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

Diabetic Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01764373
• Other study ID #: ENRGy2 Addendum
• Status: Completed
• Phase: N/A
• First received: January 7, 2013
• Last updated: September 26, 2013
• Start date: June 2012
• Est. completion date: July 2013

Study information

• Verified date: September 2013
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Neuropathy

Intervention

Other:
• Aerobic Exercise
Aerobic exercises in the program include cycle ergometers, treadmills, recumbent steppers and elliptical trainers.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   Original Protocol Study Posting