Pilot Study of Exercise and Peripheral Nerve Function in People With Diabetes - ENRGy2 Addendum

University of Kansas19 enrolled

Overview

This is an amendment to study posting NCT00970060. Based on preliminary results from that study is was determined there needs to be a follow-up exercise intervention study. This study has two additional aims than the original study. The objectives are to determine is a prolonged exercise routine, 16-weeks, paired with refined measures of effectiveness positively impact people with diabetic neuropathy.

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

Conditions

Diabetic Neuropathy

Interventions

Aerobic ExerciseOTHER

Aerobic exercises in the program include cycle ergometers, treadmills, recumbent steppers and elliptical trainers.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 40-70 * Type 2 diabetes * Peripheral neuropathy Exclusion Criteria: * serious cardiac pathology such as recent myocardial infarction or heart surgery, uncontrolled cardiac arryhthmia, hypertrophic cardiomyopathy symptomatic aortic stenosis or heart failure, unstable angina, acute pulmonary embolus or myocarditis, conduction abnormalities, or mitral valve prolapse * serious musculoskeletal problems that would limit ability to exercise * skin conditions, circulatory insufficiency, or open wounds in the leg that would interfere with healing from the biopsy * open wounds on the weight bearing surface of the feet * not able to ambulate independently * stroke or other central nervous system pathology * stage 2 hypertension (resting blood pressure \> 160 systolic or \> 100 diastolic) * lidocaine allergy * anticipated difficulty with blood clotting due to Coumadin(Warfarin) use or blood clotting disorder * body weight \> 450 lbs * inadequate cognition and communication abilities, defined as \< 24 on the Mini Mental Status Exam (MMSE) * pregnant or planning on becoming pregnant in the 18 weeks following enrollment

Locations (1)

University of Kansas Medical Center

Kansas City, Kansas, United States

Outcomes

Primary Outcomes

Change nerve function

Change in nerve function will be quantified using the Total Neuropathy Score (TNS). The TNS is a composite measure of peripheral nerve function that includes grading of signs/symptoms, nerve conduction studies, and quantitative sensory testing. We will not include proprioceptive testing in this project.