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

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ClinicalTrials.gov Identifier: NCT02093702
Recruitment Status : Completed
First Posted : March 21, 2014
Results First Posted : October 6, 2016
Last Update Posted : October 6, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Andrew Wozniak, Royal Victoria Hospital, Canada

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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Behavioral: Physical activity and exercise education and behaviour counseling from a Registered Kinesiologist and a YMCA Wellness Coach Behavioral: Unstructured Physical Activity and Exercise Education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Behavioral: Unstructured Physical Activity and Exercise Education
Experimental: 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.
Behavioral: Physical activity and exercise education and behaviour counseling from a Registered Kinesiologist and a YMCA Wellness Coach



Primary Outcome Measures :
  1. Mean Change in Hemoglobin A1c (HbA1c) Levels [ Time Frame: Baseline and 12 months ]
  2. Mean Change in Systolic Blood Pressure [ Time Frame: Baseline and 12 months ]
  3. Mean Change in Waist Circumference [ Time Frame: Baseline and 12 months ]
  4. Mean Change in Body Mass Index [ Time Frame: Baseline and 12 months ]
  5. Mean Change in Serum Total Cholesterol [ Time Frame: Baseline and 12 months ]
  6. Mean Change in HDL-C [ Time Frame: Baseline and 12 months ]
  7. Mean Change in LDL-C [ Time Frame: Baseline and 12 months ]
  8. Mean Change in Triglycerides (TGs) [ Time Frame: Baseline and 12 months ]
  9. Mean Change in Total Cholesterol: HDL-C Ratio [ Time Frame: Baseline and 12 months ]
  10. Mean Change in Diastolic Blood Pressure [ Time Frame: Baseline and 12 months ]

Secondary Outcome Measures :
  1. Mean Change in Adherence to the Canadian Diabetes Association's Clinical Practice Guidelines Aerobic Exercise Recommendations [ Time Frame: Baseline and 12 months ]
    The Canadian Diabetes Association's Clinical Practice Guidelines recommends at least 150 minutes per week of aerobic exercise.

  2. Mean Change in Adherence to the Canadian Diabetes Association's Clinical Practice Guidelines Resistance Exercise Recommendations [ Time Frame: Baseline and 12 months ]
    The Canadian Diabetes Association's Clinical Practice Guidelines recommends at least 2 sessions per week of resistance exercise.



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02093702


Locations
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Canada, Ontario
Barrie and Community Family Health Team Diabetes Program
Barrie, Ontario, Canada, L4M 6L2
Sponsors and Collaborators
Royal Victoria Hospital, Canada
Investigators
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Principal Investigator: Dr. Andrew Wozniak, MD, CCFP Barrie and Community Family Health Team

Publications:
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.
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.
Canadian Institute for Health Information. Pan-Canadian Primary Health Care Indicator Update Report. Canadian Institute for Health Information, 2012. Ottawa, Ontario. 198 pages.
McManus RM, Stitt LW, Bargh GJM. Population survey of diabetes knowledge and protective behaviours. Can J Diabetes. 2006;30:256-263.
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.

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Responsible Party: Dr. Andrew Wozniak, MD, CCFP, Royal Victoria Hospital, Canada
ClinicalTrials.gov Identifier: NCT02093702     History of Changes
Other Study ID Numbers: AW-100-SD
First Posted: March 21, 2014    Key Record Dates
Results First Posted: October 6, 2016
Last Update Posted: October 6, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases