Diabetic Neuropathy
Conditions
Keywords
Pain, Fitness, Diabetes, Aerobic Exercise
Brief summary
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.
Interventions
OTHERAerobic Exercise
Aerobic exercises in the program include cycle ergometers, treadmills, recumbent steppers and elliptical trainers.
Sponsors
University of Kansas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change nerve function | Baseline to Week 16 | 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. |
| Change in aerobic fitness | Baseline to Week 16 | Aerobic fitness will be assessed with a graded maximal exercise test as in the previous protocol with a metabolic cart and integrated ECG. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in cutaneous innervation | Baseline to Week 16 | Change will be measured after exercise intervention to see what effects exercise has on dermal and epidermal innervation. Change measured via skin biopsy. |
| Change in maximal workload | Baseline to Week 16 | Measured as part of the aerobic fitness assessment. Use of standardized protocol with total body recumbent stepped to be used to obtain the maximal workload. |
| Change in pain experienced | Baseline to Week 16 | Pain will be measured using the Brief Pain Inventory Short Form for diabetic peripheral neuropathy. This scale has been specifically validated in this population and consists of 3 pain severity items and a 7-item pain interference scale. |
Countries
United States
Outcome results
None listed