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Exercise-facilitated Neurorehabilitation in Diabetic Neuropathy

2019年9月20日更新者：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.

研究概览

地位

完全的

条件

糖尿病神经病变

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

阶段

不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

美国
- Illinois
  - Hines、Illinois、美国、60141-5000
    - Edward Hines Jr. VA Hospital, Hines, IL

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

45年至 80年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化
介入模型：阶乘赋值
屏蔽：单身的

手臂数量

武器和干预

参与者组/臂	干预/治疗
无干预：Arm 1 Sedentary Control Group
实验性的：Arm 2 Aerobic Exercise Group	行为的：Exercise Structured aerobic exercise (treadmill). 行为的：Exercise Structured isokinetic strength exercise (dynameter).
实验性的：Arm 3 Isokinetic Strength Exercise Group	行为的：Exercise Structured aerobic exercise (treadmill). 行为的：Exercise Structured isokinetic strength exercise (dynameter).
实验性的：Arm 4 Combined Aerobic and Isokinetic Strength Exercise Group	行为的：Exercise Structured aerobic exercise (treadmill). 行为的：Exercise Structured isokinetic strength exercise (dynameter).

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Sural Nerve Amplitude 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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

次要结果测量

结果测量	措施说明	大体时间
Symptom-Limited TMT Blood Glucose Response 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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) 大体时间：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) 大体时间：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 大体时间：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) 大体时间：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) 大体时间：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 大体时间：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

其他结果措施

结果测量	措施说明	大体时间
Height 大体时间：baseline	Height of subjects upon entry into study	baseline
Weight 大体时间：Baseline, 12-wks, 24-wks	Weight of subjects at baseline, 12-weeks, and 24-weeks	Baseline, 12-wks, 24-wks
Body Mass Index (BMI) 大体时间：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 大体时间：Baseline	Duration, in years, since first diagnosed with Diabetes Mellitus upon entry into study	Baseline
HbA1C Laboratory Values 大体时间：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 大体时间：Baseline	Laboratory triglyceride values at baseline entry into study	Baseline
Cholesterol Laboratory Values 大体时间：Baseline	Laboratory total cholesterol, HDL-cholesterol, and LDL-cholesterol levels at baseline entry into study	Baseline
Creatinine Laboratory Values 大体时间：Baseline	Laboratory creatinine values at baseline entry into study	Baseline
Blood Urea Nitrogen (BUN) Laboratory Values 大体时间：Baseline	Laboratory Blood Urea Nitrogen levels at baseline entry into study	Baseline
Aspartate Aminotransferase Laboratory Values 大体时间：Baseline	Laboratory values for Aspartate Aminotransferase (AST) at baseline entry into study	Baseline
Thyroid Stimulating Hormone Laboratory Values 大体时间：Baseline	Laboratory values for Thyroid Stimulating Hormone (TSH) at baseline entry into study	Baseline
Age 大体时间：at baseline	Age of participants at entry into study.	at baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

VA Office of Research and Development

调查人员

首席研究员：Evan Stubbs、Edward Hines Jr. VA Hospital, Hines, IL

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2010年1月14日

初级完成 (实际的)

2014年11月14日

研究完成 (实际的)

2014年11月14日

研究注册日期

首次提交

2009年8月6日

首先提交符合 QC 标准的

2009年8月7日

首次发布 (估计)

2009年8月10日

研究记录更新

最后更新发布 (实际的)

2019年10月2日

上次提交的符合 QC 标准的更新

2019年9月20日

最后验证

2019年9月1日

Exercise的临床试验

University of Maryland, Baltimore
National Institute on Aging (NIA)

完全的

BHS5 - 测试 Exercise Plus 计划的有效性 (Hip5)

髋部骨折

美国
Oregon Research Institute

主动，不招人

太极拳与轻度认知障碍老年人的认知功能

轻度认知障碍

美国
Cardinal Tien Hospital

完全的

血液透析期间的透析中运动

肾功能衰竭，慢性
Foundation University Islamabad

完全的

结构化运动方案对妊娠糖尿病的影响

妊娠糖尿病

巴基斯坦

Exercise-facilitated Neurorehabilitation in Diabetic Neuropathy