N/A
N=45
Exercise-facilitated Neurorehabilitation in Diabetic Neuropathy
Diabetic Neuropathy
Bottom Line
View on ClinicalTrials.gov: NCT00955201 ↗Enrolled (actual)
45
Serious AEs
42.2%
Results posted
Oct 2019
Primary outcome: Primary: Sural Nerve Amplitude — 1.22; 2.37; 0.88; 0.86 uV — p=0.49
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Exercise (Behavioral)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sural Nerve Amplitude |
1.22; 2.37; 0.88; 0.86; 2.88; 1.49 | 0.49 |
| PRIMARY Sural Nerve Latency |
0.61; 1.01; 0.39; 0.64; 1.41; 1.04 | 0.53 |
| PRIMARY Sural Nerve Conduction Velocity |
6.21; 11.1; 3.27; 7.35; 16.46; 10.55 | 0.39 |
| PRIMARY Tibial Nerve Amplitude |
2.97; 3.71; 3.35; 4.71; 3.26; 3.03 | 0.98 |
| PRIMARY Tibial Nerve Latency |
4.37; 5.03; 4.43; 4.11; 4.15; 4.65 | 0.94 |
| PRIMARY Tibial Nerve Conduction Velocity |
31.81; 33.15; 30.0; 30.43; 32.56; 30.77 | 0.99 |
| PRIMARY Sensory Median Nerve Amplitude |
3.14; 5.55; 6.91; 7.18; 2.41; 6.00 | 0.91 |
| PRIMARY Sensory Median Nerve Latency |
1.66; 1.76; 3.36; 2.26; 1.54; 2.00 | 0.99 |
| PRIMARY Sensory Median Nerve Conduction Velocity |
18.95; 20.34; 35.05; 30.49; 18.18; 19.04 | 1.00 |
| PRIMARY Sensory Ulnar Nerve Amplitude |
4.48; 4.95; 5.60; 7.75; 4.68; 4.44 | 0.99 |
| PRIMARY Sensory Ulnar Nerve Latency |
2.25; 1.78; 1.50; 2.46; 1.82; 1.49 | 0.81 |
| PRIMARY Sensory Ulnar Nerve Conduction Velocity |
29.29; 24.68; 20.61; 39.27; 23.64; 20.59 | 0.83 |
| PRIMARY Peroneal Nerve Amplitude |
2.16; 2.33; 1.89; 2.79; 1.89; 1.55 | 0.96 |
| PRIMARY Peroneal Nerve Latency |
4.69; 4.93; 4.96; 4.65; 4.49; 4.85 | 0.98 |
| PRIMARY Peroneal Nerve Conduction Velocity |
30.58; 32.01; 32.97; 33.33; 29.07; 32.56 | 0.98 |
| SECONDARY Symptom-Limited TMT Blood Glucose Response |
157.3; 188.6; 181.5; 180.7; 129.3; 169.4 | 0.03 sig |
| SECONDARY Short Form-36V: Physical Component Score |
60.4; 52.3; 56.8; 59.1; 57.5; 86.4 | 1.00 |
| SECONDARY Voluntary Duration of Symptom-Limited TMT |
10.8; 11.9; 8.8; 11.0; 10.7; 13.4 | 1.00 |
| SECONDARY Symptom-Limited TMT Maximum Heart Rate |
128.5; 141.5; 135.5; 146.0; 125.8; 143.1 | 0.98 |
| SECONDARY Symptom-Limited TMT Maximum Systolic Blood Pressure |
190.5; 189.3; 196.3; 188.4; 196.0; 185.8 | 0.84 |
| SECONDARY Symptom-Limited TMT Maximum Minute Ventilation (VE) |
62.9; 63.5; 54.3; 62.0; 59.9; 67.0 | 0.87 |
| SECONDARY Symptom-Limited TMT Maximum Oxygen Uptake (VO2) |
17.4; 18.9; 16.5; 18.9; 17.0; 18.7 | 0.98 |
| SECONDARY Maximum Respiratory Exchange Ratio (RER) During TMT |
1.2; 1.2; 1.1; 1.1; 1.2; 1.2 | 0.97 |
| SECONDARY Symptom-Limited TMT Maximum Carbon Dioxide Expelled (VCO2) |
20.4; 22.0; 18.9; 20.7; 19.7; 21.9 | 0.95 |
| SECONDARY Symptom-Limited TMT Maximum METS Achieved (MET) |
5.0; 5.4; 4.7; 5.4; 4.9; 5.4 | 0.98 |
| SECONDARY Short Form-36V: Mental Component Score |
68.8; 63.6; 59.1; 61.4; 65.0; 72.7 | 1.00 |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00955201). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.