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

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Study of Exercise and Peripheral Nerve Function in People With Diabetes - Exercise and Neuropathy Research Group v.2 (ENRGy2) Addendum

Conditions
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Diabetic Neuropathy

Intervention / Treatment
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* Other: Aerobic Exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 16-Week Exercise Program<br>Subjects to participate in 16-week3 supervised aerobic exercise 3 times per week. Exercise sessions to last between 30 and 60 minutes. | Other: Aerobic Exercise<br>* Aerobic exercises in the program include cycle ergometers, treadmills, recumbent steppers and elliptical trainers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to Week 16 | 
| Change in aerobic fitness | Aerobic fitness will be assessed with a graded maximal exercise test as in the previous protocol with a metabolic cart and integrated ECG. | Baseline to Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cutaneous innervation | Change will be measured after exercise intervention to see what effects exercise has on dermal and epidermal innervation. Change measured via skin biopsy. | Baseline to Week 16 | 
| Change in maximal workload | 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. | Baseline to Week 16 | 
| Change in pain experienced | 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. | Baseline to Week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Aerobic Exercise, Pain, Fitness