Exercise-facilitated Neurorehabilitation in Diabetic Neuropathy

This study is currently recruiting participants.
Verified by Department of Veterans Affairs, November 2010
First Received: August 6, 2009 Last Updated: November 15, 2010

Sponsor:
Department of Veterans Affairs
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00955201

Purpose
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
Diabetic Neuropathy Behavioral: Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment Official Title: Exercise-Facilitated NeuroRehabilitation in Diabetic Neuropathy

Further study details as provided by Department of Veterans Affairs:
Primary Outcome Measures:

  • Electrodiagnostic [ Time Frame: Initial entry into study, 12 and 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

  • aerobic capacity [ Time Frame: Initial entry into study, 12 and 24 weeks ] [ Designated as safety issue: No ]
  • quality of life, including pain perception and health care [ Time Frame: Initial entry into study, 12 and 24 weeks ] [ Designated as safety issue: No ]
  • isokinetic peak torque [ Time Frame: Initial entry into study, 12 and 24 weeks ] [ Designated as safety issue: No ]
  • tissue oxygen saturation [ Time Frame: Initial entry into study, 12 and 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2009
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: No Intervention
Sedentary Control Group
 
2: Experimental
Aerobic Exercise Group
Intervention: Behavioral: Exercise
Behavioral: Exercise
Structured aerobic exercise
(treadmill).
3: Experimental
Isokinetic Strength Exercise Group
Intervention: Behavioral: Exercise
Behavioral: Exercise
Structured isokinetic strength
exercise (dynameter).

4: Experimental
Combined Aerobic and Isokinetic
Strength Exercise Group
Interventions:

  • Behavioral: Exercise
  • Behavioral: Exercise

 

Behavioral: Exercise
Structured aerobic exercise
(treadmill).
Behavioral: Exercise
Structured isokinetic strength
exercise (dynameter).

 

 

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.

Eligibility
Ages Eligible for Study: 45 Years to 80 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria
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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