Effect of Weight-Bearing Exercise on People With Diabetes and Neuropathic Feet
Completed · Not applicable
Conditions studied: Diabetes Mellitus, Peripheral Neuropathy
In brief
The purpose of this study is to determine if people with Diabetes Mellitus and peripheral neuropathy can increase their activity (i.e. walking or stationary biking) and leg strength without having an increase in foot problems compared to a group of people with diabetes and peripheral neuropathy that do no exercise. Our hypothesis is that the weight-bearing exercise group will achieve greater increases in weight-bearing activity (i.e., increased steps/day and cumulative load) and leg strength compared to the non-weight bearing exercise group and the non-exercising control group; and there will be no clinically meaningful difference in incidence or indicators of foot lesions between groups.
Key facts
- Study ID
- NCT00763087
- Run by
- Washington University School of Medicine
- People needed
- 43
- Starts
- 2008-09-01
- Expected to finish
- 2011-01-01
- Last updated by the study team
- 2017-11-07
Who can join
Age: 40 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Type 1 or Type 2 DM and PN
- biothesiometer > 25mV and
- unable to sense the 5.07 Semmes Weinstein monofilament on at least one spot on the plantar foot
- Relatively sedentary
- step count of 2-9,000 steps per day
- exercising less than 3 times per week (<20 min/session).
- Have the approval of his/her primary care physician to participate in the study.
You may not qualify if…
- Subjects who weigh greater than 300 pounds (DXA scanner's weight limit).
- A history of severe foot deformity, such as Charcot neuroarthropathy or partial foot amputation that would require custom therapeutic footwear.
- Any co-morbidity or medication that would interfere with ability to exercise according to ADA and ACSM guidelines.
- People with severe depression as determined by the Beck Depression Inventory II with a score of 29 or greater.
- People who are physically incapable of tolerating one hour of activity.
- Women of child bearing age due to risk of exposure from radiation in DXA testing.
Where it is running
- Program in Physical Therapy, Washington University in St. Louis — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
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