Diabetes Exercise and Lifestyle Trial

Early Phase 1

• Conditions: Diabetes Mellitus
• Interventions: Behavioral: High volume combined aerobic/resistance exercise; Behavioral: Low volume combined aerobic/resistance exercise; Behavioral: High volume combined A/R exercise, printouts, pedometers; Behavioral: Low volume combined A/R exercise, printouts, pedometers; Behavioral: Printed PA information, pedometers and step log group; Behavioral: Control

• Registration Number: NCT00877864
• Lead Sponsor: University of Calgary

Brief Summary

The objective of this study is to determine the effects of supervised combined aerobic and resistance training, and the effects of stage-matched written materials delivered by mail or internet, alone or in combination, on glycemic control as reflected in A1C (glycated hemoglobin).

Detailed Description

Background Rationale: Structured, supervised exercise programs involving aerobic exercise, resistance exercise or their combination resulted in significant improvements in glycemic control in type 2 diabetes. It has also been shown that programs which include a psychological/behavioral component in addition to diet and exercise have been most effective for long-term treatment of obesity in diabetes. The supervised exercise program has stronger evidence for improvement of metabolic control and cardiac risk, but its longer-term sustainability has not been demonstrated, and it is relatively costly. A stage-matched printed materials/pedometer intervention has been shown to increase physical activity over a longer period of time, and likely at a lower per-patient cost than the supervised exercise intervention, but with less evidence for improvement of metabolic control.

Study Timeline

• Study First Submitted: 2009-04-06
• Study First Submitted QC: 2009-04-07
• Study First Posted: 2009-04-08
• Study Start: 2010-02
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-04
• Last Update Posted: 2011-08-05
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• type 2 diabetes
• A1c 0.700-0.099
• ability to read and write English
• signed ICF

Exclusion Criteria

• participation in previous 6 months in exercise > 2 times per week for at least 20 min per session
• insulin therapy changes in medication for diabetes, BP or Lipids

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
High volume combined aerobic/resistance exercise	High volume combined aerobic/resistance exercise	-
Low volume combined aerobic/resistance exercise	Low volume combined aerobic/resistance exercise	Low volume combined aerobic/resistance exercise
High volume combined A/R exercise, printouts, pedometers	High volume combined A/R exercise, printouts, pedometers	High volume combined aerobic/resistance exercise, printouts, pedometers
Low volume combined A/R exercise, printouts, pedometers	Low volume combined A/R exercise, printouts, pedometers	Low volume combined aerobic/resistance exercise, printouts, pedometers
Printed PA information, pedometers and step log group	Printed PA information, pedometers and step log group	Printed physical activity information, pedometers and step log group
Control	Control	-

Primary Outcome Measures

Name	Time	Method
The primary outcome will be A1c at the end of 6 months supervised exercise period.	6 months

Trial Locations

Locations (1)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada