Skip to main content
OpenTrials
Completed

NCT Number: NCT01764373

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetic Neuropathy Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Nutritional and Metabolic Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic Exercise

Other

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

Primary outcomes

  1. 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.

  2. Change in aerobic fitness

    Time frame: Baseline to Week 16

    Aerobic fitness will be assessed with a graded maximal exercise test as in the previous protocol with a metabolic cart and integrated ECG.

Secondary outcomes

  1. Change in cutaneous innervation

    Time frame: Baseline to Week 16

    Change will be measured after exercise intervention to see what effects exercise has on dermal and epidermal innervation. Change measured via skin biopsy.

  2. Change in maximal workload

    Time frame: Baseline to Week 16

    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.

  3. Change in pain experienced

    Time frame: Baseline to Week 16

    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.

Sponsors and collaborators

Lead sponsor

University of Kansas

Other

Registry information

Official study title

Pilot Study of Exercise and Peripheral Nerve Function in People With Diabetes - Exercise and Neuropathy Research Group v.2 (ENRGy2) Addendum

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 9, 2013
Registry last updated
Sep 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.