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Completed

NCT Number: NCT00344240

Exercise and Activity Guidance in Older Adults With Diabetes

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.

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Key information

About this study

  • 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.
  • 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.
  • Train for 10 weeks in a supervised small group format. Classes meet three times a week for an hour. Participants are randomly assigned to:
  • Flexibility and toning exercises + health education, or 2) Functional circuit training + home activities + tailored physical activity guidance.
  • Follow-up phone calls for an additional 10 weeks.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Functional circuit training with lifestyle behavior

Behavioral

Primary outcomes

  1. Functional mobility performance

  2. Physical activity

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • US Department of Veterans Affairs

Registry information

Official study title

Aerobic Performance,Mobility Limitations and Exercise in Older Adults With Diabetes

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Jun 26, 2006
Registry last updated
Feb 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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