1421. doi: 10.2105/ajph.78.11.1417.
    1. Hespanhol Junior L.C., van Mechelen W., Postuma E., Verhagen E. Health and economic burden of running-related injuries in runners training for an event: a prospective cohort study. Scand. J. Med. Sci. Sports. 2016;26:1091–1099. doi: 10.1111/sms.12541.
    1. Hespanhol Junior L.C., van Mechelen W., Verhagen E. Health and economic burden of running-related injuries in Dutch trailrunners: a prospective cohort study. Sports Med. 2017;47:367–377. doi: 10.1007/s40279-016-0551-8.
    1. Hespanhol Junior L.C., Pena Costa L.O., Lopes A.D. Previous injuries and some training characteristics predict running-related injuries in recreational runners: a prospective cohort study. J. Physiother. 2013;59:263–269. doi: 10.1016/S1836-9553(13)70203-0.
    1. Hespanhol Junior L.C., Huisstede B.M., Smits D.-W., Kluitenberg B., van der Worp H., van Middelkoop M. The NLstart2run study: economic burden of running-related injuries in novice runners participating in a novice running program. J. Sci. Med. Sport. 2016;19:800–804. doi: 10.1016/j.jsams.2015.12.004.
    1. Videbaek S., Bueno A.M., Nielsen R.O., Rasmussen S. Incidence of running-related injuries per 1000 h of running in different types of runners: a systematic review and meta-analysis, Sports Med. 2015;45:1017–1026. doi: 10.1007/s40279-015-0333-8.
    1. Hespanhol Junior L.C., Costa L.O., Carvalho A.C., Lopes A.D. A description of training characteristics and its association with previous musculoskeletal injuries in recreational runners: a cross-sectional study, Rev. Brasileira Fisioterapia. 2012;16:46–53.
    1. Andrish J.T., Bergfeld J.A., Walheim J. A prospective study on the management of shin splints, J. Bone Joint Surg. Am. 1974;56:1697–1700.
    1. Brushoj C., Larsen K., Albrecht-Beste E., Nielsen M.B., Loye F., Holmich P. Prevention of overuse injuries by a concurrent exercise program in subjects exposed to an increase in training load: a randomized controlled trial of 1020 army recruits. Am. J. Sports Med. 2008;36:663–670. doi: 10.1177/0363546508315469.
    1. Buist I., Bredeweg S.W., Lemmink K.A., Pepping G.J., Zwerver J., van Mechelen W. The GRONORUN study: is a graded training program for novice runners effective in preventing running related injuries? Design of a Randomized Controlled Trial, BMC Musculoskelet Disord. 8. 2007;24 doi: 10.1186/1471-2474-8-24.
    1. Knapik J.J., Brosch L.C., Venuto M., Swedler D.I., Bullock S.H., Gaines L.S. Effect on injuries of assigning shoes based on foot shape in air force basic training. Am. J. Prev. Med. 2010;38:S197–S211. doi: 10.1016/j.amepre.2009.10.013.
    1. Knapik J.J., Swedler D.I., Grier T.L., Hauret K.G., Bullock S.H., Williams K.W. Injury reduction effectiveness of selecting running shoes based on plantar shape. J. Strength Condit Res. 2009;23:685–697. doi: 10.1519/JSC.0b013e3181a0fc63.
    1. Larsen K., Weidich F., Leboeuf-Yde C. Can custom-made biomechanic shoe orthoses prevent problems in the back and lower extremities? A randomized, controlled intervention trial of 146 military conscripts. J. Manip. Physiol. Ther. 2002;25:326–331. doi: 10.1067/mmt.2002.124419.
    1. van Mechelen W., Hlobil H., Kemper H.C., Voorn W.J., de Jongh H.R. Prevention of running injuries by warm-up, cool-down, and stretching exercises. Am. J. Sports Med. 1993;21:711–719. doi: 10.1177/036354659302100513.
    1. Yeung S.S., Yeung E.W., Gillespie L.D. Interventions for preventing lower limb soft-tissue running injuries. Cochrane Database Syst. Rev. 2011 doi: 10.1002/14651858.CD001256.pub2. CD001256.
    1. Bredeweg S.W., Zijlstra S., Bessem B., Buist I. The effectiveness of a preconditioning programme on preventing running-related injuries in novice runners: a randomised controlled trial, Br. J. Sports Med. 2012;46:865–870. doi: 10.1136/bjsports-2012-091397.
    1. Knapik J.J., Trone D.W., Tchandja J., Jones B.H. Injury-reduction effectiveness of prescribing running shoes on the basis of foot arch height: summary of military investigations. J. Orthop. Sports Phys. Ther. 2014;44:805–812. doi: 10.2519/jospt.2014.5342.
    1. Malisoux L., Chambon N., Delattre N., Gueguen N., Urhausen A., Theisen D. Injury risk in runners using standard or motion control shoes: a randomised controlled trial with participant and assessor blinding. Br. J. Sports Med. 2016;50:481–487. doi: 10.1136/bjsports-2015-095031.
    1. Bartholomew L.K., Parcel G.S., Kok G. Intervention mapping: a process for developing theory- and evidence-based health education programs. Health Educ. Behav. 1998;25:545–563. doi: 10.1177/109019819802500502.
    1. Eldredge L.K.B., Markham C.M., Ruiter R.A., Fernández M.E., Kok G., Parcel G.S. John Wiley & Sons; 2016. Planning Health Promotion Programs: an Intervention Mapping Approach.
    1. Verhagen E.A., van Stralen M.M., Van Mechelen W. Behaviour, the key factor for sports injury prevention. Sports Med. 2010;40:899–906. doi: 10.2165/11536890-000000000-00000.
    1. Hespanhol L.C., Jr., van Mechelen W., Verhagen E. Effectiveness of online tailored advice to prevent running-related injuries and promote preventive behaviour in Dutch trail runners: a pragmatic randomised controlled trial. Br. J. Sports Med. 2018;52:851–858. doi: 10.1136/bjsports-2016-097025.
    1. Collard D.C., Chinapaw M.J., Van Mechelen W. Design of the iPlay study. Sports Med. 2009;39:889–901. doi: 10.2165/11317880-000000000-00000.
    1. Gielen A.C., Sleet D. Application of behavior-change theories and methods to injury prevention. Epidemiol. Rev. 2003;25:65–76. doi: 10.1093/epirev/mxg004.
    1. Adriaensens L., Hesselink A., Fabrie M., Brugmans M., Verhagen E. Effectiveness of an online tailored intervention on determinants and behaviour to prevent running related sports injuries: a randomised controlled trial. Schweizerische Zeitschrift für Sportmedizin und Sporttraumatologie. 2014;62:6–13.
    1. Verhagen E.A., Clarsen B., Bahr R. A peek into the future of sports medicine: the digital revolution has entered our pitch, Br. J. Sports Med. 2014;48:739–740. doi: 10.1136/bjsports-2013-093103.
    1. Fokkema T., de Vos R.-J., van Ochten J.M., Verhaar J.A., Davis I.S., Bindels P.J. Online multifactorial prevention programme has no effect on the number of running-related injuries: a randomised controlled trial. Br. J. Sports Med. 2019;53:1479–1485. doi: 10.1136/bjsports-2018-099744.
    1. Barth R. Home-based reinforcement of school behavior: a review and analysis. Rev. Educ. Res. 1979;49:436–458. doi: 10.3102/00346543049003436.
    1. Strohacker K., Galarraga O., Williams D.M. The impact of incentives on exercise behavior: a systematic review of randomized controlled trials. Ann. Behav. Med. 2014;48:92–99. doi: 10.1007/s12160-013-9577-4.
    1. Twisk J. Sample size calculations. In: Twisk J.W.R., editor. Applied Longitudinal Data Analysis for Epidemiology: A Practical Guide. 2 ed ed. Cambridge University Press; Cambridge: 2013. pp.237–42.
    1. Twisk J. Sample-size calculations. In: Twisk J.W.R., editor. Applied Mixed Model Analysis: A Practical Guide. 2 ed ed. Cambridge University Press; Cambridge: 2019. pp. p.179–86.
    1. Verhagen E. Prevention of running-related injuries in novice runners: are we running on empty? Br. J. Sports Med. 2012;46:836–837. doi: 10.1136/bjsports-2012-091505.
    1. Hespanhol Junior L.C., Barboza S.D., van Mechelen W., Verhagen E. Measuring sports injuries on the pitch: a guide to use in practice. Braz. J. Phys. Ther. 2015;19:369–380. doi: 10.1590/bjpt-rbf.2014.0110.
    1. RCT, R: a language and environment for statistical computing. R Found. Statist. Comput. 2019 Vienna, Austria. URL
    1. Ritterband L.M., Gonder-Frederick L.A., Cox D.J., Clifton A.D., West R.W., Borowitz S.M. Internet Intervent.: In review, in use, and into the future, Professional Psychology: Research and Practice. 2003;34:527–534. doi: 10.1037/0735-7028.34.5.527.
    1. Andersson G. Internet interventions: past, present and future. Internet Intervent. 2018;12:181–188. doi: 10.1016/j.invent.2018.03.008.
    1. Glanz K., Rimer B.K., Viswanath K. 2015. Health Behavior: Theory, Research, and Practice: John Wiley & Sons.
    1. Higgins J., Thomas J., Chandler J., Cumpston M., Li T., Page M. Cochrane Handbook for systematic reviews of interventions version 6.0 (updated July 2019) Cochrane. 2019 Available from:
    1. Pimenta R., Lopes A. 2017. Tradução, Adaptção Transcultural e Análise das Propriedade de Medidas da Versão Portugês-Brasileira do Oslo Sports Trauma Research Center - Questionnaire On Health Problems.
    1. Clarsen B., Ronsen O., Myklebust G., Florenes T.W., Bahr R. The Oslo Sports Trauma Research Center questionnaire on health problems: a new approach to prospective monitoring of illness and injury in elite athletes, Br. J. Sports Med. 2014;48:754–760. doi: 10.1136/bjsports-2012-092087.
    1. Clarsen B., Myklebust G., Bahr R. Development and validation of a new method for the registration of overuse injuries in sports injury epidemiology: the Oslo Sports Trauma Research Centre (OSTRC) overuse injury questionnaire. Br. J. Sports Med. 2013;47:495–502. doi: 10.1136/bjsports-2012-091524.
    1. Ajzen I. 2005. Attitudes, Personality, and Behavior: McGraw-Hill Education (UK)
    1. Ajzen I. The theory of planned behavior. Organ. Behav. Hum. Decis. Process. 1991;50:179–211. doi: 10.1016/0749-5978(91)90020-t.
    1. Ajzen I., Madden T.J. Prediction of goal-directed behavior: attitudes, intentions, and perceived behavioral control. J. Exp. Soc. Psychol. 1986;22:453–474. doi: 10.1016/0022-1031(86)90045-4.
    1. McKay C.D., Verhagen E. 'Compliance' versus 'adherence' in sport injury prevention: why definition matters. Br. J. Sports Med. 2016;50:382–383. doi: 10.1136/bjsports-2015-095192.
    1. Proctor E., Silmere H., Raghavan R., Hovmand P., Aarons G., Bunger A. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm. Pol. Ment. Health. 2011;38:65–76. doi: 10.1007/s10488-010-0319-7.
    1. Hellevik O. Linear versus logistic regression when the dependent variable is a dichotomy. Qual. Quantity. 2009;43:59–74.
    1. Robins J.M., Greenland S. Identifiability and exchangeability for direct and indirect effects. Epidemiology. 1992;3:143–155. doi: 10.1097/00001648-199203000-00013.
    1. VanderWeele T.J., Vansteelandt S. Conceptual issues concerning mediation, interventions and composition. Stat. Interface. 2009;2:457–468. doi: 10.4310/sii.2009.v2.n4.a7.
    1. Huang R. 2017. RQDA: R-Based Qualitative Data Analysis, R Package Version 0.3-0.
    1. van Dongen J.M., van Wier M.F., Tompa E., Bongers P.M., van der Beek A.J., van Tulder M.W. Trial-based economic evaluations in occupational health: principles, methods, and recommendations. J. Occup. Environ. Med. 2014;56:563–572. doi: 10.1097/JOM.0000000000000165.
    1. Alfaro M.E., Zoller S., Lutzoni F. Bayes or bootstrap? A simulation study comparing the performance of bayesian Markov chain Monte Carlo sampling and bootstrapping in assessing phylogenetic confidence. Mol. Biol. Evol. 2003;20:255–266. doi: 10.1093/molbev/msg028.
    1. Rubin D.B. John Wiley & Sons; 2004. Multiple Imputation for Nonresponse in Surveys.
    1. Sterne J.A., White I.R., Carlin J.B., Spratt M., Royston P., Kenward M.G. Multiple imputation for missing data in epidemiological and clinical research: potential and pitfalls. BMJ. 2009;338 doi: 10.1136/bmj.b2393. b2393.
    1. Fenwick E., O'Brien B.J., Briggs A. Cost-effectiveness acceptability curves–facts, fallacies and frequently asked questions. Health Econ. 2004;13:405–415.

Source: PubMed

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

3
S'abonner