Diabetic NeuropathyNCT00955201
Exercise-facilitated Neurorehabilitation in Diabetic Neuropathy
A study testing Exercise in people with Diabetic Neuropathy, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Diabetic Neuropathy
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2010to 14 Nov 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of type 2 diabetes mellitus
- stable blood glucose control
- clinical findings consistent with length-dependent sensorimotor polyneuropathy, stage N2a
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-5000
About this study
Official title: Exercise-Facilitated NeuroRehabilitation in Diabetic Neuropathy
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.
Read the 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.
- Conditions
- Diabetic Neuropathy
- Being tested
- Exercise
- Keywords
- diabetes mellitus, diabetic neuropathies, Aerobic Exercise, Exercise Therapy, electromyography, United States Veterans
- Medical subject headings
- Diabetic Neuropathies, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Structured aerobic exercise (treadmill).
ExerciseBehavioural
Structured isokinetic strength exercise (dynameter).
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | No intervention | Sedentary Control Group |
| Arm 2 | Experimental | Aerobic Exercise Group Receives: Behavioral: Exercise |
| Arm 3 | Experimental | Isokinetic Strength Exercise Group Receives: Behavioral: Exercise |
| Arm 4 | Experimental | Combined Aerobic and Isokinetic Strength Exercise Group Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sural Nerve Amplitude
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Measured: Baseline, 12, and 24 weeks
Sural Nerve Latency
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Measured: Baseline, 12 wks, 24 wks
Sural Nerve Conduction Velocity
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Measured: Baseline, 12 wks, 24 wks
Tibial Nerve Amplitude
Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Measured: Baseline, 12 weeks, 24 weeks
Tibial Nerve Latency
Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Measured: Baseline, 12 weeks, 24 weeks
Tibial Nerve Conduction Velocity
Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Measured: Baseline, 12 weeks, 24 weeks
Sensory Median Nerve Amplitude
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Measured: Baseline, 12, and 24 weeks
Sensory Median Nerve Latency
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Measured: Baseline, 12wks, 24 wks
Sensory Median Nerve Conduction Velocity
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Measured: Baseline, 12 wks, 24 wks
Sensory Ulnar Nerve Amplitude
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Measured: Baseline, 12 wks, 24 wks
Sensory Ulnar Nerve Latency
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Measured: Baseline, 12 wks, 24 wks
Sensory Ulnar Nerve Conduction Velocity
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Measured: Baseline, 12 wks, 24 wks
Peroneal Nerve Amplitude
Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Measured: Baseline, 12 wks, 24 wks
Peroneal Nerve Latency
Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Measured: Baseline, 12 wks, 24 wks
Peroneal Nerve Conduction Velocity
Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Measured: Baseline, 12 wks, 24 wks
Secondary outcomes (11)
Symptom-Limited TMT Blood Glucose Response
Changes in blood glucose in response to modified Bruce Protocol treadmill test (TMT)
Measured: Initial entry into study, 12 and 24 weeks
Short Form-36V: Physical Component Score
The short form-36Veterans (SF-36V) health survey questionnaire was used to measure health-related quality of life. This survey is comprised of eight subscales and two overall component scores, all of which have demonstrated high levels of internal consistency and discriminate validity when administered to groups of medically stable individuals. Patient aggregate responses for the eight distinct summary subscales and two component scores were compiled as a percentage of total points possible using the RAND 36-item health survey table. Data shown are expressed as a percentage of total possible score ranging from 0%-100% with 100% considered relatively good health and 0% considered poor health. Physical Component scores reflect perceived changes in physical health relative to the previous year.
Measured: Initial entry into study, 12 and 24 weeks
Voluntary Duration of Symptom-Limited TMT
Total time subjects voluntarily exercised while undergoing a modified Bruce Protocol treadmill test (TMT)
Measured: baseline, 12-wks, 24-wks
Symptom-Limited TMT Maximum Heart Rate
Peak heart rate achieved while undergoing a modified Bruce Protocol treadmill test (TMT)
Measured: baseline, 12-wks, 24-wks
Symptom-Limited TMT Maximum Systolic Blood Pressure
Peak systolic BP achieved while undergoing a modified Bruce Protocol treadmill test (TMT)
Measured: Baseline, 12-wk, 24-wk
Symptom-Limited TMT Maximum Minute Ventilation (VE)
Peak volume of air exchanged per minute achieved while undergoing a modified Bruce Protocol treadmill test (TMT)
Measured: Baseline, 12-wks, 24-wks
Symptom-Limited TMT Maximum Oxygen Uptake (VO2)
Peak Oxygen uptake achieved while undergoing a modified Bruce Protocol treadmill test (TMT)
Measured: Baseline, 12-wks, 24-wks
Maximum Respiratory Exchange Ratio (RER) During TMT
Peak RER achieved while undergoing a modified Bruce Protocol treadmill test (TMT). This is a mathematical ratio of maximally achieved (peak) VCO2 divided by maximally achieved (peak) VO2.
Measured: Baseline, 12-wks, 24-wks
Symptom-Limited TMT Maximum Carbon Dioxide Expelled (VCO2)
Peak Carbon Dioxide expelled achieved while undergoing a modified Bruce Protocol treadmill test (TMT)
Measured: Baseline, 12-wks, 24-wks
Symptom-Limited TMT Maximum METS Achieved (MET)
Peak metabolic rate equivalents (METS) achieved while undergoing a modified Bruce Protocol treadmill test (TMT). One MET is defined as the metabolic rate observed at rest, quantified as resting oxygen consumption of 250 ml/min (Male) or 200 ml /min (female). A value of 5 METS would represent a metabolic rate that is 5x that at rest and is considered an indicator of how hard a given individual is exercising. Data shown are expressed as a ratio at peak of exercise of oxygen consumed relative to normalized values for men or women at rest.
Measured: Baseline, 12-wks, 24-wks
Short Form-36V: Mental Component Score
The short form-36Veterans (SF-36V) health survey questionnaire was used to measure health-related quality of life. This survey is comprised of eight subscales and two overall component scores, all of which have demonstrated high levels of internal consistency and discriminate validity when administered to groups of medically stable individuals. Patient aggregate responses for the eight distinct summary subscales and two component scores were compiled as a percentage of total points possible using the RAND 36-item health survey table. Data shown are expressed as a percentage of total possible score ranging from 0%-100% with 100% considered relatively good health and 0% considered poor health. Mental Component scores reflect perceived changes in emotional health relative to the previous year.
Measured: initial entry into study, and at 12-wks and 24-wks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2009 (estimated)
- Study start14 Jan 2010
- Primary completion14 Nov 2014
- Study completion14 Nov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic NeuropathyStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Evan Stubbs, Principal investigator, Edward Hines Jr. VA Hospital, Hines, IL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00955201
- Sponsor's protocol ID
- B6954-R
- Other IDs
- I01RX000130
- Status last verified
- Sep 2019
- First submitted
- 6 Aug 2009
- Last updated
- 2 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Stubbs EB Jr, Fisher MA, Miller CM, Jelinek C, Butler J, McBurney C, Collins EG. Randomized Controlled Trial of Physical Exercise in Diabetic Veterans With Length-Dependent Distal Symmetric Polyneuropathy. Front Neurosci. 2019 Feb 11;13:51. doi: 10.3389/fnins.2019.00051. eCollection 2019.
PubMed 30804739
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise-Facilitated NeuroRehabilitation in Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT00955201
- Acronym / sponsor ID
- B6954-R
- Conditions
- Diabetic Neuropathy
- Keywords
- diabetes mellitus, diabetic neuropathies, Aerobic Exercise, Exercise Therapy, electromyography, United States Veterans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 14 Jan 2010 (actual)
- Primary completion
- 14 Nov 2014 (actual)
- Study completion
- 14 Nov 2014 (actual)
- First posted
- 10 Aug 2009 (estimated)
- Results
- Posted 2 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | No intervention | –Sedentary Control Group |
| Arm 2 | Experimental | Behavioral: ExerciseAerobic Exercise Group |
| Arm 3 | Experimental | Behavioral: ExerciseIsokinetic Strength Exercise Group |
| Arm 4 | Experimental | Behavioral: ExerciseCombined Aerobic and Isokinetic Strength Exercise Group |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of type 2 diabetes mellitus
- stable blood glucose control
- clinical findings consistent with length-dependent sensorimotor polyneuropathy, stage N2a
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseStructured aerobic exercise (treadmill). | Behavioural | Arm 2, Arm 4 |
| ExerciseStructured isokinetic strength exercise (dynameter). | Behavioural | Arm 3, Arm 4 |
Primary outcome
Sural Nerve Amplitude
Time frame: Baseline, 12, and 24 weeks
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Sural Nerve Latency
Time frame: Baseline, 12 wks, 24 wks
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Sural Nerve Conduction Velocity
Time frame: Baseline, 12 wks, 24 wks
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Tibial Nerve Amplitude
Time frame: Baseline, 12 weeks, 24 weeks
Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Tibial Nerve Latency
Time frame: Baseline, 12 weeks, 24 weeks
Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Tibial Nerve Conduction Velocity
Time frame: Baseline, 12 weeks, 24 weeks
Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Sensory Median Nerve Amplitude
Time frame: Baseline, 12, and 24 weeks
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Sensory Median Nerve Latency
Time frame: Baseline, 12wks, 24 wks
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Sensory Median Nerve Conduction Velocity
Time frame: Baseline, 12 wks, 24 wks
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Sensory Ulnar Nerve Amplitude
Time frame: Baseline, 12 wks, 24 wks
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Sensory Ulnar Nerve Latency
Time frame: Baseline, 12 wks, 24 wks
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Sensory Ulnar Nerve Conduction Velocity
Time frame: Baseline, 12 wks, 24 wks
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Peroneal Nerve Amplitude
Time frame: Baseline, 12 wks, 24 wks
Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Peroneal Nerve Latency
Time frame: Baseline, 12 wks, 24 wks
Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Peroneal Nerve Conduction Velocity
Time frame: Baseline, 12 wks, 24 wks
Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
11 secondary outcomes
Symptom-Limited TMT Blood Glucose Response
Time frame: Initial entry into study, 12 and 24 weeks
Short Form-36V: Physical Component Score
Time frame: Initial entry into study, 12 and 24 weeks
Voluntary Duration of Symptom-Limited TMT
Time frame: baseline, 12-wks, 24-wks
Symptom-Limited TMT Maximum Heart Rate
Time frame: baseline, 12-wks, 24-wks
Symptom-Limited TMT Maximum Systolic Blood Pressure
Time frame: Baseline, 12-wk, 24-wk
Symptom-Limited TMT Maximum Minute Ventilation (VE)
Time frame: Baseline, 12-wks, 24-wks
Symptom-Limited TMT Maximum Oxygen Uptake (VO2)
Time frame: Baseline, 12-wks, 24-wks
Maximum Respiratory Exchange Ratio (RER) During TMT
Time frame: Baseline, 12-wks, 24-wks
Symptom-Limited TMT Maximum Carbon Dioxide Expelled (VCO2)
Time frame: Baseline, 12-wks, 24-wks
Symptom-Limited TMT Maximum METS Achieved (MET)
Time frame: Baseline, 12-wks, 24-wks
Short Form-36V: Mental Component Score
Time frame: initial entry into study, and at 12-wks and 24-wks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30804739Stubbs EB Jr, Fisher MA, Miller CM, Jelinek C, Butler J, McBurney C, Collins EG. Randomized Controlled Trial of Physical Exercise in Diabetic Veterans With Length-Dependent Distal Symmetric Polyneuropathy. Front Neurosci. 2019 Feb 11;13:51. doi: 10.3389/fnins.2019.00051. eCollection 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evan Stubbs principal investigator
Edward Hines Jr. VA Hospital, Hines, IL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Diabetic Neuropathy, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sural Nerve Amplitude (time frame: Baseline, 12, and 24 weeks). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00955201, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2019.