Exercise-facilitated Neurorehabilitation in Diabetic Neuropathy
20. září 2019 aktualizováno: 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.
Přehled studie
Postavení
Postavení
Dokončeno
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Detailní popis
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.
Typ studie
Typ studie
Intervenční
Zápis (Aktuální)
Zápis
45
Fáze
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
Illinois
-
Hines, Illinois, Spojené státy, 60141-5000
- Edward Hines Jr. VA Hospital, Hines, IL
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
45 let až 80 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Faktorové přiřazení
- Maskování: Singl
Počet zbraní
4
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
|---|---|
|
Žádný zásah: Arm 1
Sedentary Control Group
|
|
|
Experimentální: Arm 2
Aerobic Exercise Group
|
Structured aerobic exercise (treadmill).
Structured isokinetic strength exercise (dynameter).
|
|
Experimentální: Arm 3
Isokinetic Strength Exercise Group
|
Structured aerobic exercise (treadmill).
Structured isokinetic strength exercise (dynameter).
|
|
Experimentální: Arm 4
Combined Aerobic and Isokinetic Strength Exercise Group
|
Structured aerobic exercise (treadmill).
Structured isokinetic strength exercise (dynameter).
|
Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Sural Nerve Amplitude
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Symptom-Limited TMT Blood Glucose Response
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
|
Další výstupní opatření
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Height
Časové okno: baseline
|
Height of subjects upon entry into study
|
baseline
|
|
Weight
Časové okno: Baseline, 12-wks, 24-wks
|
Weight of subjects at baseline, 12-weeks, and 24-weeks
|
Baseline, 12-wks, 24-wks
|
|
Body Mass Index (BMI)
Časové okno: 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
Časové okno: Baseline
|
Duration, in years, since first diagnosed with Diabetes Mellitus upon entry into study
|
Baseline
|
|
HbA1C Laboratory Values
Časové okno: 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
Časové okno: Baseline
|
Laboratory triglyceride values at baseline entry into study
|
Baseline
|
|
Cholesterol Laboratory Values
Časové okno: Baseline
|
Laboratory total cholesterol, HDL-cholesterol, and LDL-cholesterol levels at baseline entry into study
|
Baseline
|
|
Creatinine Laboratory Values
Časové okno: Baseline
|
Laboratory creatinine values at baseline entry into study
|
Baseline
|
|
Blood Urea Nitrogen (BUN) Laboratory Values
Časové okno: Baseline
|
Laboratory Blood Urea Nitrogen levels at baseline entry into study
|
Baseline
|
|
Aspartate Aminotransferase Laboratory Values
Časové okno: Baseline
|
Laboratory values for Aspartate Aminotransferase (AST) at baseline entry into study
|
Baseline
|
|
Thyroid Stimulating Hormone Laboratory Values
Časové okno: Baseline
|
Laboratory values for Thyroid Stimulating Hormone (TSH) at baseline entry into study
|
Baseline
|
|
Age
Časové okno: at baseline
|
Age of participants at entry into study.
|
at baseline
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Sponzor
Vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Evan Stubbs, Edward Hines Jr. VA Hospital, Hines, IL
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
14. ledna 2010
Primární dokončení (Aktuální)
Primární dokončení
14. listopadu 2014
Dokončení studie (Aktuální)
Dokončení studie
14. listopadu 2014
Termíny zápisu do studia
První předloženo
První předloženo
6. srpna 2009
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
7. srpna 2009
První zveřejněno (Odhad)
První zveřejněno
10. srpna 2009
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
2. října 2019
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
20. září 2019
Naposledy ověřeno
Naposledy ověřeno
1. září 2019
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
Další identifikační čísla studie
- B6954-R
- I01RX000130 (Grant/smlouva NIH USA)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .