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

Royal Victoria Hospital, Canada

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Behavioral: Physical activity and exercise education and behaviour counseling from a Registered Kinesiologist and a YMCA Wellness Coach; Behavioral: Unstructured Physical Activity and Exercise Education

Study type: Interventional

Funder types: Other

Identifiers

NCT02093702

AW-100-SD

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

Unstructured Physical Activity and Exercise Education Delivery

Active Comparator group

Description:

50 subjects will receive the standard approach to physical activity and exercise education from a Certified Diabetes Educator.

Treatment:

Behavioral: Unstructured Physical Activity and Exercise Education

Structured Physical Activity and Exercise Education Delivery

Experimental group

Description:

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.

Treatment:

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