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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Patricia Kluding, PhD, University of Kansas
ClinicalTrials.gov Identifier:
NCT01764373
First received: January 7, 2013
Last updated: September 26, 2013
Last verified: September 2013
  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.


Enrollment: 19
Study Start Date: June 2012
Study Completion Date: July 2013
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01764373

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas
Investigators
Principal Investigator: Patricia Kluding, PhD 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: September 26, 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 September 14, 2014