Pilot Study of Exercise and Peripheral Nerve Function in People With Diabetes - ENRGy2 Addendum
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 Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Pilot Study of Exercise and Peripheral Nerve Function in People With Diabetes - Exercise and Neuropathy Research Group v.2 (ENRGy2) Addendum|
- Change nerve function [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]Aerobic fitness will be assessed with a graded maximal exercise test as in the previous protocol with a metabolic cart and integrated ECG.
- Change in cutaneous innervation [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]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.
|Study Start Date:||June 2012|
|Study Completion Date:||July 2013|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Experimental: 16-Week Exercise Program
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
Aerobic exercises in the program include cycle ergometers, treadmills, recumbent steppers and elliptical trainers.
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Patricia Kluding, PhD||University of Kansas|