Pilot Study of Exercise and Peripheral Nerve Function in People With Diabetes - ENRGy2 Addendum
This study is currently recruiting participants.
Verified January 2013 by University of Kansas
Sponsor:
University of Kansas
Information provided by (Responsible Party):
Patricia Kluding, PhD, University of Kansas
ClinicalTrials.gov Identifier:
NCT01764373
First received: January 7, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Diabetic Neuropathy |
Other: Aerobic Exercise |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by University of Kansas:
Primary Outcome Measures:
- Change nerve function [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Aerobic fitness will be assessed with a graded maximal exercise test as in the previous protocol with a metabolic cart and integrated ECG.
Secondary Outcome Measures:
- Change in cutaneous innervation [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 30 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 40 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01764373
Contacts
| Contact: Patricia Kluding, PhD | 913-588-6918 | pkluding@kumc.edu |
Locations
| United States, Kansas | |
| University of Kansas Medical Center | Recruiting |
| Kansas City, Kansas, United States, 66160 | |
| Contact: Patricia Kluding, PhD 913-588-6918 pkluding@kumc.edu | |
Sponsors and Collaborators
University of Kansas
More Information
Additional Information:
No publications provided
| Responsible Party: | Patricia Kluding, PhD, Associate Professor, University of Kansas |
| ClinicalTrials.gov Identifier: | NCT01764373 History of Changes |
| Other Study ID Numbers: | ENRGy2 Addendum |
| Study First Received: | January 7, 2013 |
| Last Updated: | January 7, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Kansas:
|
Pain Fitness Diabetes Aerobic Exercise |
Additional relevant MeSH terms:
|
Diabetic Neuropathies Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases |
Diabetes Complications Diabetes Mellitus Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013