Exercise and Nerve Function in Diabetes
Effectiveness of an Exercise Program on Nerve Function and Cutaneous Nerve Fibers in Adults With Type 2 Diabetes
2 other identifiers
interventional
26
1 country
1
Brief Summary
The purpose of this study is to describe the effect of a 10-week exercise program on nerve function and number of nerve fibers in the skin in the lower leg in people with diabetic neuropathy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 1, 2009
CompletedFirst Posted
Study publicly available on registry
September 2, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedJuly 4, 2013
July 1, 2013
1.3 years
September 1, 2009
July 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Quantitative sensory testing
10 weeks
Nerve conduction studies
10 weeks
Proprioception
10 weeks
Dermal and epidermal nerve fiber densities
10 weeks
Secondary Outcomes (1)
Clinical assessments of neuropathy, pain, body mass index, muscle strength, and glycemic control (glycosylated hemoglobin or A1C)
10 weeks
Study Arms (1)
Exercise program
EXPERIMENTALSupervised moderately-intense exercise, including both aerobic and strengthening activities. Sessions are 3-4 days per week for 10 weeks.
Interventions
Supervised moderately-intense exercise, including both aerobic and strengthening activities. Sessions are 3-4 days per week for 10 weeks.
Eligibility Criteria
You may qualify if:
- Age 40-70
- Type 2 diabetes
- Peripheral neuropathy
You may not qualify if:
- Serious cardiac history or other medical problems that would prevent safe participation in exercise
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Patricia Kluding PhD
Kansas City, Kansas, 66160, United States
Related Publications (1)
Kluding PM, Pasnoor M, Singh R, Jernigan S, Farmer K, Rucker J, Sharma NK, Wright DE. The effect of exercise on neuropathic symptoms, nerve function, and cutaneous innervation in people with diabetic peripheral neuropathy. J Diabetes Complications. 2012 Sep-Oct;26(5):424-9. doi: 10.1016/j.jdiacomp.2012.05.007. Epub 2012 Jun 18.
PMID: 22717465DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patricia Kluding, PhD
University of Kansas Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 1, 2009
First Posted
September 2, 2009
Study Start
June 1, 2008
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
July 4, 2013
Record last verified: 2013-07