Pilot Study of Exercise and Peripheral Nerve Function in People With Diabetes - Exercise and Neuropathy Research Group v.2 (ENRGy2) Addendum
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Change in aerobic fitness
研究概览
简要总结
This is an amendment to study posting NCT00970060. Based on preliminary results from that study is was determined there needs to be a follow-up exercise intervention study. This study has two additional aims than the original study. The objectives are to determine is a prolonged exercise routine, 16-weeks, paired with refined measures of effectiveness positively impact people with diabetic neuropathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40-70
- •Type 2 diabetes
- •Peripheral neuropathy
排除标准
- •serious cardiac pathology such as recent myocardial infarction or heart surgery, uncontrolled cardiac arryhthmia, hypertrophic cardiomyopathy symptomatic aortic stenosis or heart failure, unstable angina, acute pulmonary embolus or myocarditis, conduction abnormalities, or mitral valve prolapse
- •serious musculoskeletal problems that would limit ability to exercise
- •skin conditions, circulatory insufficiency, or open wounds in the leg that would interfere with healing from the biopsy
- •open wounds on the weight bearing surface of the feet
- •not able to ambulate independently
- •stroke or other central nervous system pathology
- •stage 2 hypertension (resting blood pressure > 160 systolic or > 100 diastolic)
- •lidocaine allergy
- •anticipated difficulty with blood clotting due to Coumadin(Warfarin) use or blood clotting disorder
- •body weight > 450 lbs
- •inadequate cognition and communication abilities, defined as < 24 on the Mini Mental Status Exam (MMSE)
- •pregnant or planning on becoming pregnant in the 18 weeks following enrollment
结局指标
主要结局
Change in aerobic fitness
时间窗: Baseline to Week 16
Aerobic fitness will be assessed with a graded maximal exercise test as in the previous protocol with a metabolic cart and integrated ECG.
Change nerve function
时间窗: Baseline to Week 16
Change in nerve function will be quantified using the Total Neuropathy Score (TNS). The TNS is a composite measure of peripheral nerve function that includes grading of signs/symptoms, nerve conduction studies, and quantitative sensory testing. We will not include proprioceptive testing in this project.
次要结局
- Change in maximal workload(Baseline to Week 16)
- Change in pain experienced(Baseline to Week 16)
- Change in cutaneous innervation(Baseline to Week 16)
研究者
Patricia Kluding, PhD
Associate Professor
University of Kansas