- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01764373
Pilot Study of Exercise and Peripheral Nerve Function in People With Diabetes - ENRGy2 Addendum
September 26, 2013 updated by: Patricia Kluding, PhD, University of Kansas
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kansas
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Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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Aerobic exercises in the program include cycle ergometers, treadmills, recumbent steppers and elliptical trainers.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change nerve function
Time Frame: Baseline to Week 16
|
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.
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Baseline to Week 16
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Change in aerobic fitness
Time Frame: Baseline to Week 16
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Aerobic fitness will be assessed with a graded maximal exercise test as in the previous protocol with a metabolic cart and integrated ECG.
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Baseline to Week 16
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in cutaneous innervation
Time Frame: Baseline to Week 16
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Change will be measured after exercise intervention to see what effects exercise has on dermal and epidermal innervation.
Change measured via skin biopsy.
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Baseline to Week 16
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Change in maximal workload
Time Frame: Baseline to Week 16
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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.
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Baseline to Week 16
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Change in pain experienced
Time Frame: Baseline to Week 16
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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.
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Baseline to Week 16
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Patricia Kluding, PhD, University of Kansas Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (Actual)
July 1, 2013
Study Completion (Actual)
July 1, 2013
Study Registration Dates
First Submitted
January 7, 2013
First Submitted That Met QC Criteria
January 7, 2013
First Posted (Estimate)
January 9, 2013
Study Record Updates
Last Update Posted (Estimate)
September 27, 2013
Last Update Submitted That Met QC Criteria
September 26, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ENRGy2 Addendum
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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