Exercise-facilitated Neurorehabilitation in Diabetic Neuropathy
Condition: Diabetic Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Exercise; Exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Structured aerobic exercise (treadmill).; Structured isokinetic strength exercise (dynameter).
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: diabetes mellitus; diabetic neuropathies; Aerobic Exercise; Exercise Therapy; electromyography; United States Veterans