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Exercise and Nerve Function in Diabetes

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ClinicalTrials.gov Identifier: NCT00970060
Recruitment Status : Completed
First Posted : September 2, 2009
Last Update Posted : July 4, 2013
Sponsor:
Information provided by (Responsible Party):
Patricia Kluding, PhD, University of Kansas Medical Center

Tracking Information
First Submitted Date  ICMJE September 1, 2009
First Posted Date  ICMJE September 2, 2009
Last Update Posted Date July 4, 2013
Study Start Date  ICMJE June 2008
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2009)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2009)
Clinical assessments of neuropathy, pain, body mass index, muscle strength, and glycemic control (glycosylated hemoglobin or A1C) [ Time Frame: 10 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exercise and Nerve Function in Diabetes
Official Title  ICMJE Effectiveness of an Exercise Program on Nerve Function and Cutaneous Nerve Fibers in Adults With Type 2 Diabetes
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Diabetic Neuropathy
Intervention  ICMJE Behavioral: Exercise
Supervised moderately-intense exercise, including both aerobic and strengthening activities. Sessions are 3-4 days per week for 10 weeks.
Study Arms  ICMJE 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 3, 2013)
26
Original Estimated Enrollment  ICMJE
 (submitted: September 1, 2009)
30
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00970060
Other Study ID Numbers  ICMJE 11385
GCRC #105 ( Other Identifier: Clinical and Translational Science Unit )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Patricia Kluding, PhD, University of Kansas Medical Center
Study Sponsor  ICMJE Patricia Kluding, PhD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Patricia Kluding, PhD University of Kansas Medical Center
PRS Account University of Kansas Medical Center
Verification Date July 2013

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