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This is an amendment to study posting NCT00970060. Based on preliminary results from that study is was determined there needs to be a follow-up exercise intervention study. This study has two additional aims than the original study. The objectives are to determine is a prolonged exercise routine, 16-weeks, paired with refined measures of effectiveness positively impact people with diabetic neuropathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 16-Week Exercise Program | Experimental | Subjects to participate in 16-week3 supervised aerobic exercise 3 times per week. Exercise sessions to last between 30 and 60 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerobic Exercise | Other | Aerobic exercises in the program include cycle ergometers, treadmills, recumbent steppers and elliptical trainers. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change nerve function | Change in nerve function will be quantified using the Total Neuropathy Score (TNS). The TNS is a composite measure of peripheral nerve function that includes grading of signs/symptoms, nerve conduction studies, and quantitative sensory testing. We will not include proprioceptive testing in this project. | Baseline to Week 16 |
| Change in aerobic fitness | Aerobic fitness will be assessed with a graded maximal exercise test as in the previous protocol with a metabolic cart and integrated ECG. | Baseline to Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cutaneous innervation | Change will be measured after exercise intervention to see what effects exercise has on dermal and epidermal innervation. Change measured via skin biopsy. | Baseline to Week 16 |
| Change in maximal workload |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia Kluding, PhD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25278335 | Derived | Kluding PM, Pasnoor M, Singh R, D'Silva LJ, Yoo M, Billinger SA, LeMaster JW, Dimachkie MM, Herbelin L, Wright DE. Safety of aerobic exercise in people with diabetic peripheral neuropathy: single-group clinical trial. Phys Ther. 2015 Feb;95(2):223-34. doi: 10.2522/ptj.20140108. Epub 2014 Oct 2. |
| Label | URL |
|---|---|
| Original Protocol Study Posting | View source |
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| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| D010146 | Pain |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Measured as part of the aerobic fitness assessment. Use of standardized protocol with total body recumbent stepped to be used to obtain the maximal workload.
| Baseline to Week 16 |
| Change in pain experienced | Pain will be measured using the Brief Pain Inventory Short Form for diabetic peripheral neuropathy. This scale has been specifically validated in this population and consists of 3 pain severity items and a 7-item pain interference scale. | Baseline to Week 16 |
| D004700 | Endocrine System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |