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Exercise and Activity Guidance in Older Adults With Diabetes

This study has been completed.
Sponsor:
Collaborator:
Department of Veterans Affairs
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00344240
First received: June 23, 2006
Last updated: February 2, 2010
Last verified: April 2007
History of Changes
  Purpose

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 Intervention
Type 2 Diabetes
 Behavioral: Functional circuit training with lifestyle behavior

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Aerobic Performance,Mobility Limitations and Exercise in Older Adults With Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Functional mobility performance
  • Physical activity

Estimated Enrollment: 240
Study Start Date: August 2005
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00344240

Locations
United States, Michigan
Mobility Research Center
Ann Arbor, Michigan, United States, 48105
Sponsors and Collaborators
University of Michigan
Department of Veterans Affairs
Investigators
Principal Investigator: Caroline S Blaum, MD University of Michigan. Ann Arbor Veterans Affairs Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00344240     History of Changes
Other Study ID Numbers: 2004-0966
Study First Received: June 23, 2006
Last Updated: February 2, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
type 2 diabetes
exercise
activity guidance
health education

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Mobility Limitation
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013