Exercise-facilitated Neurorehabilitation in Diabetic Neuropathy
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ClinicalTrials.gov Identifier: NCT00955201 |
Recruitment Status
: Unknown
Verified April 2015 by VA Office of Research and Development.
Recruitment status was: Active, not recruiting
First Posted
: August 10, 2009
Last Update Posted
: April 13, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetic Neuropathy | Behavioral: Exercise | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Treatment |
Official Title: | Exercise-Facilitated NeuroRehabilitation in Diabetic Neuropathy |
Study Start Date : | December 2009 |
Actual Primary Completion Date : | November 2014 |
Estimated Study Completion Date : | December 2016 |
Arm | Intervention/treatment |
---|---|
No Intervention: Arm 1
Sedentary Control Group
|
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Experimental: Arm 2
Aerobic Exercise Group
|
Behavioral: Exercise
Structured aerobic exercise (treadmill).
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Experimental: Arm 3
Isokinetic Strength Exercise Group
|
Behavioral: Exercise
Structured isokinetic strength exercise (dynameter).
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Experimental: Arm 4
Combined Aerobic and Isokinetic Strength Exercise Group
|
Behavioral: Exercise
Structured aerobic exercise (treadmill).
Behavioral: Exercise
Structured isokinetic strength exercise (dynameter).
|
- Electrodiagnostic [ Time Frame: Initial entry into study, 12 and 24 weeks ]
- aerobic capacity [ Time Frame: Initial entry into study, 12 and 24 weeks ]
- quality of life, including pain perception and health care [ Time Frame: Initial entry into study, 12 and 24 weeks ]
- isokinetic peak torque [ Time Frame: Initial entry into study, 12 and 24 weeks ]
- tissue oxygen saturation [ Time Frame: Initial entry into study, 12 and 24 weeks ]

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Ages Eligible for Study: | 45 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00955201
United States, Illinois | |
Edward Hines Jr. VA Hospital, Hines, IL | |
Hines, Illinois, United States, 60141-5000 |
Principal Investigator: | Evan Stubbs | Edward Hines Jr. VA Hospital, Hines, IL |
Responsible Party: | VA Office of Research and Development |
ClinicalTrials.gov Identifier: | NCT00955201 History of Changes |
Other Study ID Numbers: |
B6954-R 1I01RX000130-01 ( U.S. NIH Grant/Contract ) |
First Posted: | August 10, 2009 Key Record Dates |
Last Update Posted: | April 13, 2015 |
Last Verified: | April 2015 |
Keywords provided by VA Office of Research and Development:
diabetes mellitus diabetic neuropathies Aerobic Exercise |
Exercise Therapy electromyography United States Veterans |
Additional relevant MeSH terms:
Peripheral Nervous System Diseases Diabetic Neuropathies Neuromuscular Diseases Nervous System Diseases |
Diabetes Complications Diabetes Mellitus Endocrine System Diseases |