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

Not Applicable

Completed

• Conditions: Diabetic Neuropathy
• Interventions: Other: Aerobic Exercise

• Registration Number: NCT01764373
• Lead Sponsor: University of Kansas

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2013-01-07
• Study First Submitted QC: 2013-01-07
• Study First Posted: 2013-01-09
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-26
• Last Update Posted: 2013-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
16-Week Exercise Program	Aerobic Exercise	Subjects to participate in 16-week3 supervised aerobic exercise 3 times per week. Exercise sessions to last between 30 and 60 minutes.

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States