Pilot Study of Exercise and Peripheral Nerve Function in People With Diabetes - ENRGy2 Addendum
| Status: | Completed |
|---|---|
| Conditions: | Diabetic Neuropathy |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 40 - 70 |
| Updated: | 10/3/2013 |
| Start Date: | June 2012 |
| End Date: | July 2013 |
| Contact: | Patricia Kluding, PhD |
| Email: | pkluding@kumc.edu |
| Phone: | 913-588-6918 |
Pilot Study of Exercise and Peripheral Nerve Function in People With Diabetes - Exercise and Neuropathy Research Group v.2 (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.
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
We found this trial at
1
site
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
Click here to add this to my saved trials
