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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Physical activity and exercise education and behaviour counseling from a Registered Kinesiologist and a YMCA Wellness Coach
Unstructured Physical Activity and Exercise Education
Sponsored by
Royal Victoria Hospital, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Barrie and Community Family Health Team Diabetes Program

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Unstructured Physical Activity and Exercise Education Delivery

Structured Physical Activity and Exercise Education Delivery

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Mean Change in Hemoglobin A1c (HbA1c) Levels
Mean Change in Systolic Blood Pressure
Mean Change in Waist Circumference
Mean Change in Body Mass Index
Mean Change in Serum Total Cholesterol
Mean Change in HDL-C
Mean Change in LDL-C
Mean Change in Triglycerides (TGs)
Mean Change in Total Cholesterol: HDL-C Ratio
Mean Change in Diastolic Blood Pressure

Secondary Outcome Measures

Mean Change in Adherence to the Canadian Diabetes Association's Clinical Practice Guidelines Aerobic Exercise Recommendations
The Canadian Diabetes Association's Clinical Practice Guidelines recommends at least 150 minutes per week of aerobic exercise.
Mean Change in Adherence to the Canadian Diabetes Association's Clinical Practice Guidelines Resistance Exercise Recommendations
The Canadian Diabetes Association's Clinical Practice Guidelines recommends at least 2 sessions per week of resistance exercise.

Full Information

First Posted
March 3, 2014
Last Updated
August 15, 2016
Sponsor
Royal Victoria Hospital, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT02093702
Brief Title
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

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Royal Victoria Hospital, Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Unstructured Physical Activity and Exercise Education Delivery
Arm Type
Active Comparator
Arm Description
50 subjects will receive the standard approach to physical activity and exercise education from a Certified Diabetes Educator.
Arm Title
Structured Physical Activity and Exercise Education Delivery
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physical activity and exercise education and behaviour counseling from a Registered Kinesiologist and a YMCA Wellness Coach
Intervention Type
Behavioral
Intervention Name(s)
Unstructured Physical Activity and Exercise Education
Primary Outcome Measure Information:
Title
Mean Change in Hemoglobin A1c (HbA1c) Levels
Time Frame
Baseline and 12 months
Title
Mean Change in Systolic Blood Pressure
Time Frame
Baseline and 12 months
Title
Mean Change in Waist Circumference
Time Frame
Baseline and 12 months
Title
Mean Change in Body Mass Index
Time Frame
Baseline and 12 months
Title
Mean Change in Serum Total Cholesterol
Time Frame
Baseline and 12 months
Title
Mean Change in HDL-C
Time Frame
Baseline and 12 months
Title
Mean Change in LDL-C
Time Frame
Baseline and 12 months
Title
Mean Change in Triglycerides (TGs)
Time Frame
Baseline and 12 months
Title
Mean Change in Total Cholesterol: HDL-C Ratio
Time Frame
Baseline and 12 months
Title
Mean Change in Diastolic Blood Pressure
Time Frame
Baseline and 12 months
Secondary Outcome Measure Information:
Title
Mean Change in Adherence to the Canadian Diabetes Association's Clinical Practice Guidelines Aerobic Exercise Recommendations
Description
The Canadian Diabetes Association's Clinical Practice Guidelines recommends at least 150 minutes per week of aerobic exercise.
Time Frame
Baseline and 12 months
Title
Mean Change in Adherence to the Canadian Diabetes Association's Clinical Practice Guidelines Resistance Exercise Recommendations
Description
The Canadian Diabetes Association's Clinical Practice Guidelines recommends at least 2 sessions per week of resistance exercise.
Time Frame
Baseline and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Andrew Wozniak, MD, CCFP
Organizational Affiliation
Barrie and Community Family Health Team
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barrie and Community Family Health Team Diabetes Program
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6L2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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.
Results Reference
background
PubMed Identifier
24070961
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.
Results Reference
background
PubMed Identifier
17192512
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.
Results Reference
background
PubMed Identifier
27056541
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.
Results Reference
background
Citation
Canadian Institute for Health Information. Pan-Canadian Primary Health Care Indicator Update Report. Canadian Institute for Health Information, 2012. Ottawa, Ontario. 198 pages.
Results Reference
background
PubMed Identifier
21525503
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.
Results Reference
background
PubMed Identifier
21540423
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.
Results Reference
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PubMed Identifier
16888470
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.
Results Reference
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Citation
McManus RM, Stitt LW, Bargh GJM. Population survey of diabetes knowledge and protective behaviours. Can J Diabetes. 2006;30:256-263.
Results Reference
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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.
Results Reference
background
PubMed Identifier
14597589
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.
Results Reference
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PubMed Identifier
19495557
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.
Results Reference
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PubMed Identifier
12421890
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.
Results Reference
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PubMed Identifier
12610001
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.
Results Reference
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Impact of Structured Physical Activity Education Delivery in Patients With Type 2 Diabetes Mellitus

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