Resistance Exercise in Already-Active Diabetic Individuals (READI): Study rationale, design and methods for a randomized controlled trial of resistance and aerobic exercise in type 1 diabetes

Contemporary Clinical Trials - Tập 41 - Trang 129-138 - 2015
Jane E. Yardley1,2,3, Glen P. Kenny3,4, Bruce A. Perkins5, Michael C. Riddell6, Gary S. Goldfield7, Lois Donovan8,9, Stasia Hadjiyannakis7, George A. Wells4,10, Penny Phillips4, Ronald J. Sigal8,9
1University of Alberta, Augustana Campus, Camrose, AB T4V 2R3, Canada
2Manitoba Institute of Child Health, University of Manitoba, Winnipeg, MB R3E 3P4, Canada
3School of Human Kinetics, University of Ottawa, Ottawa, ON K1N 6N5, Canada
4Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON K1H 8L6, Canada
5Mount Sinai Hospital and Lunenfeld Tanenbaum Research Institute, University of Toronto, Toronto, ON M5G 2M9, Canada
6School of Kinesiology and Health Science, York University, Toronto, ON M3J 1P3, Canada
7Healthy Active Living & Obesity Research Group, Children's Hospital of Eastern Ontario Research Institute, Ottawa, ON K1H 8L1, Canada
8Department of Medicine, Cardiac Sciences, Cumming School of Medicine, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB T2T 5C7, Canada
9Department of Community Health Sciences, Cumming School of Medicine, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB T2T 5C7, Canada
10Cardiovascular Research Methods Centre, University of Ottawa Heart Institute, Ottawa, ON K1Y 4W7, Canada

Tài liệu tham khảo

Warram, 1997, Epidemiology of non-insulin-dependent diabetes mellitus and its macrovascular complications. A basis for the development of cost-effective programs, Endocrinol Metab Clin North Am, 26, 165, 10.1016/S0889-8529(05)70239-5 Krolewski, 1996, Epidemiology of late diabetic complications. A basis for the development and evaluation of preventive programs, Endocrinol Metab Clin North Am, 25, 217, 10.1016/S0889-8529(05)70322-4 Stratton, 2000, Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study, BMJ, 321, 405, 10.1136/bmj.321.7258.405 Boulé, 2001, Effects of exercise on glycemic control and body mass in type 2 diabetes mellitus: a meta-analysis of controlled clinical trials, JAMA, 286, 1218, 10.1001/jama.286.10.1218 Boulé, 2003, Meta-analysis of the effect of structured exercise training on cardiorespiratory fitness in type 2 diabetes mellitus, Diabetologia, 46, 1071, 10.1007/s00125-003-1160-2 Tonoli, 2012, Effects of different types of acute and chronic (training) exercise on glycaemic control in type 1 diabetes mellitus: a meta-analysis, Sports Med, 42, 1059, 10.1007/BF03262312 Kennedy, 2013, Does exercise improve glycaemic control in type 1 diabetes? A systematic review and meta-analysis, PLoS One, 8, e58861, 10.1371/journal.pone.0058861 Wallberg, 1992, Exercise and diabetes mellitus, Exerc Sport Sci Rev, 20, 339 Stratton, 1987, Improved glycemic control after supervised 8-wk exercise program in insulin-dependent diabetic adolescents, Diabetes Care, 10, 589, 10.2337/diacare.10.5.589 Lehmann, 1997, Impact of physical activity on cardiovascular risk factors in IDDM, Diabetes Care, 20, 1603, 10.2337/diacare.20.10.1603 Landt, 1985, Effects of exercise training on insulin sensitivity in adolescents with type I diabetes, Diabetes Care, 8, 461, 10.2337/diacare.8.5.461 Wallberg-Henriksson, 1982, Increased peripheral insulin sensitivity and muscle mitochondrial enzymes but unchanged blood glucose control in type I diabetics after physical training, Diabetes, 31, 1044, 10.2337/diacare.31.12.1044 Waden, 2005, Leisure time physical activity is associated with poor glycemic control in type 1 diabetic women: the FinnDiane study, Diabetes Care, 28, 777, 10.2337/diacare.28.4.777 Yardley, 2013, Resistance versus aerobic exercise: acute effects on glycemia in type 1 diabetes, Diabetes Care, 36, 537, 10.2337/dc12-0963 Durak, 1990, Randomized crossover study of effect of resistance training on glycemic control, muscular strength, and cholesterol in type I diabetic men, Diabetes Care, 13, 1039, 10.2337/diacare.13.10.1039 Mosher, 1998, Aerobic circuit exercise training: effect on adolescents with well-controlled insulin-dependent diabetes mellitus, Arch Phys Med Rehabil, 79, 652, 10.1016/S0003-9993(98)90039-9 Ramalho, 2006, The effect of resistance versus aerobic training on metabolic control in patients with type-1 diabetes mellitus, Diabetes Res Clin Pract, 72, 271, 10.1016/j.diabres.2005.11.011 Canadian Diabetes Association Clinical Practice Guidelines Expert Committee, 2013, Canadian Diabetes Association clinical practice guidelines, Can J Diabetes, 37, S1 Schulz, 2010, CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials, Ann Intern Med, 152, 726, 10.7326/0003-4819-152-11-201006010-00232 Bode, 2000, Clinical utility of the continuous glucose monitoring system, Diabetes Technol Ther, 2, S35, 10.1089/15209150050214104 Canadian Diabetes Association Clinical Guidelines Expert Commmittee, 2008, Canadian Diabetes Association clinical practice guidelines for the prevention and management of diabetes in Canada, Can J Diabetes, 32, 1 Jeppsson, 1996, Capillary blood on filter paper for determination of HbA1c by ion exchange chromatography, Diabetes Care, 19, 142, 10.2337/diacare.19.2.142 Egier, 2011, Measurement of hemoglobin A1c from filter papers for population-based studies, Clin Chem, 57, 577, 10.1373/clinchem.2010.156380 Heymsfield, 1998, Evaluation of total and regional body composition, 41 Lemieux, 1996, Seven-year changes in body fat and visceral adipose tissue in women. Association with indexes of plasma glucose-insulin homeostasis, Diabetes Care, 19, 983, 10.2337/diacare.19.9.983 Goodpaster, 1997, Subcutaneous abdominal fat and thigh muscle composition predict insulin sensitivity independently of visceral fat, Diabetes, 46, 1579, 10.2337/diacare.46.10.1579 Nelson, 1996, Analysis of body–composition techniques and models for detecting change in soft tissue with strength training, Am J Clin Nutr, 63, 678, 10.1093/ajcn/63.5.678 Canadian Society for Exercise Physiology (CSEP), 2003 Friedewald, 1972, Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge, Clin Chem, 18, 499, 10.1093/clinchem/18.6.499 Ware, 1994 Bott, 1998, Validation of a diabetes-specific quality-of-life scale for patients with type 1 diabetes, Diabetes Care, 21, 757, 10.2337/diacare.21.5.757 EuroQol Group, 1996 Jacobson, 1994, The evaluation of two measures of quality of life in patients with type I and type II diabetes, Diabetes Care, 17, 267, 10.2337/diacare.17.4.267 Van Agt, 1994, Test–retest reliability of health state evaluations collected with EuroQol questionnaire, Soc Sci Med, 39, 1537, 10.1016/0277-9536(94)90005-1 Elvik, 1995, The validity of using health state indexes in measuring the consequences of traffic injury for public health, Soc Sci Med, 40, 1385, 10.1016/0277-9536(94)00264-T Brazier, 1993, Testing the validity of the EuroQol and comparing it with the SF-36 health survey questionnaire, Qual Life Res, 2, 169, 10.1007/BF00435221 DCCT Research Group, 1993, The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus, N Engl J Med, 329, 977, 10.1056/NEJM199309303291401 DCCT Research Group, 1995, Effect of intensive diabetes management on macrovascular events and risk factors in the Diabetes Control and Complications Trial, Am J Cardiol, 75, 894, 10.1016/S0002-9149(99)80683-3 Lawson, 1999, Effect of intensive therapy on early macrovascular disease in young individuals with type 1 diabetes. A systematic review and meta-analysis, Diabetes Care, 22, B35