Pilot Study of Exercise and Peripheral Nerve Function in People With Diabetes - ENRGy2 Addendum
|ClinicalTrials.gov Identifier: NCT01764373|
Recruitment Status : Completed
First Posted : January 9, 2013
Last Update Posted : September 27, 2013
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Neuropathy||Other: Aerobic Exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2013|
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.
- Change nerve function [ Time Frame: 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 [ Time Frame: 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 in cutaneous innervation [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01764373
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Patricia Kluding, PhD||University of Kansas Medical Center|