Physical activity promotion for patients transitioning to dialysis using the "Exercise is Medicine" framework: a multi-center randomized pragmatic trial (EIM-CKD trial) protocol

Ram Jagannathan, Susan Lynn Ziolkowski, Mary Beth Weber, Jason Cobb, Nhat Pham, Jin Long, Shuchi Anand, Felipe Lobelo, Ram Jagannathan, Susan Lynn Ziolkowski, Mary Beth Weber, Jason Cobb, Nhat Pham, Jin Long, Shuchi Anand, Felipe Lobelo

Abstract

Background: Patients on dialysis are physically inactive, with most reporting activity levels below the fifth percentile of healthy age-matched groups. Several small studies have reported efficacy of diverse exercise interventions among persons with CKD and those on dialysis. However, no single intervention has been widely adopted in real-world practice, despite a clear need in this vulnerable population with high rates of mortality, frailty, and skilled nursing hospitalizations.

Methods/design: We describe a pragmatic clinical trial for an exercise intervention among patients transitioning to dialysis. We will use an existing framework - Exercise is Medicine (EIM) - developed by the American College of Sports Medicine. After undertaking formative qualitative research to tailor the EIM framework to the advanced CKD population (eGFR < 30 ml/min/1.73m2), we will randomize 96 patients from two regions-Atlanta and Bay Area-in two intervention arms with incremental levels of clinical-community integration: physical activity assessment during Nephrology clinical visit, brief counseling at pre-dialysis education, and physical activity wearable (group 1) versus group 1 intervention components plus a referral to a free, EIM practitioner-led group exercise program over 16 weeks (group 2; 8 week core intervention; 8-week follow up). We will assess efficacy by comparing between group differences in minutes/week of objectively measured moderate intensity physical activity. To evaluate implementation, we will use questionnaires for assessing barriers to referral, participation and retention along the path of the intervention. Further we will have a plan for dissemination of the intervention by partnering with relevant stakeholders.

Discussion: The overall goal is to inform the development of a practical, cost-conscious intervention "package" that addresses barriers and challenges to physical activity commonly faced by patients with advanced CKD and can be disseminated amongst interested practices.

Trial registration: ClinicalTrials.gov identifier (Dated:10/17/2017): NCT03311763 .

Keywords: Chronic kidney disease; Estimated glomerular filteration rate; Exercise is medicine; Intervention; Physical activity; Qualitative interviews.

Conflict of interest statement

Ethics approval and consent to participate

The trial has been approved by the institutional review boards of Stanford (IRB Registration #: 43198) and Emory University (IRB#: IRB00099894). Oral and written informed consent to participation will be obtained from all study participants by study personnel prior to any study related procedure. All participants receive both written and oral information about the study before consenting. Any modifications to the protocol which may impact on the conduct of the study, including changes of study objectives, study design, patient population, sample sizes, study procedures, or significant administrative aspects will require a formal amendment to the protocol and approved by the ethical review board of Stanford and Emory University before its commencement.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study design. Questionnaires: Demographics, age, sex, race, ethnicity, education, if employed/actively working, cause of CKD, vascular access yes/no, other comorbidities, medications; Symptoms of Depression (CEDS-20), SF-12, Physical activity self-efficacy questionnaires; CKD Chronic Kidney Disease, PA Physical activity’
Fig. 2
Fig. 2
Integration of Exercise is Medicine framework into Quantextual Smartphone Application

References

    1. Centers for Disease Control and Prevention. Chronic kidney disease surveillance system website. . Accessed 6 Apr 2018.
    1. Powe NR, Melamed ML. Racial disparities in the optimal delivery of chronic kidney disease care. Med Clin N Am. 2005;89(3):475–488. doi: 10.1016/j.mcna.2004.11.004.
    1. Norris K, Nissenson AR. Race, gender, and socioeconomic disparities in CKD in the United States. J Am Soc Nephrol. 2008;19(7):1261–1270. doi: 10.1681/ASN.2008030276.
    1. Xue JL, Ma JZ, Louis TA, Collins AJ. Forecast of the number of patients with end-stage renal disease in the United States to the year 2010. J Am Soc Nephrol. 2001;12(12):2753–2758.
    1. Nigam G, Camacho M, Chang ET, Riaz M. Exploring sleep disorders in patients with chronic kidney disease. Nat Sci Sleep. 2018;10:35–43. doi: 10.2147/NSS.S125839.
    1. Palmer S, Vecchio M, Craig JC, Tonelli M, Johnson DW, Nicolucci A, Pellegrini F, Saglimbene V, Logroscino G, Fishbane S, et al. Prevalence of depression in chronic kidney disease: systematic review and meta-analysis of observational studies. Kidney Int. 2013;84(1):179–191. doi: 10.1038/ki.2013.77.
    1. Abdel-Kader K, Unruh ML, Weisbord SD. Symptom burden, depression, and quality of life in chronic and end-stage kidney disease. Clin J Am Soc Nephrol. 2009;4(6):1057–1064. doi: 10.2215/CJN.00430109.
    1. Isoyama N, Qureshi AR, Avesani CM, Lindholm B, Barany P, Heimburger O, Cederholm T, Stenvinkel P, Carrero JJ. Comparative associations of muscle mass and muscle strength with mortality in dialysis patients. Clin J Am Soc Nephrol. 2014;9(10):1720–1728. doi: 10.2215/CJN.10261013.
    1. Stenvinkel P, Carrero JJ, von Walden F, Ikizler TA, Nader GA. Muscle wasting in end-stage renal disease promulgates premature death: established, emerging and potential novel treatment strategies. Nephrol Dial Transplant. 2016;31(7):1070–1077. doi: 10.1093/ndt/gfv122.
    1. Johansen KL, Chertow GM, Ng AV, Mulligan K, Carey S, Schoenfeld PY, Kent-Braun JA. Physical activity levels in patients on hemodialysis and healthy sedentary controls. Kidney Int. 2000;57(6):2564–2570. doi: 10.1046/j.1523-1755.2000.00116.x.
    1. Johansen KL, Chertow GM, Kutner NG, Dalrymple LS, Grimes BA, Kaysen GA. Low level of self-reported physical activity in ambulatory patients new to dialysis. Kidney Int. 2010;78(11):1164–1170. doi: 10.1038/ki.2010.312.
    1. Stack AG, Molony DA, Rives T, Tyson J, Murthy BV. Association of physical activity with mortality in the US dialysis population. Am J Kidney Dis. 2005;45(4):690–701. doi: 10.1053/j.ajkd.2004.12.013.
    1. O'Hare AM, Tawney K, Bacchetti P, Johansen KL. Decreased survival among sedentary patients undergoing dialysis: results from the dialysis morbidity and mortality study wave 2. Am J Kidney Dis. 2003;41(2):447–454. doi: 10.1053/ajkd.2003.50055.
    1. Kurella Tamura M, Covinsky KE, Chertow GM, Yaffe K, Landefeld CS, McCulloch CE. Functional status of elderly adults before and after initiation of dialysis. N Engl J Med. 2009;361(16):1539–1547. doi: 10.1056/NEJMoa0904655.
    1. Johansen KL, Kaysen GA, Dalrymple LS, Grimes BA, Glidden DV, Anand S, Chertow GM. Association of physical activity with survival among ambulatory patients on dialysis: the comprehensive Dialysis study. Clin J Am Soc Nephrol. 2013;8(2):248–253. doi: 10.2215/CJN.08560812.
    1. Lopes AA, Lantz B, Morgenstern H, Wang M, Bieber BA, Gillespie BW, Li Y, Painter P, Jacobson SH, Rayner HC, et al. Associations of self-reported physical activity types and levels with quality of life, depression symptoms, and mortality in hemodialysis patients: the DOPPS. Clin J Am Soc Nephrol. 2014;9(10):1702–1712. doi: 10.2215/CJN.12371213.
    1. Collins AJ. Cardiovascular mortality in end-stage renal disease. Am J Med Sci. 2003;325(4):163–167. doi: 10.1097/00000441-200304000-00002.
    1. Tonelli M, Wiebe N, Culleton B, House A. Rabbat C, Fok M, McAlister F, Garg AX. Chronic kidney disease and mortality risk: a systematic review. J Am Soc Nephrol. 2006;17(7):2034–2047. doi: 10.1681/ASN.2005101085.
    1. Barcellos FC, Santos IS, Umpierre D, Bohlke M, Hallal PC. Effects of exercise in the whole spectrum of chronic kidney disease: a systematic review. Clin Kidney J. 2015;8(6):753–765. doi: 10.1093/ckj/sfv099.
    1. Johansen KL, Painter PL, Sakkas GK, Gordon P, Doyle J, Shubert T. Effects of resistance exercise training and nandrolone decanoate on body composition and muscle function among patients who receive hemodialysis: a randomized, controlled trial. J Am Soc Nephrol. 2006;17(8):2307–2314. doi: 10.1681/ASN.2006010034.
    1. Painter P, Carlson L, Carey S, Paul SM, Myll J. Physical functioning and health-related quality-of-life changes with exercise training in hemodialysis patients. Am J Kidney Dis. 2000;35(3):482–492. doi: 10.1016/S0272-6386(00)70202-2.
    1. Kouidi E, Grekas D, Deligiannis A, Tourkantonis A. Outcomes of long-term exercise training in dialysis patients: comparison of two training programs. Clin Nephrol. 2004;61(Suppl 1):S31–S38.
    1. Tawney KW, Tawney PJ, Hladik G, Hogan SL, Falk RJ, Weaver C, Moore DT, Lee MY. The life readiness program: a physical rehabilitation program for patients on hemodialysis. Am J Kidney Dis. 2000;36(3):581–591. doi: 10.1053/ajkd.2000.16197.
    1. Cheema B, Abas H, Smith B, O'Sullivan A, Chan M, Patwardhan A, Kelly J, Gillin A, Pang G, Lloyd B, et al. Progressive exercise for anabolism in kidney disease (PEAK): a randomized, controlled trial of resistance training during hemodialysis. J Am Soc Nephrol. 2007;18(5):1594–1601. doi: 10.1681/ASN.2006121329.
    1. Heiwe S, Tollback A, Clyne N. Twelve weeks of exercise training increases muscle function and walking capacity in elderly predialysis patients and healthy subjects. Nephron. 2001;88(1):48–56. doi: 10.1159/000045959.
    1. Viana JL, Kosmadakis GC, Watson EL, Bevington A, Feehally J, Bishop NC, Smith AC. Evidence for anti-inflammatory effects of exercise in CKD. J Am Soc Nephrol. 2014;25(9):2121–2130. doi: 10.1681/ASN.2013070702.
    1. Heiwe S, Jacobson SH. Exercise training for adults with chronic kidney disease. Cochrane Database Syst Rev. 2011;10:CD003236.
    1. Lobelo F, Stoutenberg M, Hutber A. The exercise is medicine Global Health initiative: a 2014 update. Br J Sports Med. 2014;48(22):1627–1633. doi: 10.1136/bjsports-2013-093080.
    1. Lobelo F, Rohm Young D, Sallis R, Garber MD, Billinger SA, Duperly J, Hutber A, Pate RR, Thomas RJ, Widlansky ME, et al. Routine assessment and promotion of physical activity in healthcare settings: a scientific statement from the American Heart Association. Circulation. 2018;137(18):e495–e522. doi: 10.1161/CIR.0000000000000559.
    1. Lobelo F, Kelli HM, Tejedor SC, Pratt M, McConnell MV, Martin SS, Welk GJ. The wild wild west: a framework to integrate mHealth software applications and wearables to support physical activity assessment, counseling and interventions for cardiovascular disease risk reduction. Prog Cardiovasc Dis. 2016;58(6):584–594. doi: 10.1016/j.pcad.2016.02.007.
    1. Stoutenberg M, Galaviz KI, Lobelo F, Joy E, Heath GW, Hutber A, Estabrooks P. A pragmatic application of the RE-AIM framework for evaluating the implementation of physical activity as a standard of care in health systems. Prev Chronic Dis. 2018;15:E54. doi: 10.5888/pcd15.170344.
    1. Bauman AE, Reis RS, Sallis JF, Wells JC, Loos JFR, Martin BW. Correlates of physical activity: why are some people physically active and others not? Lancet. 2012;380:258–271. doi: 10.1016/S0140-6736(12)60735-1.
    1. Haggis C, Sims-Gould J, Winters M, Gutteridge K, McKay HA. Sustained impact of community-based physical activity interventions: key elements for success. BMC Public Health. 2013;13:892. doi: 10.1186/1471-2458-13-892.
    1. Sallis J, Bauman A, Pratt M. Environmental and policy interventions to promote physical activity. Am J Prev Med. 1998;15(4):379–397. doi: 10.1016/S0749-3797(98)00076-2.
    1. Spence JC, Lee RE. Toward a comprehensive model of physical activity. Psychol Sport Exerc. 2003;4(1):7–24. doi: 10.1016/S1469-0292(02)00014-6.
    1. Sallis JF, Glanz K. Physical activity and food environments: solutions to the obesity epidemic. The Milbank Quarterly. 2009;87(1):123–154. doi: 10.1111/j.1468-0009.2009.00550.x.
    1. Patrick K, Pratt M, Sallis RE. The healthcare Sector’s role in the U.S. National Physical Activity Plan. J Phys Act Health. 2009;6(2):S211–S219. doi: 10.1123/jpah.6.s2.s211.
    1. Meyer P, Kayser B, Kossovsky MP, Sigaud P, Carballo D, Keller PF, Martin XE, Farpour-Lambert N, Pichard C, Mach F. Stairs instead of elevators at workplace: cardioprotective effects of a pragmatic intervention. Eur J Cardiovasc Prev Rehabil. 2010;17(5):569–575. doi: 10.1097/HJR.0b013e328338a4dd.
    1. Orrow G, Kinmonth A-L, Sanderson S, Sutton S. Effectiveness of physical activity promotion based in primary care: systematic review and meta-analysis of randomised controlled trials. BMJ (Clinical research ed). 2012;344:–e1389.
    1. Task Force on Community Preventive Services Recommendations to increase physical activity in communities. Am J Prev Med. 2002;22(4S):67–72.
    1. Tulloch H, Fortier M, Hogg W. Physical activity counseling in primary care: who has and who should be counseling? Patient Educ Couns. 2006;64(1–3):6–20. doi: 10.1016/j.pec.2005.10.010.
    1. Gutnick D, Reims K, Davis C, Gainforth H, Jay M, Cole S: Brief Action Planning to Facilitate Behavior Change and Support Patient Self-Management. J Clin Outcomes Manage 2014, 21(1).
    1. Sanders JP, Loveday A, Pearson N, Edwardson C, Yates T, Biddle SJ, Esliger DW. Devices for self-monitoring sedentary time or physical activity: a scoping review. J Med Internet Res. 2016;18(5):e90. doi: 10.2196/jmir.5373.
    1. Exercise is Medicine Credential. . Accessed 6 Sept 2018.
    1. Dixon D, Johnston M. Health behaviours change competency framework: competencies to deliver interventions to change lifestyle behaviours that affect health. In. The Scottish Government: Edinburgh; 2010.
    1. Diabetes Prevention Program Research Group 10-year follow-up of diabetes incidence and weight loss in the diabetes prevention program outcomes study. Lancet. 2009;374(9702):1677–1686. doi: 10.1016/S0140-6736(09)61457-4.
    1. Carleton RN, Thibodeau MA, Teale MJ, Welch PG, Abrams MP, Robinson T, Asmundson GJ. The center for epidemiologic studies depression scale: a review with a theoretical and empirical examination of item content and factor structure. PLoS One. 2013;8(3):e58067. doi: 10.1371/journal.pone.0058067.
    1. Ware J, Jr, Kosinski M, Keller SD. A 12-item short-form health survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996;34(3):220–233. doi: 10.1097/00005650-199603000-00003.
    1. Lacson E, Jr, Xu J, Lin SF, Dean SG, Lazarus JM, Hakim RM. A comparison of SF-36 and SF-12 composite scores and subsequent hospitalization and mortality risks in long-term dialysis patients. Clin J Am Soc Nephrol. 2010;5(2):252–260. doi: 10.2215/CJN.07231009.
    1. McAuley E. Self-efficacy and the maintenance of exercise participation in older adults. J Behav Med. 1993;16(1):103–113. doi: 10.1007/BF00844757.
    1. Laboratories ATSCoPSfCPF ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002;166(1):111–117. doi: 10.1164/ajrccm.166.1.at1102.
    1. Firrell JC, Crain GM. Which setting of the dynamometer provides maximal grip strength? J Hand Surg Am. 1996;21(3):397–401. doi: 10.1016/S0363-5023(96)80351-0.
    1. Haider S, Luger E, Kapan A, Titze S, Lackinger C, Schindler KE, Dorner TE. Associations between daily physical activity, handgrip strength, muscle mass, physical performance and quality of life in prefrail and frail community-dwelling older adults. Qual Life Res. 2016;25(12):3129–3138. doi: 10.1007/s11136-016-1349-8.
    1. Lobelo F, de Quevedo IG. The Evidence in Support of Physicians and Health Care Providers as Physical Activity Role Models. Am J Lifestyle Med. 2016;10:36-52.
    1. Vuori IM, Lavie CJ, Blair SN. Physical activity promotion in the health care system. Mayo Clin Proc. 2013;88(12):1446–1461. doi: 10.1016/j.mayocp.2013.08.020.
    1. Vuori IM, Lavie CJ, Blair SN. Physical Activity Promotion in the Health Care System. Mayo Clin Proc. 2013;88:1446-61.
    1. Lin JS, O’Connor E, Whitlock EP, Beil TL, Zuber SP, Perdue LA, Plaut D, Lutz K. Behavioral Counseling to Promote Physical Activity and a Healthful Diet to Prevent Cardiovascular Disease in Adults: Update of the Evidence for the U.S. Preventive Services Task Force. Evidence Synthesis No. 79. AHRQ Publication No. 11–05149-EF-1. Rockville, MD: Agency for Healthcare Research and Quality; 2010.
    1. Pavey TG, Anokye N, Taylor AH, Trueman P, Moxham T, Fox KR, Hillsdon M, Green C, Campbell JL, Foster C, et al. The clinical effectiveness and cost-effectiveness of exercise referral schemes: a systematic review and economic evaluation. Health technol assess. 2011;15(44):i–xii. doi: 10.3310/hta15440.
    1. Vierron E, Giraudeau B. Sample size calculation for multicenter randomized trial: taking the center effect into account. Contemp Clin Trials. 2007;28(4):451–458. doi: 10.1016/j.cct.2006.11.003.
    1. GM Fitzmaurice, Laird NM, and JH Ware: Applied longitudinal analysis; 2004.
    1. Sedgwick P. Cluster randomised controlled trials: sample size calculations. Bmj. 2013;346(f2839)
    1. Pavey T, Taylor A, Hillsdon M, Fox K, Campbell J, Foster C, Moxham T, Mutrie N, Searle J, Taylor R. Levels and predictors of exercise referral scheme uptake and adherence: a systematic review. J Epidemiol Community Health. 2012;66(8):737–744. doi: 10.1136/jech-2011-200354.
    1. Gallegos-Carrillo K, Garcia-Pena C, Salmeron J, Salgado-de-Snyder VN, Vazquez-Cabrer G, Lobelo F. Exercise-referral scheme to promote physical activity among hypertensive patients: design of a cluster randomized trial in the primary health care units of Mexico's social security system. BMC Public Health. 2014;14:706. doi: 10.1186/1471-2458-14-706.
    1. Verbeke G, Molenberghs G, Thijs H, Lesaffre E, Kenward MG. Sensitivity analysis for nonrandom dropout: a local influence approach. Biometrics. 2001;57(1):7–14. doi: 10.1111/j.0006-341X.2001.00007.x.
    1. Bessa B, de Oliveira LV, Moraes C, Barboza J, Fouque D, Mafra D. Resistance training in hemodialysis patients: a review. Rehabil Nurs. 2015;40(2):111–126. doi: 10.1002/rnj.146.
    1. Konstantinidou E, Koukouvou G, Kouidi E, Deligiannis A, Tourkantonis A. Exercise training in patients with end-stage renal disease on hemodialysis: comparison of three rehabilitation programs. J Rehabil Med. 2002;34(1):40–45. doi: 10.1080/165019702317242695.
    1. Heath G, Kolade V, Haynes JW. Exercise is medicine: a pilot study linking primary care with community physical activity support. Preventive Medicine Reports. 2015; In Press
    1. Gallegos-Carrillo K, Garcia-Pena C, Salmeron J, Salgado-de-Snyder N, Lobelo F. Brief counseling and exercise referral scheme: a pragmatic trial in Mexico. Am J Prev Med. 2017;52(2):249–259. doi: 10.1016/j.amepre.2016.10.021.

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