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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
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: June 2008
Estimated Study Completion Date: October 2009
Estimated 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

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00970060

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

No publications provided by University of Kansas

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Patricia Kluding PhD, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00970060     History of Changes
Other Study ID Numbers: 11385, GCRC #105
Study First Received: September 1, 2009
Last Updated: September 1, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
neuropathy
diabetes

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

ClinicalTrials.gov processed this record on May 16, 2013