Diabetes Exercise and Lifestyle Trial
This trial is active, not recruiting.
|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|
|Sponsor||University of Calgary|
|Start date||February 2010|
|End date||December 2012|
|Trial size||26 participants|
|Trial identifier||NCT00877864, CHREB 22251, DEAL- 22251|
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).
|Endpoint classification||safety/efficacy study|
|Intervention model||factorial assignment|
|Masking||single blind (caregiver)|
The primary outcome will be A1c at the end of 6 months supervised exercise period.
time frame: 6 months
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
|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.|
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