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

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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02093702

Enrollment

Registered

2014-03-21

Start date

2014-04-30

Completion date

2016-06-30

Last updated

2016-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

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.

Interventions

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

BEHAVIORALUnstructured Physical Activity and Exercise Education

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

Canada

Participant flow

Participants by arm

Arm	Count
Standard PA Education for People With T2DM (From a CDE) Subjects in the control arm (n = 2) received the standard approach to PA education from a Canadian Certified Diabetes Educator (CDE).	2
Structured PA Education Program for People With T2DM Subjects in the experimental arm (n = 3) participated in a structured PA education program for people with T2DM.	3
Total	5

Baseline characteristics

Characteristic	Standard PA Education for People With T2DM (From a CDE)	Structured PA Education Program for People With T2DM	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	2 Participants	3 Participants	5 Participants
Sex: Female, Male Female	1 Participants	2 Participants	3 Participants
Sex: Female, Male Male	1 Participants	1 Participants	2 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 0	0 / 0
serious Total, serious adverse events	0 / 0	0 / 0