Transcutaneous Spinal Electrical Stimulation to Improve Exercise Function After Spinal Cord Injury.
Our overall objective is to decrease the prevalence of multiple sedentary-related diseases that are secondary consequences of spinal cord injury (SCI). SCI affects motor, sensory and autonomic systems and can cause very limited exercise capacity which then leads to very high rates of obesity, metabolic syndrome, type II diabetes and cardiovascular disease.
This randomized controlled study aims to determine whether and how transcutaneous spinal electrical stimulation (TSES) alters acute (immediate) exercise responses in people living with SCI. Exercise responses will be tested during incremental tests to fatigue, and during steady state tests. Testing will occur over several study visits and results will be compared within each individual as well as between groups (tetraplegia and paraplegia) and to a group of reference controls. A number of outcomes will be monitored, including whole-body metabolic responses using a metabolic cart, muscle responses using EMG sensors and muscle oxygenation using near infrared spectroscopy (NIRS) sensors, time to fatigue, power output, as well as perceptions about fatigue and effort.
The findings of this study are expected to provide evidence regarding whether and how TSES might improve acute exercise responses in people living with SCI.
研究概览
详细说明
It is well understood that SCI causes motor paralysis and sensory loss. However, it is the loss of autonomic regulation that confers the greatest morbidity to those living with SCI. Impaired exercise responses, including limited peak HR, oxygen uptake, limited catecholamine related to impaired activation of spinal sympathetic autonomic systems. Depending upon level of injury, and these sub-optimal exercise responses, there are limited exercise training effects which then leads to a calorie excess and related weight gain, cardiovascular, skeletal muscle and metabolic deconditioning that eventually causes obesity, type II diabetes and cardiovascular disease.
These sedentary-related diseases likely result in large part, because of inadequate activation of these tissues with sufficient duration or intensity to result in training effects. Therefore, we are interested in identifying means to improve acute exercise responses, with an ultimate goal of improving training responses and reducing the incidence of and/or trajectory of developing these sedentary-related diseases in individuals with SCI.
TSES has recently emerged as a potential therapeutic method to improve exercise responses. In case studies it has been shown to increase peak responses and time to fatigue during arm ergometry exercise tests.
This study is designed as a prospective, single-center, randomized controlled trial to examine whether and how TSES might alter exercise responses in two groups of people with SCI (tetraplegia and paraplegia) and a reference control group from the general population. The study is designed to assess within individual and between-group responses for a variety of outcome measures during peak and steady-state exercise tests. Study visits occur over several weeks for each participant, according to each person's time and convenience availability.
Outcomes are assessed during exercise with and without TSES in the following 4 experimental conditions:
- Comparing peak incremental tests to voluntary upper body exercise fatigue with or without TSES.
- Comparing steady state exercise responses performed at 40-45% peak power output with or without TSES.
- Comparing time to fatigue during neuromuscular electrical stimulation (NMES) evoked rhythmic leg contractions with or without TSES.
The primary hypothesis is that TSES will improve a variety of exercise outcomes under different experimental testing conditions and that those with tetraplegia will benefit most.
The results of this study are expected to contribute to whether and how TSES might alter acute exercise responses in those living with SCI.
The results of this study are expected to contribute to the evidence base regarding the effectiveness of TSES to alter peak and steady-state exercise responses in people with SCI and may support its integration into standard exercise training or competitive sport protocols for individuals with SCI.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Kristine C Cowley, PhD
- 电话号码:+1 204-789-3305
- 邮箱:kristine.cowley@umanitoba.ca
研究联系人备份
- 姓名:Rodrigo Villar, PhD
- 电话号码:+1-204-474-8590
- 邮箱:rodrigo.villar@umanitoba.ca
学习地点
-
-
Manitoba
-
Winnipeg、Manitoba、加拿大、R3E 0J9
- 招聘中
- University of Manitoba
-
接触:
- Kristine Cowley, PhD
- 电话号码:+1-204-789-3305
- 邮箱:kristine.cowley@umanitoba.ca
-
首席研究员:
- Kristine Cowley, PhD
-
首席研究员:
- Rodrigo Villar, PhD
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- traumatic or non-traumatic spinal cord injury
- Spinal cord injury of at least one year duration, C5 or lower, AIS A - D
- medically stable and healthy enough to engage in and complete exercise requirements
- willing and able to complete the exercise protocols and testing requirements
- able to understand and follow written and verbal instructions from study staff
- able to communicate with study staff about their exercise capabilities and preferences
Exclusion Criteria:
- current serious injury (ies) of the upper extremities
- known cardiovascular disease
- unsatisfactory results of EKG screening
- implanted electronic cardiac devices (e.g., pacemaker, defibrillator, etc.)
- current pressure ulcer(s)
- morbid obesity
- known thyroid dysfunction
- current cancer
- current uncontrolled high blood pressure
- uncontrolled epilepsy
- current deep vein thrombosis
- ventilator dependency
- cognitive impairment
学习计划
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他:Upper body exercise in participants with tetraplegia
TSES during peak and steady state exercise in those with tetraplegia
|
TSES will typically involve constant current rectangular pulse bipolar stimulation delivered at 20 Hz with stimulation durations of 900 microseconds delivered at or slightly above motor threshold.
|
|
其他:Upper body exercise in participants with paraplegia
TSES during peak and steady state exercise in those with paraplegia
|
TSES will typically involve constant current rectangular pulse bipolar stimulation delivered at 20 Hz with stimulation durations of 900 microseconds delivered at or slightly above motor threshold.
|
|
其他:Upper body exercise in reference control participants
TSES during peak and steady state exercise in reference controls
|
TSES will typically involve constant current rectangular pulse bipolar stimulation delivered at 20 Hz with stimulation durations of 900 microseconds delivered at or slightly above motor threshold.
|
|
其他:Rhythmic lower limb neuromuscular electrical stimulation evoked exercise
Does TSES alter time to fatigue during NMES-evoked rhythmic lower limb exercise?
|
TSES will typically involve constant current rectangular pulse bipolar stimulation delivered at 20 Hz with stimulation durations of 900 microseconds delivered at or slightly above motor threshold.
|
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 |
|---|---|---|
|
Oxygen uptake
大体时间:During individual study visits lasting between 1 and 2.5 hours
|
Oxygen uptake, in mL/min
|
During individual study visits lasting between 1 and 2.5 hours
|
|
Perceived Exertion
大体时间:Tested intermittently during individual voluntary exercise study visits lasting between 1 and 2.5 hours
|
Ratings of perceived exertion, on a Borg scale of 6 to 20 with 6 being resting to 20 which is very very hard.
|
Tested intermittently during individual voluntary exercise study visits lasting between 1 and 2.5 hours
|
|
Time to fatigue during incremental exercise tests to fatigue
大体时间:Time to fatigue will be monitored during study visits lasting between 1 and 2.5 hours.
|
Does TSES alter time to fatigue during NMES-evoked rhythmic lower limb exercise, measured in seconds.
|
Time to fatigue will be monitored during study visits lasting between 1 and 2.5 hours.
|
|
Heart rate
大体时间:During exercise testing study visits, lasting between 1 and 3 hours
|
Heart rate, beats per minute
|
During exercise testing study visits, lasting between 1 and 3 hours
|
|
Power output
大体时间:During exercise in study visits lasting 1 to 3 hours.
|
Watts
|
During exercise in study visits lasting 1 to 3 hours.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Muscle tissue oxygen saturation levels
大体时间:Oxygen saturation levels will be assessed during study visits lasting between 1 and 2.5 hours.
|
Does TSES alter muscle tissue oxygen saturation levels during exercise, expressed as a percentage.
|
Oxygen saturation levels will be assessed during study visits lasting between 1 and 2.5 hours.
|
合作者和调查者
调查人员
- 首席研究员:Kristine Cowley, Phd、University of Manitoba
- 首席研究员:Rodrigo Villar, PhD、University of Manitoba
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- HS26003
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.