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Clinical Trials/NCT02093702
NCT02093702
Completed
N/A

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.

Royal Victoria Hospital, Canada1 site in 1 country5 target enrollmentApril 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Type 2 Diabetes Mellitus
Sponsor
Royal Victoria Hospital, Canada
Enrollment
5
Locations
1
Primary Endpoint
Mean Change in Hemoglobin A1c (HbA1c) Levels
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2014
End Date
June 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Royal Victoria Hospital, Canada
Responsible Party
Principal Investigator
Principal Investigator

Dr. Andrew Wozniak

MD, CCFP

Royal Victoria Hospital, Canada

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

Outcomes

Primary Outcomes

Mean Change in Hemoglobin A1c (HbA1c) Levels

Time Frame: Baseline and 12 months

Mean Change in LDL-C

Time Frame: Baseline and 12 months

Mean Change in Systolic Blood Pressure

Time Frame: Baseline and 12 months

Mean Change in Waist Circumference

Time Frame: Baseline and 12 months

Mean Change in Body Mass Index

Time Frame: Baseline and 12 months

Mean Change in Serum Total Cholesterol

Time Frame: Baseline and 12 months

Mean Change in HDL-C

Time Frame: Baseline and 12 months

Mean Change in Total Cholesterol: HDL-C Ratio

Time Frame: Baseline and 12 months

Mean Change in Triglycerides (TGs)

Time Frame: Baseline and 12 months

Mean Change in Diastolic Blood Pressure

Time Frame: Baseline and 12 months

Secondary Outcomes

  • Mean Change in Adherence to the Canadian Diabetes Association's Clinical Practice Guidelines Resistance Exercise Recommendations(Baseline and 12 months)
  • Mean Change in Adherence to the Canadian Diabetes Association's Clinical Practice Guidelines Aerobic Exercise Recommendations(Baseline and 12 months)

Study Sites (1)

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