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Exercise and Activity Guidance in Older Adults With Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00344240
Recruitment Status : Completed
First Posted : June 26, 2006
Last Update Posted : February 3, 2010
US Department of Veterans Affairs
Information provided by:
University of Michigan

Brief Summary:
The purpose of the project is to better understand how exercise and education will help mobility and health in older adults with diabetes. The investigators are trying to learn what type of exercises and classes are needed to help older adults stay active. This knowledge will eventually prove useful in helping patients and doctors understand what is needed to keep older adults with Type 2 diabetes as healthy as possible.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: Functional circuit training with lifestyle behavior Not Applicable

Detailed Description:
  1. Information and health screening: Interested persons are screened for eligibility and undergo a directed medical history and examination, echocardiogram (if not done within one year), limited ABI test, and maximal treadmill test with oxygen kinetics.
  2. Measure fitness level at the beginning of the exercise training, at 10 and 20 weeks: DEXA scan, body fat analysis, strength and balance measurements, and blood tests.
  3. Train for 10 weeks in a supervised small group format. Classes meet three times a week for an hour. Participants are randomly assigned to:

1) Flexibility and toning exercises + health education, or 2) Functional circuit training + home activities + tailored physical activity guidance.

4. Follow-up phone calls for an additional 10 weeks.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aerobic Performance,Mobility Limitations and Exercise in Older Adults With Diabetes
Study Start Date : August 2005
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Functional mobility performance
  2. Physical activity

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • History of type 2 diabetes on medications
  • Age 60 or older
  • Able to attend local class 3 times per week for 10 weeks

Exclusion Criteria:

  • Ejection fraction <40%
  • Symptomatic obstructive valvular disease (primarily aortic stenosis)
  • Atrial fibrillation with poor rate control (particularly during exercise), or high grade AV block
  • Substantial dementia (Folstein Mini Mental State Examination <24 out of 30)
  • Blood tests suggesting severe renal (Cr>3.0) or hepatic (transaminases>4x normal) disease
  • Alcohol intake >3 oz/day
  • Hemiplegia or lower limb amputation
  • Participating in regular exercise 2 or more hours per week.
  • Significant orthopedic or musculoskeletal condition that limits weight bearing
  • Acute medical conditions, such as acute flare-up of joint condition or infection
  • Normal FBS in those with equivocal diabetes history (< 130)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00344240

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United States, Michigan
Mobility Research Center
Ann Arbor, Michigan, United States, 48105
Sponsors and Collaborators
University of Michigan
US Department of Veterans Affairs
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Principal Investigator: Caroline S Blaum, MD University of Michigan. Ann Arbor Veterans Affairs Hospital
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00344240    
Other Study ID Numbers: 2004-0966
First Posted: June 26, 2006    Key Record Dates
Last Update Posted: February 3, 2010
Last Verified: April 2007
Keywords provided by University of Michigan:
type 2 diabetes
activity guidance
health education
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases