Type 2 Diabetes Mellitus Clinical Trial
Official title:
Impact of Structured Physical Activity Education Delivery on Hemoglobin A1c (HbA1c) Levels, Blood Pressure, Lipid Profile, Body Mass Index (BMI), Waist Circumference, and Adherence to Clinical Practice Guidelines Weekly Physical Activity Recommendations in Patients With Type 2 Diabetes Mellitus
The objective of this study is to assess whether a structured exercise program compared to
routine recommendation for exercise has any positive impact on disease outcome in patients
with type 2 diabetes.
This study aims to assess whether a structured exercise program has an impact on the
following determinants of the disease in type 2 diabetes: HbA1C, blood pressure, lipids,
body mass index and waist circumference. It also aims to assess the compliance and retention
of patients with type 2 diabetes in a structured exercise program.
| Status | Active, not recruiting |
| Enrollment | 40 |
| Est. completion date | |
| Est. primary completion date | July 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 64 Years |
| Eligibility |
Inclusion Criteria: - Man or woman with type 2 diabetes - Ready to begin regular physical activity - Age equal to or greater than 18 - Age equal to or less than 64. Exclusion Criteria: - Any vascular disease - Exhibits symptoms of coronary artery disease (CAD) - History of losing balance because of dizziness - History of losing consciousness - Has a bone or joint problem that could be made worse by a change in physical activity - Pregnant - Has been excluded by the Patient's Physician for any other health-related reason not stated under these exclusion criteria. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Barrie and Community Family Health Team Diabetes Program | Barrie | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| Royal Victoria Hospital, Canada |
Canada,
Buse JB, Ginsberg HN, Bakris GL, Clark NG, Costa F, Eckel R, Fonseca V, Gerstein HC, Grundy S, Nesto RW, Pignone MP, Plutzky J, Porte D, Redberg R, Stitzel KF, Stone NJ; American Heart Association; American Diabetes Association. Primary prevention of cardiovascular diseases in people with diabetes mellitus: a scientific statement from the American Heart Association and the American Diabetes Association. Circulation. 2007 Jan 2;115(1):114-26. Epub 2006 Dec 27. — View Citation
Canadian Institute for Health Information. Pan-Canadian Primary Health Care Indicator Update Report. Canadian Institute for Health Information, 2012. Ottawa, Ontario. 198 pages.
Chudyk A, Petrella RJ. Effects of exercise on cardiovascular risk factors in type 2 diabetes: a meta-analysis. Diabetes Care. 2011 May;34(5):1228-37. doi: 10.2337/dc10-1881. Review. — View Citation
Duncan GE, Perri MG, Theriaque DW, Hutson AD, Eckel RH, Stacpoole PW. Exercise training, without weight loss, increases insulin sensitivity and postheparin plasma lipase activity in previously sedentary adults. Diabetes Care. 2003 Mar;26(3):557-62. — View Citation
Gornall A, Lévesque L, Sigal RJ. A Pilot Study of Physical Activity Education Delivery in Diabetes Education Centres in Ontario. Can J Diabetes. 2008; 32(2):123-130.
J.R. Fowles, C. Shields, R.J.L. Murphy and P Dunbar. Developing Competency in Diabetes Education Volume 3: Physical Activity and Exercise Professional Resource Manual. The Canadian Diabetes Association. 2012. Toronto, Ontario. 110 pages.
Kraus WE, Houmard JA, Duscha BD, Knetzger KJ, Wharton MB, McCartney JS, Bales CW, Henes S, Samsa GP, Otvos JD, Kulkarni KR, Slentz CA. Effects of the amount and intensity of exercise on plasma lipoproteins. N Engl J Med. 2002 Nov 7;347(19):1483-92. — View Citation
Majumdar SR, Johnson JA, Bowker SL, Booth GL, et al. A Canadian consensus for the standardized evaluation of quality improvement interventions in type 2 diabetes. Can J Diabetes. 2005 2005;29:220-229.
McManus RM, Stitt LW, Bargh GJM. Population survey of diabetes knowledge and protective behaviours. Can J Diabetes. 2006;30:256-263.
McSweeney JC, Cody M, O'Sullivan P, Elberson K, Moser DK, Garvin BJ. Women's early warning symptoms of acute myocardial infarction. Circulation. 2003 Nov 25;108(21):2619-23. Epub 2003 Nov 3. — View Citation
Plotnikoff RC, Taylor LM, Wilson PM, Courneya KS, Sigal RJ, Birkett N, Raine K, Svenson LW. Factors associated with physical activity in Canadian adults with diabetes. Med Sci Sports Exerc. 2006 Aug;38(8):1526-34. — View Citation
Sigal RJ, Armstrong MJ, Colby P, et al. Canadian Diabetes Association 2013 Clinical Practice Guidelines for the Prevention and Management of Diabetes in Canada: Physical Activity and Diabetes. Can J Diabetes 2013; 37(suppl 1): S40-S44.
Umpierre D, Ribeiro PA, Kramer CK, Leitão CB, Zucatti AT, Azevedo MJ, Gross JL, Ribeiro JP, Schaan BD. Physical activity advice only or structured exercise training and association with HbA1c levels in type 2 diabetes: a systematic review and meta-analysis. JAMA. 2011 May 4;305(17):1790-9. doi: 10.1001/jama.2011.576. Review. — View Citation
Zanuso S, Jimenez A, Pugliese G, Corigliano G, Balducci S. Exercise for the management of type 2 diabetes: a review of the evidence. Acta Diabetol. 2010 Mar;47(1):15-22. doi: 10.1007/s00592-009-0126-3. Epub 2009 Jun 3. Review. — View Citation
* Note: There are 14 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in Hemoglobin A1c (HbA1c) levels | Month 0 (baseline values), Month 4, Month 8, Month 12 (1 year) | No | |
| Primary | Change in blood pressure | Month 0 (baseline values), Month 4, Month 8, Month 12 (1 year) | No | |
| Primary | Change in waist circumference | Month 0 (baseline values), Month 4, Month 8, Month 12 (1 year) | No | |
| Primary | Change in body mass index | Month 0 (baseline values), Month 4, Month 8, Month 12 (1 year) | No | |
| Primary | Change in serum total cholesterol | Month 0 (baseline values), Month 4, Month 8, Month 12 (1 year) | No | |
| Primary | Change in HDL-C | Month 0 (baseline values), Month 4, Month 8, Month 12 (1 year) | No | |
| Primary | Change in LDL-C | Month 0 (baseline values), Month 4, Month 8, Month 12 (1 year) | No | |
| Primary | Change in triglycerides (TGs) | Month 0 (baseline values), Month 4, Month 8, Month 12 (1 year) | No | |
| Primary | Change in total cholesterol: HDL-C ratio | Month 0 (baseline values), Month 4, Month 8, Month 12 (1 year) | No | |
| Secondary | Change in adherence to weekly physical activity recommendations | Adherence to weekly physical activity recommendations will be determined using the information reported by each client in their Physical Activity and Exercise Log. This data will be collected on month 12 (1 year). | Month 0 (baseline values), Month 4, Month 8, Month 12 (1 year) | No |
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