Transcutaneous Spinal Electrical Stimulation to Improve Exercise Function After Spinal Cord Injury.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Oxygen uptake
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Oxygen uptake
时间窗: During individual study visits lasting between 1 and 2.5 hours
Oxygen uptake, in mL/min
Perceived Exertion
时间窗: 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.
Time to fatigue during incremental exercise tests to fatigue
时间窗: 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.
Heart rate
时间窗: During exercise testing study visits, lasting between 1 and 3 hours
Heart rate, beats per minute
Power output
时间窗: During exercise in study visits lasting 1 to 3 hours.
Watts
次要结局
- Muscle tissue oxygen saturation levels(Oxygen saturation levels will be assessed during study visits lasting between 1 and 2.5 hours.)
研究者
Kristine Cowley
Principal Investigator
University of Manitoba