Diabetes Exercise and Lifestyle Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Diabetes Exercise and Lifestyle Trial

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High volume combined aerobic/resistance exercise<br> | Behavioral: High volume combined aerobic/resistance exercise<br>* High volume combined aerobic/resistance exercise<br>|
| Active Comparator: Low volume combined aerobic/resistance exercise<br>Low volume combined aerobic/resistance exercise | Behavioral: Low volume combined aerobic/resistance exercise<br>* Low volume combined aerobic/resistance exercise<br>|
| Active Comparator: High volume combined A/R exercise, printouts, pedometers<br>High volume combined aerobic/resistance exercise, printouts, pedometers | Behavioral: High volume combined A/R exercise, printouts, pedometers<br>* High volume combined aerobic/resistance exercise, printouts, pedometers<br>|
| Active Comparator: Low volume combined A/R exercise, printouts, pedometers<br>Low volume combined aerobic/resistance exercise, printouts, pedometers | Behavioral: Low volume combined A/R exercise, printouts, pedometers<br>* Low volume combined aerobic/resistance exercise, printouts, pedometers<br>|
| Active Comparator: Printed PA information, pedometers and step log group<br>Printed physical activity information, pedometers and step log group | Behavioral: Printed PA information, pedometers and step log group<br>* Printed PA information, pedometers and step log group<br>|
| Placebo Comparator: Control<br> | Behavioral: Control<br>* No exercise program provided by the study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome will be A1c at the end of 6 months supervised exercise period. |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, exercise, printed materials