NCT01764373

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

September 27, 2013

Status Verified

September 1, 2013

Enrollment Period

1.1 years

First QC Date

January 7, 2013

Last Update Submit

September 26, 2013

Conditions

Diabetic Neuropathy

Keywords

PainFitnessDiabetesAerobic Exercise

Outcome Measures

Primary Outcomes (2)

  • Change nerve function

    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.

    Baseline to Week 16

  • Change in aerobic fitness

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

    Baseline to Week 16

Secondary Outcomes (3)

  • Change in cutaneous innervation

    Baseline to Week 16

  • Change in maximal workload

    Baseline to Week 16

  • Change in pain experienced

    Baseline to Week 16

Study Arms (1)

16-Week Exercise Program

EXPERIMENTAL

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

Interventions

Aerobic ExerciseOTHER

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

16-Week Exercise Program

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 40-70
  • Type 2 diabetes
  • Peripheral neuropathy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (1)

  • 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.

    PMID: 25278335DERIVED

Related Links

MeSH Terms

Conditions

Diabetic NeuropathiesPainDiabetes Mellitus

Interventions

Exercise

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsEndocrine System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Patricia Kluding, PhD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 7, 2013

First Posted

January 9, 2013

Study Start

June 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

September 27, 2013

Record last verified: 2013-09

Locations

US(1)