Diabetes Exercise and Lifestyle Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-12-31

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).

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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.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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High volume combined aerobic/resistance exercise

Group Type ACTIVE_COMPARATOR

High volume combined aerobic/resistance exercise

Intervention Type BEHAVIORAL

High volume combined aerobic/resistance exercise

Low volume combined aerobic/resistance exercise

Group Type ACTIVE_COMPARATOR

Low volume combined aerobic/resistance exercise

Intervention Type BEHAVIORAL

Low volume combined aerobic/resistance exercise

High volume combined A/R exercise, printouts, pedometers

High volume combined aerobic/resistance exercise, printouts, pedometers

Group Type ACTIVE_COMPARATOR

High volume combined A/R exercise, printouts, pedometers

Intervention Type BEHAVIORAL

High volume combined aerobic/resistance exercise, printouts, pedometers

Low volume combined A/R exercise, printouts, pedometers

Low volume combined aerobic/resistance exercise, printouts, pedometers

Group Type ACTIVE_COMPARATOR

Low volume combined A/R exercise, printouts, pedometers

Intervention Type BEHAVIORAL

Low volume combined aerobic/resistance exercise, printouts, pedometers

Printed PA information, pedometers and step log group

Printed physical activity information, pedometers and step log group

Group Type ACTIVE_COMPARATOR

Printed PA information, pedometers and step log group

Intervention Type BEHAVIORAL

Printed PA information, pedometers and step log group

Control

Group Type PLACEBO_COMPARATOR

Control

Intervention Type BEHAVIORAL

No exercise program provided by the study

Interventions

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High volume combined aerobic/resistance exercise

Intervention Type BEHAVIORAL

Low volume combined aerobic/resistance exercise

Intervention Type BEHAVIORAL

High volume combined A/R exercise, printouts, pedometers

High volume combined aerobic/resistance exercise, printouts, pedometers

Intervention Type BEHAVIORAL

Low volume combined A/R exercise, printouts, pedometers

Low volume combined aerobic/resistance exercise, printouts, pedometers

Intervention Type BEHAVIORAL

Printed PA information, pedometers and step log group

Intervention Type BEHAVIORAL

Control

No exercise program provided by the study

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes