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Exercise-facilitated Neurorehabilitation in Diabetic Neuropathy

2019년 9월 20일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

45

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • Illinois
      • Hines, Illinois, 미국, 60141-5000
        • Edward Hines Jr. VA Hospital, Hines, IL

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

45년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 요인 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
간섭 없음: Arm 1
Sedentary Control Group
실험적: Arm 2
Aerobic Exercise Group
행동: Exercise
Structured aerobic exercise (treadmill).
행동: Exercise
Structured isokinetic strength exercise (dynameter).
실험적: Arm 3
Isokinetic Strength Exercise Group
행동: Exercise
Structured aerobic exercise (treadmill).
행동: Exercise
Structured isokinetic strength exercise (dynameter).
실험적: Arm 4
Combined Aerobic and Isokinetic Strength Exercise Group
행동: Exercise
Structured aerobic exercise (treadmill).
행동: Exercise
Structured isokinetic strength exercise (dynameter).

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Sural Nerve Amplitude
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Symptom-Limited TMT Blood Glucose Response
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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

기타 결과 측정

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

VA Office of Research and Development

수사관

  • 수석 연구원: Evan Stubbs, Edward Hines Jr. VA Hospital, Hines, IL

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2010년 1월 14일

기본 완료 (실제)

2014년 11월 14일

연구 완료 (실제)

2014년 11월 14일

연구 등록 날짜

최초 제출

2009년 8월 6일

QC 기준을 충족하는 최초 제출

2009년 8월 7일

처음 게시됨 (추정)

2009년 8월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 10월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 9월 20일

마지막으로 확인됨

2019년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • B6954-R
  • I01RX000130 (미국 NIH 보조금/계약)

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다