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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00955201 |
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.
Condition | Intervention |
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Diabetic Neuropathy |
Behavioral: Exercise |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Investigator), Factorial Assignment, Efficacy Study |
Official Title: | Exercise-Facilitated NeuroRehabilitation in Diabetic Neuropathy |
Estimated Enrollment: | 100 |
Study Start Date: | October 2009 |
Estimated Study Completion Date: | September 2013 |
Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: No Intervention
Sedentary Control Group
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2: Experimental
Aerobic Exercise Group
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Behavioral: Exercise
Structured aerobic exercise (treadmill).
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3: Experimental
Isokinetic Strength Exercise Group
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Behavioral: Exercise
Structured isokinetic strength exercise (dynameter).
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4: Experimental
Combined Aerobic and Isokinetic Strength Exercise Group
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Behavioral: Exercise
Structured aerobic exercise (treadmill).
Behavioral: Exercise
Structured isokinetic strength exercise (dynameter).
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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 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 diabetic veteran.
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.
Ages Eligible for Study: | 45 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Clara M Miller, RN | (708) 202-4171 | mazy.miller@va.gov |
Contact: Evan Stubbs | (708) 202-8387 | evan.stubbs@med.va.gov |
United States, Illinois | |
Edward Hines, Jr. VA Hospital | |
Hines, Illinois, United States, 60141-5000 |
Principal Investigator: | Evan Stubbs | Edward Hines Jr. VA Hospital |
Responsible Party: | Department of Veterans Affairs ( Stubbs, Evan - Principal Investigator ) |
Study ID Numbers: | B6954R, i01bx007080, 1i01rx000130-01 |
Study First Received: | August 6, 2009 |
Last Updated: | August 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00955201 History of Changes |
Health Authority: | United States: Federal Government |
diabetes mellitus diabetic neuropathies Aerobic Exercise |
Exercise Therapy electromyography United States Veterans |
Neuromuscular Diseases Diabetic Neuropathies Peripheral Nervous System Diseases Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Diabetes Complications |
Neuromuscular Diseases Diabetic Neuropathies Peripheral Nervous System Diseases Nervous System Diseases |
Diabetes Mellitus Endocrine System Diseases Diabetes Complications |