Overview

This trial is active, not recruiting.

Condition diabetes mellitus
Treatments high volume combined aerobic/resistance exercise, low volume combined aerobic/resistance exercise, high volume combined a/r exercise, printouts, pedometers, low volume combined a/r exercise, printouts, pedometers, printed pa information, pedometers and step log group, control
Phase phase 0
Sponsor University of Calgary
Start date February 2010
End date December 2012
Trial size 26 participants
Trial identifier NCT00877864, CHREB 22251, DEAL- 22251

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model factorial assignment
Masking single blind (caregiver)
Primary purpose treatment
Arm
(Active Comparator)
high volume combined aerobic/resistance exercise
High volume combined aerobic/resistance exercise
(Active Comparator)
Low volume combined aerobic/resistance exercise
low volume combined aerobic/resistance exercise
Low volume combined aerobic/resistance exercise
(Active Comparator)
High volume combined aerobic/resistance exercise, printouts, pedometers
high volume combined a/r exercise, printouts, pedometers
High volume combined aerobic/resistance exercise, printouts, pedometers
(Active Comparator)
Low volume combined aerobic/resistance exercise, printouts, pedometers
low volume combined a/r exercise, printouts, pedometers
Low volume combined aerobic/resistance exercise, printouts, pedometers
(Active Comparator)
Printed physical activity information, pedometers and step log group
printed pa information, pedometers and step log group
Printed PA information, pedometers and step log group
(Placebo Comparator)
control
No exercise program provided by the study

Primary Outcomes

Measure
The primary outcome will be A1c at the end of 6 months supervised exercise period.
time frame: 6 months

Eligibility Criteria

Male or female participants from 35 years up to 75 years old.

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

Additional Information

Official title Diabetes Exercise and Lifestyle Trial
Principal investigator Ron Sigal, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2011.
Information provided to ClinicalTrials.gov by University of Calgary.