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Completed

NCT Number: NCT02093702

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barrie and Community Family Health Team Diabetes Program

Barrie, Ontario, L4M 6L2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physical activity and exercise education and behaviour counseling from a Registered Kinesiologist and a YMCA Wellness Coach

Behavioral

Unstructured Physical Activity and Exercise Education

Behavioral

Primary outcomes

  1. Mean Change in Hemoglobin A1c (HbA1c) Levels

    Time frame: Baseline and 12 months

  2. Mean Change in Systolic Blood Pressure

    Time frame: Baseline and 12 months

  3. Mean Change in Waist Circumference

    Time frame: Baseline and 12 months

  4. Mean Change in Body Mass Index

    Time frame: Baseline and 12 months

  5. Mean Change in Serum Total Cholesterol

    Time frame: Baseline and 12 months

  6. Mean Change in HDL-C

    Time frame: Baseline and 12 months

  7. Mean Change in LDL-C

    Time frame: Baseline and 12 months

  8. Mean Change in Triglycerides (TGs)

    Time frame: Baseline and 12 months

  9. Mean Change in Total Cholesterol: HDL-C Ratio

    Time frame: Baseline and 12 months

  10. Mean Change in Diastolic Blood Pressure

    Time frame: Baseline and 12 months

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Royal Victoria Hospital, Canada

Other

Registry information

Official study title

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.

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Mar 21, 2014
Registry last updated
Oct 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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