Rationale and design of a Scale-Up Project Evaluating Responsiveness to Home Exercise And Lifestyle Tele-Health (SUPER-HEALTH) in people with physical/mobility disabilities: a type 1 hybrid design effectiveness trial

James H Rimmer, Tapan Mehta, Jereme Wilroy, Byron Lai, Hui-Ju Young, Yumi Kim, Dorothy Pekmezi, Mohanraj Thirumalai, James H Rimmer, Tapan Mehta, Jereme Wilroy, Byron Lai, Hui-Ju Young, Yumi Kim, Dorothy Pekmezi, Mohanraj Thirumalai

Abstract

Introduction: Rates of physical inactivity among people with physical disabilities are substantially higher than in the general population and access to home-based tailored exercise programmes is almost non-existent. Using a theory-driven eHealth platform, an innovative exercise programme referred to as movement-to-music (M2M) will be delivered as a customised, home-based exercise intervention for adults with mobility disabilities.

Methods and analysis: Participants are being recruited for this type 1 hybrid design based effectiveness trial through outpatient clinics at a large rehabilitation centre and randomised to one of three groups: (1) M2M, (2) M2M plus social networking (M2Mplus) and (3) attention control (AC). The intervention includes a 12-week adoption phase, 12-week transition phase and 24-week maintenance phase, at which the collection of objective measures on exercise, fitness and self-reported measures on health will be obtained at the start of each phase and at follow-up. The study compares the effectiveness of M2M and M2Mplus in increasing physical activity (primary outcome), adherence, fitness and physical functioning compared with the AC group and examines the mediators and moderators of the treatment effect.

Ethics and dissemination: The Institutional Review Board of The University of Alabama at Birmingham granted full approval: (IRB-160923002). Dissemination of findings will include publication in peer-reviewed journals, presentations at regional, national and/or international meetings, and the National Center on Health, Physical Activity and Disability (NCHPAD, www.nchpad.org). This study will strengthen our understanding of the potential benefits of eHealth exercise interventions for people with physical disabilities and build on strategies that aim to recruit larger samples in exercise trials.

Trial registration number: NCT03024320; Pre-results.

Keywords: eHealth; humans; mHealth; physical activity; physically disabled.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.

Figures

Figure 1
Figure 1
Study flow chart. M2M, movement-to-music.

References

    1. Lai B, Cederberg K, Vanderbom KA, et al. . Characteristics of adults with neurologic disability recruited for exercise trials: a secondary analysis. Adapt Phys Activ Q 2018;35:476–97. 10.1123/apaq.2017-0109
    1. Chen AY, Kim SE, Houtrow AJ, et al. . Prevalence of obesity among children with chronic conditions. Obesity 2010;18:210–3. 10.1038/oby.2009.185
    1. Fox MH, Witten MH, Lullo C. Reducing obesity among people with disabilities. J Disabil Policy Stud 2014;25:175–85. 10.1177/1044207313494236
    1. Froehlich-Grobe K, Lee J, Washburn RA. Disparities in obesity and related conditions among Americans with disabilities. Am J Prev Med 2013;45:83–90. 10.1016/j.amepre.2013.02.021
    1. Hsieh K, Rimmer JH, Heller T. Obesity and associated factors in adults with intellectual disability. J Intellect Disabil Res 2014;58:851–63. 10.1111/jir.12100
    1. Liou TH, Pi-Sunyer FX, Laferrère B. Physical disability and obesity. Nutr Rev 2005;63:321–31. 10.1111/j.1753-4887.2005.tb00110.x
    1. Rimmer JH, Wang E. Obesity prevalence among a group of Chicago residents with disabilities. Arch Phys Med Rehabil 2005;86:1461–4.
    1. Rimmer JH, Wang E, Yamaki K, et al. . Documenting disparities in obesity and disability, 2010.
    1. Carroll DD, Courtney-Long EA, Stevens AC, et al. . Vital signs: disability and physical activity--United States, 2009-2012. MMWR Morb Mortal Wkly Rep 2014;63:407–13.
    1. Ravesloot C, Seekins T, Young Q-R. Health promotion for people with chronic illness and physical disabilities: the connection between health psychology and disability prevention. Clin Psychol Psychother 1998;5:76–85. 10.1002/(SICI)1099-0879(199806)5:2<76::AID-CPP156>;2-5
    1. Rejeski WJ, Focht BC. Aging and physical disability: on integrating group and individual counseling with the promotion of physical activity. Exerc Sport Sci Rev 2002;30:166–70. 10.1097/00003677-200210000-00005
    1. Rejeski WJ, Brawley LR, Haskell WL. The prevention challenge: an overview of this supplement. Am J Prev Med 2003;25(3 Suppl 2):107–9.
    1. Rimmer JH, Riley B, Creviston T, et al. . Exercise training in a predominantly African-American group of stroke survivors. Med Sci Sports Exerc 2000;32:1990–6. 10.1097/00005768-200012000-00004
    1. Martin Ginis KA, Ma JK, Latimer-Cheung AE, et al. . A systematic review of review articles addressing factors related to physical activity participation among children and adults with physical disabilities. Health Psychol Rev 2016;10:478–94. 10.1080/17437199.2016.1198240
    1. Becker H, Stuifbergen A. What makes it so hard? Barriers to health promotion experienced by people with multiple sclerosis and polio. Fam Community Health 2004;27:75–85. 10.1097/00003727-200401000-00008
    1. Scelza WM, Kalpakjian CZ, Zemper ED, et al. . Perceived barriers to exercise in people with spinal cord injury. Am J Phys Med Rehabil 2005;84:576–83. 10.1097/01.phm.0000171172.96290.67
    1. Phillips M, Flemming N, Tsintzas K. An exploratory study of physical activity and perceived barriers to exercise in ambulant people with neuromuscular disease compared with unaffected controls. Clin Rehabil 2009;23:746–55. 10.1177/0269215509334838
    1. Zalewski K. Exploring barriers to remaining physically active: a case report of a person with multiple sclerosis. J Neurol Phys Ther 2007;31:40–5. 10.1097/01.NPT.0000260570.69863.da
    1. Clarke P, Ailshire JA, Bader M, et al. . Mobility disability and the urban built environment. Am J Epidemiol 2008;168:506–13. 10.1093/aje/kwn185
    1. Vasudevan V, Rimmer JH, Kviz F. Development of the barriers to physical activity questionnaire for people with mobility impairments. Disabil Health J 2015;8:547–56. 10.1016/j.dhjo.2015.04.007
    1. Groah SL, Charlifue S, Tate D, et al. . Spinal cord injury and aging: challenges and recommendations for future research. Am J Phys Med Rehabil 2012;91:80–93. 10.1097/PHM.0b013e31821f70bc
    1. Rimmer JH. Exercise and physical activity in persons aging with a physical disability. Phys Med Rehabil Clin N Am 2005;16:41–56. 10.1016/j.pmr.2004.06.013
    1. Webb TL, Joseph J, Yardley L, et al. . Using the internet to promote health behavior change: a systematic review and meta-analysis of the impact of theoretical basis, use of behavior change techniques, and mode of delivery on efficacy. J Med Internet Res 2010;12:e4 10.2196/jmir.1376
    1. Cuijpers P, van Straten A, Andersson G. Internet-administered cognitive behavior therapy for health problems: a systematic review. J Behav Med 2008;31:169–77. 10.1007/s10865-007-9144-1
    1. Rimmer JH, Lai B, Young HJ. Bending the Arc of Exercise and Recreation Technology Toward People With Disabilities. Arch Phys Med Rehabil 2016;97(9 Suppl):S247–51. 10.1016/j.apmr.2016.02.029
    1. Lai B, Kim Y, Wilroy J, et al. . Sustainability of exercise intervention outcomes among people with disabilities: a secondary review. Disabil Rehabil 2018:1–12. 10.1080/09638288.2018.1432704
    1. Chan AW, Tetzlaff JM, Altman DG, et al. . SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013;158:200–7. 10.7326/0003-4819-158-3-201302050-00583
    1. Hoffmann TC, Glasziou PP, Boutron I, et al. . Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ 2014;348:g1687 10.1136/bmj.g1687
    1. Schulz KF, Altman DG, Moher D. CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c332 10.1136/bmj.c332
    1. Bernet AC, Willens DE, Bauer MS. Effectiveness-implementation hybrid designs: implications for quality improvement science. Implementation Science 2013;8(Suppl 1):S2 10.1186/1748-5908-8-S1-S2
    1. Curran GM, Bauer M, Mittman B, et al. . Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care 2012;50:217–26. 10.1097/MLR.0b013e3182408812
    1. Lindblad AS, Zingeser P, Sismanyazici-Navaie N. Incentives and barriers to neurological clinical research participation. Clin Investig 2011;1:1663–8. 10.4155/cli.11.153
    1. Harris PA, Taylor R, Thielke R, et al. . Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009;42:377–81. 10.1016/j.jbi.2008.08.010
    1. Garber CE, Blissmer B, Deschenes MR, et al. . American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc 2011;43:1334–59. 10.1249/MSS.0b013e318213fefb
    1. Ferguson B. ACSM’s Guidelines for exercise testing and prescription 9th Ed. 2014. J Can Chiropr Assoc 2014;58:328–28.
    1. Kietzmann JH, Hermkens K, McCarthy IP, et al. . Social media? Get serious! Understanding the functional building blocks of social media. Business Horizons 2011;54:241–51. 10.1016/j.bushor.2011.01.005
    1. Ellis T, Motl RW. Physical activity behavior change in persons with neurologic disorders: overview and examples from Parkinson disease and multiple sclerosis. J Neurol Phys Ther 2013;37:85–90. 10.1097/NPT.0b013e31829157c0
    1. Bandura A. Social foundations of thought and action: a social cognitive theory. Englewood Cliffs, NJ: Prentice Hall, 1986.
    1. Bandura A. Health promotion by social cognitive means. Health Educ Behav 2004;31:143–64. 10.1177/1090198104263660
    1. Bandura A. Self-efficacy: The exercise of control. New York, NY, US: W H Freeman/Times Books/Henry Holt & Co, 1997.
    1. Maher C, Ferguson M, Vandelanotte C, et al. . A Web-Based, Social Networking Physical Activity Intervention for Insufficiently Active Adults Delivered via Facebook App: Randomized Controlled Trial. J Med Internet Res 2015;17:e174 10.2196/jmir.4086
    1. Maher CA, Lewis LK, Ferrar K, et al. . Are health behavior change interventions that use online social networks effective? A systematic review. J Med Internet Res 2014;16:e40 10.2196/jmir.2952
    1. Befort CA, Donnelly JE, Sullivan DK, et al. . Group versus individual phone-based obesity treatment for rural women. Eat Behav 2010;11:11–17. 10.1016/j.eatbeh.2009.08.002
    1. Quality of Life Assessment for Physical Activity and Health Promotion: Further Psychometrics and Comparison of Measures. Measurement in Physical Education and Exercise Science 1997;29:36–8. 10.1080/1091367X.2015.1050102
    1. Rimmer JH, Rauworth A, Wang E, et al. . A randomized controlled trial to increase physical activity and reduce obesity in a predominantly African American group of women with mobility disabilities and severe obesity. Preventive Medicine 2009;48:473–9. 10.1016/j.ypmed.2009.02.008
    1. Rimmer JH, Wang E, Pellegrini CA, et al. . Telehealth weight management intervention for adults with physical disabilities: a randomized controlled trial. Am J Phys Med Rehabil 2013;92:1084–94. 10.1097/PHM.0b013e31829e780e
    1. Froehlich-Grobe K, White GW. Promoting physical activity among women with mobility impairments: a randomized controlled trial to assess a home- and community-based intervention 1 1No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit upon the author(s) or upon any organization with which the author(s) is/are associated. Archives of Physical Medicine and Rehabilitation 2004;85:640–8. 10.1016/j.apmr.2003.07.012
    1. Froehlich-Grobe K, Lee J, Aaronson L, et al. . Exercise for everyone: a randomized controlled trial of project workout on wheels in promoting exercise among wheelchair users. Arch Phys Med Rehabil 2014;95:20–8. 10.1016/j.apmr.2013.07.006
    1. Button KS, Ioannidis JP, Mokrysz C, et al. . Power failure: why small sample size undermines the reliability of neuroscience. Nat Rev Neurosci 2013;14:365 10.1038/nrn3475
    1. Bailar JC, Mosteller F. Guidelines for statistical reporting in articles for medical journals. Amplifications and explanations. Ann Intern Med 1988;108:266–73.
    1. Saville DJ. Multiple comparison procedures: the practical solution. The American Statistician 1990;44:174–80. 10.2307/2684163
    1. Saville DJ. Multiple comparison procedures—cutting the gordian knot. Agronomy Journal 2015;107:730–5. 10.2134/agronj2012.0394
    1. Burnham K P, Anderson D R. Multimodel Inference: understanding AIC and BIC in Model Selection. Sociological Methods & Research 2004;33:261–304. 10.1177/0049124104268644
    1. Burnham KAD. Model selection and multimodel inference: a practical information-theoretic approach. 2 edn: Springer-Verlag, 2002.
    1. Rimmer JH, Riley B, Wang E, et al. . Physical activity participation among persons with disabilities: barriers and facilitators. Am J Prev Med 2004;26:419–25. 10.1016/j.amepre.2004.02.002
    1. Salisbury SK, Choy NL, Nitz J. Shoulder pain, range of motion, and functional motor skills after acute tetraplegia. Arch Phys Med Rehabil 2003;84:1480–5.
    1. Rimmer JH. The conspicuous absence of people with disabilities in public fitness and recreation facilities: lack of interest or lack of access? Am J Health Promot 2005;19:327–9. 10.4278/0890-1171-19.5.327
    1. Rimmer JH, Padalabalanarayanan S, Malone LA, et al. . Fitness facilities still lack accessibility for people with disabilities. Disabil Health J 2017;10:214–21. 10.1016/j.dhjo.2016.12.011
    1. Cook KF, Molton IR, Jensen MP. Fatigue and aging with a disability. Arch Phys Med Rehabil 2011;92:1126–33. 10.1016/j.apmr.2011.02.017
    1. Wanner M, Martin-Diener E, Bauer G, et al. . Comparison of trial participants and open access users of a web-based physical activity intervention regarding adherence, attrition, and repeated participation. J Med Internet Res 2010;12:e3 10.2196/jmir.1361
    1. Jaarsma EA, Dijkstra PU, Geertzen JH, et al. . Barriers to and facilitators of sports participation for people with physical disabilities: a systematic review. Scand J Med Sci Sports 2014;24:871–81. 10.1111/sms.12218
    1. Rimmer JH, Rubin SS, Braddock D. Barriers to exercise in African American women with physical disabilities. Arch Phys Med Rehabil 2000;81:182–8. 10.1016/S0003-9993(00)90138-2
    1. Rimmer JH, Silverman K, Braunschweig C, et al. . Feasibility of a health promotion intervention for a group of predominantly African American women with type 2 diabetes. Diabetes Educ 2002;28:571–80. 10.1177/014572170202800411
    1. Rimmer JH, Wang E, Smith D. Barriers associated with exercise and community access for individuals with stroke. J Rehabil Res Dev 2008;45:315–22. 10.1682/JRRD.2007.02.0042
    1. Norman CD, Skinner HA. eHEALS: the eHealth literacy scale. J Med Internet Res 2006;8:e27 10.2196/jmir.8.4.e27
    1. Brooke J. SUS-A quick and dirty usability scale Jordan PW, Thomas PW, McClelland PW, Weerdmeester PW, Usability Evaluation In Industry. Taylor & Francis, 1996:189–94.
    1. Stoyanov SR, Hides L, Kavanagh DJ, et al. . Mobile app rating scale: a new tool for assessing the quality of health mobile apps. JMIR Mhealth Uhealth 2015;3:e27 10.2196/mhealth.3422

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