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

Kansas Board of Regents

Status: Completed

Conditions: Diabetic Neuropathy

Treatments: Other: Aerobic Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT01764373

ENRGy2 Addendum

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

19 participants in 1 patient group

16-Week Exercise Program

Experimental group

Description:

Subjects to participate in 16-week3 supervised aerobic exercise 3 times per week. Exercise sessions to last between 30 and 60 minutes.

Treatment:

Other: Aerobic Exercise