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

August 15, 2016 updated by: Dr. Andrew Wozniak, Royal Victoria Hospital, Canada

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Barrie, Ontario, Canada, L4M 6L2
        • Barrie and Community Family Health Team Diabetes Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean Change in Hemoglobin A1c (HbA1c) Levels
Time Frame: Baseline and 12 months
Baseline and 12 months
Mean Change in Systolic Blood Pressure
Time Frame: Baseline and 12 months
Baseline and 12 months
Mean Change in Waist Circumference
Time Frame: Baseline and 12 months
Baseline and 12 months
Mean Change in Body Mass Index
Time Frame: Baseline and 12 months
Baseline and 12 months
Mean Change in Serum Total Cholesterol
Time Frame: Baseline and 12 months
Baseline and 12 months
Mean Change in HDL-C
Time Frame: Baseline and 12 months
Baseline and 12 months
Mean Change in LDL-C
Time Frame: Baseline and 12 months
Baseline and 12 months
Mean Change in Triglycerides (TGs)
Time Frame: Baseline and 12 months
Baseline and 12 months
Mean Change in Total Cholesterol: HDL-C Ratio
Time Frame: Baseline and 12 months
Baseline and 12 months
Mean Change in Diastolic Blood Pressure
Time Frame: Baseline and 12 months
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
Time Frame: Baseline and 12 months
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
Time Frame: Baseline and 12 months
The Canadian Diabetes Association's Clinical Practice Guidelines recommends at least 2 sessions per week of resistance exercise.
Baseline and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Victoria Hospital, Canada

Investigators

  • Principal Investigator: Dr. Andrew Wozniak, MD, CCFP, Barrie and Community Family Health Team

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

March 3, 2014

First Submitted That Met QC Criteria

March 20, 2014

First Posted (Estimate)

March 21, 2014

Study Record Updates

Last Update Posted (Estimate)

October 6, 2016

Last Update Submitted That Met QC Criteria

August 15, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AW-100-SD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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