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临床试验/NCT02602639
NCT02602639Unknown不适用

Development of a Spinal Cord Injury-specific Exercise-based Capacity

University of Manitoba1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
6
试验地点
1
主要终点
Peak VO2 (volume oxygen) output during exercise

研究概览

简要总结

Currently, those with spinal cord injury (SCI) demonstrate increased prevalence of obesity (75%) cardiovascular disease (30 - 50%), type II diabetes (21%) and osteoporosis in the legs (100%) when compared to the general population. It is important to identify the modes and intensities of exercise most likely to generate a reduction in these inactivity-related diseases in this population.

Therefore, the main purpose of this pilot research project is to implement and test a form of a spinal cord injury-specific exercise, known as FES rowing (FES: functional electrical stimulation).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Have a spinal cord injury, C5-T12 (level), AIS A-D (severity)
  • Be aged 18-75 for duration of study
  • Medically stable and healthy enough to complete exercise requirements
  • Willing and able to complete the at-home training requirements as prescribed
  • Willing and able to complete the exercise sessions as prescribed
  • Willing and able to complete the VO2 testing throughout the study
  • Willing and able to complete the DEXA (Dual-energy X-ray absorptiometry) scans during the study
  • Able to understand and follow written or verbal instructions from study staff

排除标准

  • Current pressure ulcer(s) at sites of electrical stimulation
  • Previous spontaneous or low-impact leg fracture
  • Previous diagnosis of cardiovascular disease (ie enlarged heart, heart murmur)
  • Unsatisfactory results of EKG (electrocardiogram) screening test
  • Known thyroid dysfunction
  • Kidney disease
  • Blood pressure > 140/90 mmHg
  • Currently taking blood pressure medication
  • History of epilepsy
  • Current hand, arm or shoulder injury
  • Current deep vein thrombosis
  • Implanted electronic cardiac device (pace maker, defibrillator, etc)
  • Ventilator-dependent
  • Unable to follow written and verbal instructions

结局指标

主要结局

Peak VO2 (volume oxygen) output during exercise

时间窗: 24 weeks compared to baseline

Peak VO2 testing will be performed before beginning rower training and again at the end of the 24 weeks of training. Testing will be performed with an arm ergometer, rowing without electrical stimulation, and rowing with electrical stimulation. This will assess energy use, time to fatigue, and perceived exertion.

次要结局

  • Leg EMG (electromyogram) while rowing(Throughout study (up to 36 weeks))
  • Body composition(24 weeks compared to baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kristine Cowley

Assistant Professor

University of Manitoba

研究点 (1)

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