Impact of Structured Physical Activity Education Delivery in Patients With Type 2 Diabetes Mellitus

NCT02093702 | Completed Results

• 1 other identifier: AW-100-SD
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (10)

• Mean Change in Hemoglobin A1c (HbA1c) Levels

  Baseline and 12 months

• Mean Change in Systolic Blood Pressure

  Baseline and 12 months

• Mean Change in Waist Circumference

  Baseline and 12 months

• Mean Change in Body Mass Index

  Baseline and 12 months

• Mean Change in Serum Total Cholesterol

  Baseline and 12 months

• Mean Change in HDL-C

  Baseline and 12 months

• Mean Change in LDL-C

  Baseline and 12 months

• Mean Change in Triglycerides (TGs)

  Baseline and 12 months

• Mean Change in Total Cholesterol: HDL-C Ratio

  Baseline and 12 months

• Mean Change in Diastolic Blood Pressure

  Baseline and 12 months

Secondary Outcomes (2)

• Mean Change in Adherence to the Canadian Diabetes Association's Clinical Practice Guidelines Aerobic Exercise Recommendations

  Baseline and 12 months

• Mean Change in Adherence to the Canadian Diabetes Association's Clinical Practice Guidelines Resistance Exercise Recommendations

  Baseline and 12 months

Study Arms (2)

Unstructured Physical Activity and Exercise Education Delivery

ACTIVE COMPARATOR

50 subjects will receive the standard approach to physical activity and exercise education from a Certified Diabetes Educator.

Behavioral: Unstructured Physical Activity and Exercise Education

Structured Physical Activity and Exercise Education Delivery

EXPERIMENTAL

50 subjects will receive physical activity and exercise education and behaviour counseling from a qualified Exercise Specialist (Registered Kinesiologist). These subjects will receive access to a community health and fitness centre as well as exercise instruction and on-going support and motivation from a YMCA Wellness Coach who focuses on establishing healthy behaviors towards the attainment of personal goals. Subjects will be requested to complete a lifestyle questionnaire at each appointment with their Wellness Coach. Subjects will receive a Physical Activity and Exercise Journal that will help them keep track of their weekly physical activity and exercise activities.

Behavioral: Physical activity and exercise education and behaviour counseling from a Registered Kinesiologist and a YMCA Wellness Coach

Interventions

Physical activity and exercise education and behaviour counseling from a Registered Kinesiologist and a YMCA Wellness Coach BEHAVIORAL

Structured Physical Activity and Exercise Education Delivery

Unstructured Physical Activity and Exercise Education BEHAVIORAL

Unstructured Physical Activity and Exercise Education Delivery

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Victoria Hospital, Canada: lead

Study Sites (1)

Barrie and Community Family Health Team Diabetes Program

Barrie, Ontario, L4M 6L2, Canada

Location

Related Publications (14)

• 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.

  BACKGROUND

• 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.

  PMID: 24070961 BACKGROUND

• 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.

  PMID: 17192512 BACKGROUND

• 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.

  PMID: 27056541 BACKGROUND

• Canadian Institute for Health Information. Pan-Canadian Primary Health Care Indicator Update Report. Canadian Institute for Health Information, 2012. Ottawa, Ontario. 198 pages.

  BACKGROUND

• 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.

  PMID: 21525503 BACKGROUND

• 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.

  PMID: 21540423 BACKGROUND

• 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.

  PMID: 16888470 BACKGROUND

• McManus RM, Stitt LW, Bargh GJM. Population survey of diabetes knowledge and protective behaviours. Can J Diabetes. 2006;30:256-263.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 14597589 BACKGROUND

• 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.

  PMID: 19495557 BACKGROUND

• 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.

  PMID: 12421890 BACKGROUND

• 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.

  PMID: 12610001 BACKGROUND

Related Links

• YMCA Wellness Coaching

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr. Andrew Wozniak
• Organization: Barrie and Community Family Health Team

andrew.wozniak@barriefht.ca

(705) 728-2618

Study Officials

• Dr. Andrew Wozniak, MD, CCFP

  Barrie and Community Family Health Team

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, CCFP

Study Record Dates

• First Submitted: March 3, 2014
• First Posted: March 21, 2014
• Study Start: April 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: June 1, 2016
• Last Updated: October 6, 2016
• Results First Posted: October 6, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)