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

NCT ID: NCT01764373

Last Updated: 2013-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetic Neuropathy

Keywords

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Pain Fitness Diabetes Aerobic Exercise

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Aerobic Exercise

Intervention Type OTHER

Aerobic exercises in the program include cycle ergometers, treadmills, recumbent steppers and elliptical trainers.

Interventions

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Aerobic Exercise

Aerobic exercises in the program include cycle ergometers, treadmills, recumbent steppers and elliptical trainers.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Kansas

OTHER

Sponsor Role lead

Responsible Party

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Patricia Kluding, PhD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patricia Kluding, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 25278335 (View on PubMed)

Related Links

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http://clinicaltrials.gov/ct2/show/NCT00970060

Original Protocol Study Posting

Other Identifiers

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ENRGy2 Addendum

Identifier Type: -

Identifier Source: org_study_id