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

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: NCT02093702
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-03
• Study First Submitted QC: 2014-03-20
• Study First Posted: 2014-03-21
• Study Start: 2014-04
• Primary Completion: 2015-09
• Study Completion: 2016-06
• Results First Submitted: 2016-06-10
• Status Verified: 2016-08
• Results First Submitted QC: 2016-08-15
• Last Update Submitted: 2016-08-15
• Results First Posted: 2016-10-06
• Last Update Posted: 2016-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Total Cholesterol: HDL-C Ratio	Baseline and 12 months
Mean Change in Triglycerides (TGs)	Baseline and 12 months
Mean Change in Diastolic Blood Pressure	Baseline and 12 months

Secondary Outcome Measures

Name	Time	Method
Mean Change in Adherence to the Canadian Diabetes Association's Clinical Practice Guidelines Resistance Exercise Recommendations	Baseline and 12 months	The Canadian Diabetes Association's Clinical Practice Guidelines recommends at least 2 sessions per week of resistance exercise.
Mean Change in Adherence to the Canadian Diabetes Association's Clinical Practice Guidelines Aerobic Exercise Recommendations	Baseline and 12 months	The Canadian Diabetes Association's Clinical Practice Guidelines recommends at least 150 minutes per week of aerobic exercise.

Trial Locations

Locations (1)

Barrie and Community Family Health Team Diabetes Program; 🇨🇦 Barrie, Ontario, Canada