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Exercise and Nerve Function in Diabetes

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
University of Kansas
ClinicalTrials.gov Identifier:
NCT00970060
First received: September 1, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted

September 1, 2009
September 1, 2009
June 2008
October 2009   (final data collection date for primary outcome measure)
  • Quantitative sensory testing [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
  • Nerve conduction studies [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
  • Proprioception [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
  • Dermal and epidermal nerve fiber densities [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Clinical assessments of neuropathy, pain, body mass index, muscle strength, and glycemic control (glycosylated hemoglobin or A1C) [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Exercise and Nerve Function in Diabetes
Effectiveness of an Exercise Program on Nerve Function and Cutaneous Nerve Fibers in Adults With Type 2 Diabetes

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.

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.
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Diabetic Neuropathy
Behavioral: Exercise
Supervised moderately-intense exercise, including both aerobic and strengthening activities. Sessions are 3-4 days per week for 10 weeks.
Experimental: Exercise program
Supervised moderately-intense exercise, including both aerobic and strengthening activities. Sessions are 3-4 days per week for 10 weeks.
Intervention: Behavioral: Exercise
Kluding PM, Pasnoor M, Singh R, Jernigan S, Farmer K, Rucker J, Sharma NK, Wright DE. The effect of exercise on neuropathic symptoms, nerve function, and cutaneous innervation in people with diabetic peripheral neuropathy. J Diabetes Complications. 2012 Sep-Oct;26(5):424-9. doi: 10.1016/j.jdiacomp.2012.05.007. Epub 2012 Jun 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
30
October 2009
October 2009   (final data collection date for primary outcome measure)

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
Both
40 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00970060
11385, GCRC #105
No
Patricia Kluding PhD, University of Kansas Medical Center
University of Kansas
Not Provided
Principal Investigator: Patricia Kluding, PhD University of Kansas
University of Kansas
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP