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Completed

NCT Number: NCT00970060

Exercise and Nerve Function in 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.

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Key information

Conditions

Diabetic Neuropathy Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nervous System Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Peripheral Nervous System Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Patricia Kluding PhD

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

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

Primary outcomes

  1. Quantitative sensory testing

    Time frame: 10 weeks

  2. Nerve conduction studies

    Time frame: 10 weeks

  3. Proprioception

    Time frame: 10 weeks

  4. Dermal and epidermal nerve fiber densities

    Time frame: 10 weeks

Secondary outcomes

  1. Clinical assessments of neuropathy, pain, body mass index, muscle strength, and glycemic control (glycosylated hemoglobin or A1C)

    Time frame: 10 weeks

Sponsors and collaborators

Lead sponsor

Patricia Kluding, PhD

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 2, 2009
Registry last updated
Jul 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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