Clinical trial NCT01764373: Pilot Study of Exercise and Peripheral Nerve Function in People With Diabetes - ENRGy2 Addendum
Official title: Pilot Study of Exercise and Peripheral Nerve Function in People With Diabetes - Exercise and Neuropathy Research Group v.2 (ENRGy2) Addendum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Neuropathy
Keywords: Pain
Fitness
Diabetes
Aerobic Exercise
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2013-01-09
Enrollment: 19
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change nerve function
timeFrame: Baseline to Week 16
measure: Change in aerobic fitness
timeFrame: Baseline to Week 16
Secondary outcomes:
measure: Change in cutaneous innervation
timeFrame: Baseline to Week 16
measure: Change in maximal workload
timeFrame: Baseline to Week 16
measure: Change in pain experienced
timeFrame: Baseline to Week 16
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Patricia Kluding, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kluding PM, Pasnoor M, Singh R, D'Silva LJ, Yoo M, Billinger SA, LeMaster JW, Dimachkie MM, Herbelin L, Wright DE. Safety of aerobic exercise in people with diabetic peripheral neuropathy: single-group clinical trial. Phys Ther. 2015 Feb;95(2):223-34. doi: 10.2522/ptj.20140108. Epub 2014 Oct 2.