N/A
Completed N=5
Impact of Structured Physical Activity Education Delivery in Patients With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT02093702 ↗Enrolled (actual)
5
Serious AEs
—
Results posted
Oct 2016
Primary outcomePrimary: Mean Change in Hemoglobin A1c (HbA1c) Levels — 0.001; -0.007 mmol/mol
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Hemoglobin A1c (HbA1c) Levels |
0.001; -0.007 | — |
| PRIMARY Mean Change in Systolic Blood Pressure |
5.0; 7 | — |
| PRIMARY Mean Change in Waist Circumference |
0.7; -3.4 | — |
| PRIMARY Mean Change in Body Mass Index |
0.6; -2.0 | — |
| PRIMARY Mean Change in Serum Total Cholesterol |
-0.75; -0.13 | — |
| PRIMARY Mean Change in HDL-C |
-0.03; 0.08 | — |
| PRIMARY Mean Change in LDL-C |
-0.59; 0.08 | — |
| PRIMARY Mean Change in Triglycerides (TGs) |
-0.28; -0.63 | — |
| PRIMARY Mean Change in Total Cholesterol: HDL-C Ratio |
-0.7; -0.4 | — |
| PRIMARY Mean Change in Diastolic Blood Pressure |
5; 2 | — |
| SECONDARY Mean Change in Adherence to the Canadian Diabetes Association's Clinical Practice Guidelines Aerobic Exercise Recommendations |
58; 26 | — |
| SECONDARY Mean Change in Adherence to the Canadian Diabetes Association's Clinical Practice Guidelines Resistance Exercise Recommendations |
0; 0.7 | — |
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
- Pregnant
- Has been excluded by the Patient's Physician for any other health-related reason not stated under these exclusion criteria.
Data sourced from ClinicalTrials.gov (NCT02093702). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.