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Exercise and Nerve Function in Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00970060
First Posted: September 2, 2009
Last Update Posted: July 4, 2013
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.
Information provided by (Responsible Party):
Patricia Kluding, PhD, University of Kansas Medical Center Research Institute
  Purpose
The purpose of this study is to describe the effect of a 10-week exercise program on nerve function and number of nerve fibers in the skin in the lower leg in people with diabetic neuropathy.

Condition Intervention
Diabetic Neuropathy Behavioral: Exercise

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Effectiveness of an Exercise Program on Nerve Function and Cutaneous Nerve Fibers in Adults With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Patricia Kluding, PhD, University of Kansas Medical Center Research Institute:

Primary Outcome Measures:
  • Quantitative sensory testing [ Time Frame: 10 weeks ]
  • Nerve conduction studies [ Time Frame: 10 weeks ]
  • Proprioception [ Time Frame: 10 weeks ]
  • Dermal and epidermal nerve fiber densities [ Time Frame: 10 weeks ]

Secondary Outcome Measures:
  • Clinical assessments of neuropathy, pain, body mass index, muscle strength, and glycemic control (glycosylated hemoglobin or A1C) [ Time Frame: 10 weeks ]

Enrollment: 26
Study Start Date: June 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise program
Supervised moderately-intense exercise, including both aerobic and strengthening activities. Sessions are 3-4 days per week for 10 weeks.
Behavioral: Exercise
Supervised moderately-intense exercise, including both aerobic and strengthening activities. Sessions are 3-4 days per week for 10 weeks.

Detailed Description:
The objective for this application is to quantify the benefits of exercise on nerve function including proprioception, and investigate the relationship of these findings with improvements in epidermal and dermal innervation. In this pilot project, we will pursue 2 specific aims: 1) determine the effect of an exercise intervention on nerve function in people with diabetic neuropathy, and 2) assess changes in cutaneous innervation following participation in an exercise program.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 40-70
  • Type 2 diabetes
  • Peripheral neuropathy

Exclusion Criteria:

  • Serious cardiac history or other medical problems that would prevent safe participation in exercise
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00970060


Locations
United States, Kansas
Patricia Kluding PhD
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Patricia Kluding, PhD
Investigators
Principal Investigator: Patricia Kluding, PhD University of Kansas Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Patricia Kluding, PhD, Associate Professor, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00970060     History of Changes
Other Study ID Numbers: 11385
GCRC #105 ( Other Identifier: Clinical and Translational Science Unit )
First Submitted: September 1, 2009
First Posted: September 2, 2009
Last Update Posted: July 4, 2013
Last Verified: July 2013

Keywords provided by Patricia Kluding, PhD, University of Kansas Medical Center Research Institute:
neuropathy
diabetes

Additional relevant MeSH terms:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases