Exercise-facilitated Neurorehabilitation in Diabetic Neuropathy
20 september 2019 bijgewerkt door: VA Office of Research and Development
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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
45
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
Illinois
-
Hines, Illinois, Verenigde Staten, 60141-5000
- Edward Hines Jr. VA Hospital, Hines, IL
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
45 jaar tot 80 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Faculteitstoewijzing
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Geen tussenkomst: Arm 1
Sedentary Control Group
|
|
|
Experimenteel: Arm 2
Aerobic Exercise Group
|
Structured aerobic exercise (treadmill).
Structured isokinetic strength exercise (dynameter).
|
|
Experimenteel: Arm 3
Isokinetic Strength Exercise Group
|
Structured aerobic exercise (treadmill).
Structured isokinetic strength exercise (dynameter).
|
|
Experimenteel: Arm 4
Combined Aerobic and Isokinetic Strength Exercise Group
|
Structured aerobic exercise (treadmill).
Structured isokinetic strength exercise (dynameter).
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Sural Nerve Amplitude
Tijdsspanne: 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.
|
Baseline, 12, and 24 weeks
|
|
Sural Nerve Latency
Tijdsspanne: 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.
|
Baseline, 12 wks, 24 wks
|
|
Sural Nerve Conduction Velocity
Tijdsspanne: 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.
|
Baseline, 12 wks, 24 wks
|
|
Tibial Nerve Amplitude
Tijdsspanne: 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.
|
Baseline, 12 weeks, 24 weeks
|
|
Tibial Nerve Latency
Tijdsspanne: 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.
|
Baseline, 12 weeks, 24 weeks
|
|
Tibial Nerve Conduction Velocity
Tijdsspanne: 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.
|
Baseline, 12 weeks, 24 weeks
|
|
Sensory Median Nerve Amplitude
Tijdsspanne: 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.
|
Baseline, 12, and 24 weeks
|
|
Sensory Median Nerve Latency
Tijdsspanne: 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.
|
Baseline, 12wks, 24 wks
|
|
Sensory Median Nerve Conduction Velocity
Tijdsspanne: 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.
|
Baseline, 12 wks, 24 wks
|
|
Sensory Ulnar Nerve Amplitude
Tijdsspanne: 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.
|
Baseline, 12 wks, 24 wks
|
|
Sensory Ulnar Nerve Latency
Tijdsspanne: 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.
|
Baseline, 12 wks, 24 wks
|
|
Sensory Ulnar Nerve Conduction Velocity
Tijdsspanne: 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.
|
Baseline, 12 wks, 24 wks
|
|
Peroneal Nerve Amplitude
Tijdsspanne: 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.
|
Baseline, 12 wks, 24 wks
|
|
Peroneal Nerve Latency
Tijdsspanne: 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.
|
Baseline, 12 wks, 24 wks
|
|
Peroneal Nerve Conduction Velocity
Tijdsspanne: 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.
|
Baseline, 12 wks, 24 wks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Symptom-Limited TMT Blood Glucose Response
Tijdsspanne: Initial entry into study, 12 and 24 weeks
|
Changes in blood glucose in response to modified Bruce Protocol treadmill test (TMT)
|
Initial entry into study, 12 and 24 weeks
|
|
Short Form-36V: Physical Component Score
Tijdsspanne: Initial entry into study, 12 and 24 weeks
|
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.
|
Initial entry into study, 12 and 24 weeks
|
|
Voluntary Duration of Symptom-Limited TMT
Tijdsspanne: baseline, 12-wks, 24-wks
|
Total time subjects voluntarily exercised while undergoing a modified Bruce Protocol treadmill test (TMT)
|
baseline, 12-wks, 24-wks
|
|
Symptom-Limited TMT Maximum Heart Rate
Tijdsspanne: baseline, 12-wks, 24-wks
|
Peak heart rate achieved while undergoing a modified Bruce Protocol treadmill test (TMT)
|
baseline, 12-wks, 24-wks
|
|
Symptom-Limited TMT Maximum Systolic Blood Pressure
Tijdsspanne: Baseline, 12-wk, 24-wk
|
Peak systolic BP achieved while undergoing a modified Bruce Protocol treadmill test (TMT)
|
Baseline, 12-wk, 24-wk
|
|
Symptom-Limited TMT Maximum Minute Ventilation (VE)
Tijdsspanne: Baseline, 12-wks, 24-wks
|
Peak volume of air exchanged per minute achieved while undergoing a modified Bruce Protocol treadmill test (TMT)
|
Baseline, 12-wks, 24-wks
|
|
Symptom-Limited TMT Maximum Oxygen Uptake (VO2)
Tijdsspanne: Baseline, 12-wks, 24-wks
|
Peak Oxygen uptake achieved while undergoing a modified Bruce Protocol treadmill test (TMT)
|
Baseline, 12-wks, 24-wks
|
|
Maximum Respiratory Exchange Ratio (RER) During TMT
Tijdsspanne: Baseline, 12-wks, 24-wks
|
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.
|
Baseline, 12-wks, 24-wks
|
|
Symptom-Limited TMT Maximum Carbon Dioxide Expelled (VCO2)
Tijdsspanne: Baseline, 12-wks, 24-wks
|
Peak Carbon Dioxide expelled achieved while undergoing a modified Bruce Protocol treadmill test (TMT)
|
Baseline, 12-wks, 24-wks
|
|
Symptom-Limited TMT Maximum METS Achieved (MET)
Tijdsspanne: Baseline, 12-wks, 24-wks
|
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.
|
Baseline, 12-wks, 24-wks
|
|
Short Form-36V: Mental Component Score
Tijdsspanne: initial entry into study, and at 12-wks and 24-wks
|
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.
|
initial entry into study, and at 12-wks and 24-wks
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Height
Tijdsspanne: baseline
|
Height of subjects upon entry into study
|
baseline
|
|
Weight
Tijdsspanne: Baseline, 12-wks, 24-wks
|
Weight of subjects at baseline, 12-weeks, and 24-weeks
|
Baseline, 12-wks, 24-wks
|
|
Body Mass Index (BMI)
Tijdsspanne: Baseline, 12-wk, 24-wk
|
BMI is calculated as a ratio of subject body mass (kg) divided by the square of subject height (m).
|
Baseline, 12-wk, 24-wk
|
|
Duration of Diabetes Mellitus
Tijdsspanne: Baseline
|
Duration, in years, since first diagnosed with Diabetes Mellitus upon entry into study
|
Baseline
|
|
HbA1C Laboratory Values
Tijdsspanne: Baseline, 12-wk, 24-wk
|
Laboratory values of subject HbA1C levels at Baseline, 12-wk, 24-wk
|
Baseline, 12-wk, 24-wk
|
|
Triglyceride Laboratory Values
Tijdsspanne: Baseline
|
Laboratory triglyceride values at baseline entry into study
|
Baseline
|
|
Cholesterol Laboratory Values
Tijdsspanne: Baseline
|
Laboratory total cholesterol, HDL-cholesterol, and LDL-cholesterol levels at baseline entry into study
|
Baseline
|
|
Creatinine Laboratory Values
Tijdsspanne: Baseline
|
Laboratory creatinine values at baseline entry into study
|
Baseline
|
|
Blood Urea Nitrogen (BUN) Laboratory Values
Tijdsspanne: Baseline
|
Laboratory Blood Urea Nitrogen levels at baseline entry into study
|
Baseline
|
|
Aspartate Aminotransferase Laboratory Values
Tijdsspanne: Baseline
|
Laboratory values for Aspartate Aminotransferase (AST) at baseline entry into study
|
Baseline
|
|
Thyroid Stimulating Hormone Laboratory Values
Tijdsspanne: Baseline
|
Laboratory values for Thyroid Stimulating Hormone (TSH) at baseline entry into study
|
Baseline
|
|
Age
Tijdsspanne: at baseline
|
Age of participants at entry into study.
|
at baseline
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Evan Stubbs, Edward Hines Jr. VA Hospital, Hines, IL
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
14 januari 2010
Primaire voltooiing (Werkelijk)
14 november 2014
Studie voltooiing (Werkelijk)
14 november 2014
Studieregistratiedata
Eerst ingediend
6 augustus 2009
Eerst ingediend dat voldeed aan de QC-criteria
7 augustus 2009
Eerst geplaatst (Schatting)
10 augustus 2009
Updates van studierecords
Laatste update geplaatst (Werkelijk)
2 oktober 2019
Laatste update ingediend die voldeed aan QC-criteria
20 september 2019
Laatst geverifieerd
1 september 2019
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- B6954-R
- I01RX000130 (Subsidie/contract van de Amerikaanse NIH)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .