Clinical trial NCT02093702: Impact of Structured Physical Activity Education Delivery in Patients With Type 2 Diabetes Mellitus
Official title: Impact of Structured Physical Activity Education Delivery on Hemoglobin A1c Levels, Blood Pressure, Lipid Profile, Body Mass Index, Waist Circumference, and Adherence to Canadian Diabetes Association Clinical Practice Guidelines Weekly Physical Activity Recommendations for Patients With Type 2 Diabetes Mellitus: A Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Royal Victoria Hospital, Canada
Sponsor class: OTHER
First posted: 2014-03-21
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean Change in Hemoglobin A1c (HbA1c) Levels
timeFrame: Baseline and 12 months
measure: Mean Change in Systolic Blood Pressure
timeFrame: Baseline and 12 months
measure: Mean Change in Waist Circumference
timeFrame: Baseline and 12 months
measure: Mean Change in Body Mass Index
timeFrame: Baseline and 12 months
measure: Mean Change in Serum Total Cholesterol
timeFrame: Baseline and 12 months
measure: Mean Change in HDL-C
timeFrame: Baseline and 12 months
measure: Mean Change in LDL-C
timeFrame: Baseline and 12 months
measure: Mean Change in Triglycerides (TGs)
timeFrame: Baseline and 12 months
measure: Mean Change in Total Cholesterol: HDL-C Ratio
timeFrame: Baseline and 12 months
measure: Mean Change in Diastolic Blood Pressure
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Mean Change in Adherence to the Canadian Diabetes Association's Clinical Practice Guidelines Aerobic Exercise Recommendations
timeFrame: Baseline and 12 months
measure: Mean Change in Adherence to the Canadian Diabetes Association's Clinical Practice Guidelines Resistance Exercise Recommendations
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Barrie
country: Canada
facility: Barrie and Community Family Health Team Diabetes Program
state: Ontario
Study officials:
affiliation: Barrie and Community Family Health Team
name: Dr. Andrew Wozniak, MD, CCFP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Canadian Diabetes Association Clinical Practice Guidelines Expert Committee; Booth G, Cheng AY. Canadian Diabetes Association 2013 clinical practice guidelines for the prevention and management of diabetes in Canada. Methods. Can J Diabetes. 2013 Apr;37 Suppl 1:S4-7. doi: 10.1016/j.jcjd.2013.01.010. Epub 2013 Mar 26. No abstract available.
citation: 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. doi: 10.1161/CIRCULATIONAHA.106.179294. Epub 2006 Dec 27.
citation: Gornall A, Levesque L, Sigal RJ. A Pilot Study of Physical Activity Education Delivery in Diabetes Education Centres in Ontario. Can J Diabetes. 2008;32(2):123-30. doi: 10.1016/S1499-2671(08)22009-5. Epub 2012 Dec 10.
citation: Canadian Institute for Health Information. Pan-Canadian Primary Health Care Indicator Update Report. Canadian Institute for Health Information, 2012. Ottawa, Ontario. 198 pages.
citation: 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.
citation: Umpierre D, Ribeiro PA, Kramer CK, Leitao 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.
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. doi: 10.1249/01.mss.0000228937.86539.95.
citation: McManus RM, Stitt LW, Bargh GJM. Population survey of diabetes knowledge and protective behaviours. Can J Diabetes. 2006;30:256-263.
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.
citation: 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. doi: 10.1161/01.CIR.0000097116.29625.7C. Epub 2003 Nov 3.
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.
citation: 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. doi: 10.1056/NEJMoa020194.
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. doi: 10.2337/diacare.26.3.557.