Step Monitoring to improve ARTERial health (SMARTER) through step count prescription in type 2 diabetes and hypertension: trial design and methods

Kaberi Dasgupta, Ellen Rosenberg, Stella S Daskalopoulou, SMARTER collaborators, Kaberi Dasgupta, Ellen Rosenberg, Stella S Daskalopoulou, SMARTER collaborators

Abstract

Background: With increasing numbers of type 2 diabetes (DM2) and hypertension patients, there is a pressing need for effective, time-efficient and sustainable strategies to help physicians support their patients to achieve higher physical activity levels. SMARTER will determine whether physician-delivered step count prescriptions reduce arterial stiffness over a one-year period, compared with usual care, in sedentary overweight/obese adults with DM2/hypertension.

Design: Randomized, allocation-concealed, assessor-blind, multisite clinical trial. The primary outcome is change in arterial stiffness over one year. The secondary outcomes include changes in physical activity, individual vascular risk factors, medication use, and anthropometric parameters. Assessments are at baseline and one year.

Methods: Participants are sedentary/low active adults with 25 ≤ BMI < 40 kg/m2 followed for DM2/hypertension by a collaborating physician. The active arm uses pedometers to track daily step counts and review logs with their physicians at 3 to 4-month intervals. A written step count prescription is provided at each visit, aiming to increase counts by ≥3,000 steps/day over one year, with an individualized rate increase. The control arm visits physicians at the same frequency and receives advice to engage in physical activity 30-60 minutes/day. SMARTER will enroll 364 individuals to detect a 10 ± 5% difference in arterial stiffness change between arms. Arterial stiffness is assessed noninvasively with carotid femoral pulse wave velocity using applanation tonometry.

Discussion: The importance of SMARTER lies not simply in the use of pedometer-based monitoring but also on its integration into a prescription-based intervention delivered by the treating physician. Equally important is the measurement of impact of this approach on a summative indicator of arterial health, arterial stiffness. If effectiveness is demonstrated, this strategy has strong potential for widespread uptake and implementation, given that it is well-aligned with the structure of current clinical practice.

Trial registration: ClinicalTrials.gov (NCT01475201).

Figures

Figure 1
Figure 1
Step count prescription framework by baseline activity category. Months in red are those at which a clinic visit occurs. All participants should ultimately achieve a net increase of at least 3,000 steps/day from baseline, as indicated in light blue.

References

    1. Gregg EW, Gerzoff RB, Caspersen CJ, Williamson DF, Narayan KM. Relationship of walking to mortality among US adults with diabetes. Arch Intern Med. 2003;163:1440–1447. doi: 10.1001/archinte.163.12.1440.
    1. Hu FB, Stampfer MJ, Solomon C, Liu S, Colditz GA, Speizer FE. et al.Physical activity and risk for cardiovascular events in diabetic women. Ann Intern Med. 2001;134:96–105. doi: 10.7326/0003-4819-134-2-200101160-00009.
    1. Hill JO, Wyatt HR, Reed GW, Peters JC. Obesity and the environment: where do we go from here? Science. 2003;299:853–855. doi: 10.1126/science.1079857.
    1. Sturm R. Stemming the global obesity epidemic: what can we learn from data about social and economic trends? Public Health. 2008;122:739–746. doi: 10.1016/j.puhe.2008.01.004.
    1. Booth GL, Kapral MK, Fung K, Tu JV. Relation between age and cardiovascular disease in men and women with diabetes compared with non-diabetic people: a population-based retrospective cohort study. Lancet. 2006;368:29–36. doi: 10.1016/S0140-6736(06)68967-8.
    1. Lee WL, Cheung AM, Cape D, Zinman B. Impact of diabetes on coronary artery disease in women and men: a meta-analysis of prospective studies. Diabetes Care. 2000;23:962–968. doi: 10.2337/diacare.23.7.962.
    1. Haffner SM, Lehto S, Ronnemaa T, Pyorala K, Laakso M. Mortality from coronary heart disease in subjects with type 2 diabetes and in nondiabetic subjects with and without prior myocardial infarction. N Engl J Med. 1998;339:229–234. doi: 10.1056/NEJM199807233390404.
    1. Orrow G, Kinmonth AL, Sanderson S, Sutton S. Effectiveness of physical activity promotion based in primary care: systematic review and meta-analysis of randomised controlled trials. BMJ. 2012;344:e1389. doi: 10.1136/bmj.e1389.
    1. Elley CR, Kerse N, Arroll B, Robinson E. Effectiveness of counselling patients on physical activity in general practice: cluster randomised controlled trial. BMJ. 2003;326:793. doi: 10.1136/bmj.326.7393.793.
    1. Grandes G, Sanchez A, Sanchez-Pinilla RO, Torcal J, Montoya I, Lizarraga K. et al.Effectiveness of physical activity advice and prescription by physicians in routine primary care: a cluster randomized trial. Arch Intern Med. 2009;169:694–701. doi: 10.1001/archinternmed.2009.23.
    1. Katz MH. Writing more specific exercise prescriptions. Arch Intern Med. 2012;172:1283–1284. doi: 10.1001/archinternmed.2012.3196.
    1. Yates T, Haffner SM, Schulte PJ, Thomas L, Huffman KM, Bales CW, Association between change in daily ambulatory activity and cardiovascular events in people with impaired glucose tolerance (NAVIGATOR trial): a cohort analysis. The Lancet. 2013. [Epub ahead of print]
    1. Bravata DM, Smith-Spangler C, Sundaram V, Gienger AL, Lin N, Lewis R. et al.Using pedometers to increase physical activity and improve health: a systematic review. JAMA. 2007;298:2296–2304. doi: 10.1001/jama.298.19.2296.
    1. Casey D, De CM, Dasgupta K. Understanding physical activity facilitators and barriers during and following a supervised exercise programme in type 2 diabetes: a qualitative study. Diabet Med. 2010;27:79–84. doi: 10.1111/j.1464-5491.2009.02873.x.
    1. Delamater AM. Improving patient adherence. Clinical Diabetes. 2006;24:71–77. doi: 10.2337/diaclin.24.2.71.
    1. Kolt GS, Schofield GM, Kerse N, Garrett N, Ashton T, Patel A. Healthy steps trial: pedometer-based advice and physical activity for low-active older adults. Ann Fam Med. 2012;10:206–212. doi: 10.1370/afm.1345.
    1. Blackstock OJ, Addison DN, Brennan JS, Alao OA. Trust in primary care providers and antiretroviral adherence in an urban HIV clinic. J Health Care Poor Underserved. 2012;23:88–98.
    1. Bell RA, Arcury TA, Ip E, Grzywacz JG, Nguyen H, Kirk JK. et al.Correlates of physician trust among rural older adults with diabetes. Am J Health Behav. 2013;37:660–666. doi: 10.5993/AJHB.37.5.10.
    1. De GK, Deforche B, Tudor-Locke C, De B I. Increasing physical activity in Belgian type 2 diabetes patients: a three-arm randomized controlled trial. Int J Behav Med. 2011;18:188–198. doi: 10.1007/s12529-010-9124-7.
    1. Mancia G, De BG, Dominiczak A, Cifkova R, Fagard R, Germano G. et al.Guidelines for the Management of Arterial Hypertension: The Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC) J Hypertens. 2007;2007(25):1105–1187.
    1. Willum-Hansen T, Staessen JA, Torp-Pedersen C, Rasmussen S, Thijs L, Ibsen H. et al.Prognostic value of aortic pulse wave velocity as index of arterial stiffness in the general population. Circulation. 2006;113:664–670. doi: 10.1161/CIRCULATIONAHA.105.579342.
    1. Mattace-Raso FU, van der Cammen TJ, Hofman A, van Popele NM, Bos ML, Schalekamp MA. et al.Arterial stiffness and risk of coronary heart disease and stroke: the Rotterdam Study. Circulation. 2006;113:657–663. doi: 10.1161/CIRCULATIONAHA.105.555235.
    1. Mitchell GF, Hwang SJ, Vasan RS, Larson MG, Pencina MJ, Hamburg NM. et al.Arterial stiffness and cardiovascular events: the Framingham Heart Study. Circulation. 2010;121:505–511. doi: 10.1161/CIRCULATIONAHA.109.886655.
    1. Kaess BM, Rong J, Larson MG, Hamburg NM, Vita JA, Levy D. et al.Aortic stiffness, blood pressure progression, and incident hypertension. JAMA. 2012;308:875–881. doi: 10.1001/2012.jama.10503.
    1. Madden KM, Lockhart C, Cuff D, Potter TF, Meneilly GS. Short-term aerobic exercise reduces arterial stiffness in older adults with type 2 diabetes, hypertension, and hypercholesterolemia. Diabetes Care. 2009;32:1531–1535. doi: 10.2337/dc09-0149.
    1. Aoyagi Y, Park H, Kakiyama T, Park S, Yoshiuchi K, Shephard RJ. Yearlong physical activity and regional stiffness of arteries in older adults: the Nakanojo Study. Eur J Appl Physiol. 2010;109:455–464. doi: 10.1007/s00421-010-1357-2.
    1. Jennersjo P, Ludvigsson J, Lanne T, Nystrom FH, Ernerudh J, Ostgren CJ. Pedometer-determined physical activity is linked to low systemic inflammation and low arterial stiffness in type 2 diabetes. Diabet Med. 2012;29:1119–1125. doi: 10.1111/j.1464-5491.2012.03621.x.
    1. Cyarto EV, Myers AM, Tudor-Locke C. Pedometer accuracy in nursing home and community-dwelling older adults. Med Sci Sports Exerc. 2004;36:205–209. doi: 10.1249/01.MSS.0000113476.62469.98.
    1. Hackam DG, Khan NA, Hemmelgarn BR, Rabkin SW, Touyz RM, Campbell NR. et al.The 2010 Canadian Hypertension Education Program recommendations for the management of hypertension: part 2 - therapy. Can J Cardiol. 2010;2010(26):249–258.
    1. Tudor-Locke C, Bassett DR Jr. How many steps/day are enough? Preliminary pedometer indices for public health. Sports Med. 2004;34:1–8. doi: 10.2165/00007256-200434010-00001.
    1. Chen CH, Nevo E, Fetics B, Pak PH, Yin FC, Maughan WL. et al.Estimation of central aortic pressure waveform by mathematical transformation of radial tonometry pressure. Validation of generalized transfer function. Circulation. 1997;95:1827–1836. doi: 10.1161/01.CIR.95.7.1827.
    1. Pauca AL, O'Rourke MF, Kon ND. Prospective evaluation of a method for estimating ascending aortic pressure from the radial artery pressure waveform. Hypertension. 2001;38:932–937. doi: 10.1161/hy1001.096106.
    1. Sharman JE, Lim R, Qasem AM, Coombes JS, Burgess MI, Franco J. et al.Validation of a generalized transfer function to noninvasively derive central blood pressure during exercise. Hypertension. 2006;47:1203–1208. doi: 10.1161/01.HYP.0000223013.60612.72.
    1. O'Rourke M, Jiang XJ. Use of radial artery applanation tonometry. J Am Coll Cardiol. 1999;34:951–952.
    1. O'Rourke MF, Pauca A, Jiang XJ. Pulse wave analysis. Br J Clin Pharmacol. 2001;51:507–522. doi: 10.1046/j.0306-5251.2001.01400.x.
    1. Mahmud A, Feely J. Acute effect of caffeine on arterial stiffness and aortic pressure waveform. Hypertension. 2001;38:227–231. doi: 10.1161/01.HYP.38.2.227.
    1. Manjoo P, Joseph L, Pilote L, Dasgupta K. Sex differences in step count-blood pressure association: a preliminary study in type 2 diabetes. PLoS One. 2010;5:e14086. doi: 10.1371/journal.pone.0014086. doi:10.1371/journal.pone.0014086.
    1. Manjoo P, Joseph L, Dasgupta K. Abdominal adiposity and daily step counts as determinants of glycemic control in cohort of patients with type 2 diabetes mellitus. Nutrition and Diabetes. 2012;2:e25. doi: 10.1038/nutd.2011.22.
    1. Dasgupta K, Chan C, Da Costa D, Pilote L, De Civita M, Ross N. et al.Walking behaviour and glycemic control in type 2 diabetes: seasonal and gender differences--study design and methods. Cardiovasc Diabetol. 2007;6:1. doi: 10.1186/1475-2840-6-1.
    1. Quinn RR, Hemmelgarn BR, Padwal RS, Myers MG, Cloutier L, Bolli P. et al.The 2010 Canadian Hypertension Education Program recommendations for the management of hypertension: part I - blood pressure measurement, diagnosis and assessment of risk. Can J Cardiol. 2010;2010(26):241–248.
    1. Tran DV, Hofer TL, Lee T, Cembrowski GS. Unique approach to derivation of random error in laboratory assays: application to glycohemoglobin testing demonstrates poor clinical performance for immunochemistry assay. Diabetes Technol Ther. 2003;5:975–978. doi: 10.1089/152091503322641015.
    1. Albareda M, Rodriguez-Espinosa J, Murugo M, de LA, Corcoy R. Assessment of insulin sensitivity and beta-cell function from measurements in the fasting state and during an oral glucose tolerance test. Diabetologia. 2000;43:1507–1511. doi: 10.1007/s001250051561.
    1. Bonora E, Formentini G, Calcaterra F, Lombardi S, Marini F, Zenari L. et al.HOMA-estimated insulin resistance is an independent predictor of cardiovascular disease in type 2 diabetic subjects: prospective data from the Verona Diabetes Complications Study. Diabetes Care. 2002;25:1135–1141. doi: 10.2337/diacare.25.7.1135.
    1. Chang AM, Smith MJ, Bloem CJ, Galecki AT, Halter JB, Supiano MA. Limitation of the homeostasis model assessment to predict insulin resistance and beta-cell dysfunction in older people. J Clin Endocrinol Metab. 2006;91:629–634. doi: 10.1210/jc.2005-1803.
    1. Chen J, Wildman RP, Hamm LL, Muntner P, Reynolds K, Whelton PK. et al.Association between inflammation and insulin resistance in U.S. nondiabetic adults: results from the Third National Health and Nutrition Examination Survey. Diabetes Care. 2004;27:2960–2965. doi: 10.2337/diacare.27.12.2960.
    1. Dixon JB, Dixon AF, O'Brien PE. Improvements in insulin sensitivity and beta-cell function (HOMA) with weight loss in the severely obese. Homeostatic model assessment. Diabet Med. 2003;20:127–134. doi: 10.1046/j.1464-5491.2003.00889.x.
    1. Miyatake N, Nishikawa H, Morishita A, Kunitomi M, Wada J, Suzuki H. et al.Daily walking reduces visceral adipose tissue areas and improves insulin resistance in Japanese obese subjects. Diabetes Res Clin Pract. 2002;58:101–107. doi: 10.1016/S0168-8227(02)00129-8.
    1. World Health Organization (WHO) GSoDPAaH. Facts Related to Chronic Dieases. 2003. .
    1. Marshall SJ, Levy SS, Tudor-Locke CE, Kolkhorst FW, Wooten KM, Ji M. et al.Translating physical activity recommendations into a pedometer-based step goal: 3000 steps in 30 minutes. Am J Prev Med. 2009;36:410–415. doi: 10.1016/j.amepre.2009.01.021.
    1. Dasgupta K, Joseph L, Pilote L, Strachan I, Sigal RJ, Chan C. Daily steps are low year-round and dip lower in fall/winter: findings from a longitudinal diabetes cohort. Cardiovasc Diabetol. 2010;9:81. doi: 10.1186/1475-2840-9-81.
    1. Dasgupta K, Grover SA, Da Costa D, Lowensteyn I, Yale JF, Rahme E. Impact of modified glucose target and exercise interventions on vascular risk factors. Diabetes Res Clin Pract. 2006;72:53–60. doi: 10.1016/j.diabres.2005.09.010.
    1. Colley RC, Garriguet D, Janssen I, Craig CL, Clarke J, Tremblay MS. Physical activity of Canadian adults: accelerometer results from the 2007 to 2009 Canadian Health Measures Survey. Health Rep. 2009;2011(22):7–14.
    1. Vlachopoulos C, Aznaouridis K, Stefanadis C. Prediction of cardiovascular events and all-cause mortality with arterial stiffness: a systematic review and meta-analysis. J Am Coll Cardiol. 2010;55:1318–1327. doi: 10.1016/j.jacc.2009.10.061.

Source: PubMed

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

3
Abonner