Exercise and Nerve Function in Diabetes

July 3, 2013 updated by: Patricia Kluding, PhD

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Patricia Kluding PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quantitative sensory testing
Time Frame: 10 weeks
10 weeks
Nerve conduction studies
Time Frame: 10 weeks
10 weeks
Proprioception
Time Frame: 10 weeks
10 weeks
Dermal and epidermal nerve fiber densities
Time Frame: 10 weeks
10 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Patricia Kluding, PhD

Investigators

  • Principal Investigator: Patricia Kluding, PhD, University of Kansas Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

September 1, 2009

First Submitted That Met QC Criteria

September 1, 2009

First Posted (Estimate)

September 2, 2009

Study Record Updates

Last Update Posted (Estimate)

July 4, 2013

Last Update Submitted That Met QC Criteria

July 3, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11385
  • GCRC #105 (Other Identifier: Clinical and Translational Science Unit)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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