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

Study Overview
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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.

Official Title
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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.

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* 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


Participation Criteria
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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 Has been excluded by the Patient's Physician for any other health-related reason not stated under these exclusion criteria.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Unstructured Physical Activity and Exercise Education Delivery<br>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<br> <br> |
| Experimental: Structured Physical Activity and Exercise Education Delivery<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 12 months | 
| 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. | Baseline and 12 months |