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

NCT ID: NCT02093702

Last Updated: 2016-10-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Unstructured Physical Activity and Exercise Education Delivery

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

Group Type ACTIVE_COMPARATOR

Unstructured Physical Activity and Exercise Education

Intervention Type BEHAVIORAL

Structured Physical Activity and Exercise Education Delivery

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.

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

Interventions

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

Intervention Type BEHAVIORAL

Unstructured Physical Activity and Exercise Education

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royal Victoria Hospital, Canada

OTHER

Sponsor Role lead

Responsible Party

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Dr. Andrew Wozniak

MD, CCFP

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dr. Andrew Wozniak, MD, CCFP

Role: PRINCIPAL_INVESTIGATOR

Barrie and Community Family Health Team

Locations

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Barrie and Community Family Health Team Diabetes Program

Barrie, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 24070961 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17192512 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27056541 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 21525503 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21540423 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16888470 (View on PubMed)

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

Reference Type 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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 14597589 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19495557 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12421890 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12610001 (View on PubMed)

Other Identifiers

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AW-100-SD

Identifier Type: -

Identifier Source: org_study_id

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