Exercise and Nerve Function in Diabetes

Diabetic Neuropathy Clinical Trial

Official title:

Effectiveness of an Exercise Program on Nerve Function and Cutaneous Nerve Fibers in Adults With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00970060
• Other study ID #: 11385
• Secondary ID: GCRC #105
• Status: Completed
• Phase: N/A
• First received: September 1, 2009
• Last updated: July 3, 2013
• Start date: June 2008
• Est. completion date: October 2009

Study information

• Verified date: July 2013
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Neuropathy

Intervention

Behavioral:
• Exercise
Supervised moderately-intense exercise, including both aerobic and strengthening activities. Sessions are 3-4 days per week for 10 weeks.

Locations

Country	Name	City	State
United States	Patricia Kluding PhD	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Patricia Kluding, PhD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantitative sensory testing		10 weeks	Yes
Primary	Nerve conduction studies		10 weeks	Yes
Primary	Proprioception		10 weeks	Yes
Primary	Dermal and epidermal nerve fiber densities		10 weeks	Yes
Secondary	Clinical assessments of neuropathy, pain, body mass index, muscle strength, and glycemic control (glycosylated hemoglobin or A1C)		10 weeks	Yes