| City: |
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Hines |
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State:
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IL |
| Zip Code: |
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60141 |
| Conditions: |
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Diabetic Neuropathy |
| Purpose: |
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This study will determine the type and combination of exercise needed to rehabilitate the
neuro-compromised diabetic Veteran. Guided exercise protocols may prove to be practical
therapeutic options for the prophylactic management of diabetic subjects with neuropathy.
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| Study summary: |
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Purpose: A single-site, randomized, blinded, prospective clinical trial is proposed to
determine the significance of a combined isokinetic strength and aerobic exercise training
program on the rehabilitation of peripheral nerve function in Type 2 diabetic veterans and
non-veterans with neuropathy. Background and Significance: Obesity is a major factor in the
increasing rates of diabetes and its related complications. Diabetes affects greater than 7%
of the population. Veterans are at even greater risk, with approximately 16% currently
receiving treatment at Department of Veterans Affairs Medical Centers for diabetes. More
than half of affected veterans experience debilitating complications of diabetes, including
peripheral neuropathy (PN). Exercise training, in combination with pharmacologic
intervention, is now recognized as a cornerstone of management for diabetes. Therapeutic
interventions currently available for the treatment of PN in diabetic patients are limited,
however, to pain management and stringent glycemic control. Exercise is reported to
significantly decrease peripheral nerve microvascular complications common among chronic
diabetics. Our preliminary findings demonstrate that exercise intervention improves
peripheral nerve function in the diabetic veteran with PN. Intervention strategies, such as
proposed in this application, offer a unique and novel therapeutic option for the
rehabilitation of the neuro-compromised Type 2 diabetic veterans and non-veterans. Methods
& Research Plan: One-hundred subjects will be recruited for this 24-week study. Subjects
each will be randomly assigned to aerobic, isokinetic strength training, combined aerobic
and strength training, or non-exercise (control) intervention groups. Isokinetic strength
training (Biodex System 3), aerobic exercise training (treadmill), or the combination of
strength and aerobic training will be administered 3x per week for the initial 12 weeks.
Control subjects will receive 12 clinical visits over the course of the initial 12 weeks.
The effects of exercise training type, compared with control subjects, on recovery of
peripheral nerve function will be rigorously determined from baseline, 12- and 24-week
testing using electrodiagnostic primary outcome measures, Quantitative Sensory Testing, and
a battery of validated qualitative and quantitative secondary outcome measures that include
an incremental symptom-limited treadmill test, peak torque, Total Neuropathy Score, visual
analogue pain scale, and quality of life SF-36V Health Survey. Sustainability of effect will
be determined at 24-weeks.The individual effects of exercise training type, compared with
control subjects, on tissue oxygenation will be determined from baseline, 12- and 24-week
testing by non-invasive quantitated infrared spectroscopy using an InSpectraTM Tissue
Spectrometer. Expected Outcomes: This study will objectively and critically determine the
type and combination of exercise needed to rehabilitate the neuro-compromised diabetic
Veteran. Guided exercise protocols may prove to be practical therapeutic options for the
prophylactic management of diabetic subjects with neuropathy. |
| Criteria: |
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Inclusion Criteria:
- Clinical diagnosis of type 2 diabetes mellitus
- stable blood glucose control
- clinical findings consistent with length-dependent sensorimotor polyneuropathy, stage
N2a
Exclusion Criteria:
- foot ulceration
- unstable heart disease
- co-morbid conditions limiting exercise
- disorders of the central nervous system causing weakness or sensory loss
- received treatment with medications known to have neuropathy as a prominent side
effect including vincristine, vinblastine, cis-platin, and paclitaxel
- medical conditions that may be associated with neuropathies such as alcoholism, liver
disease, kidney disease, toxic exposure, vitamin deficiency, autoimmune disorders,
cancer, or hypothyroidism |
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| Study is available at: |
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Edward Hines, Jr. VA Hospital
Hines, IL 60141
United States
Primary Contact:
Evan Stubbs
Email: evan.stubbs@va.gov
Phone: 708-202-8387
Secondary Contact:
Mazy Miller, RN
Email: mazy.miller@va.gov
Phone: (708) 202-4171 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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