The Effects of Electrical Muscle Stimulation (EMS) on Muscle Atrophy and Functional Outcomes in Critically Ill Patients; a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- feasibility of EMS treatment
研究概览
简要总结
Electrical muscle stimulation (EMS) is the therapy used to passively activate muscles using electrodes on the surface of the skin. EMS may be helpful in preserving muscle function in people who are on bedrest due to critical illness in the intensive care unit. The purpose of this study is to determine the safety and feasibility of implementing EMS in critically ill patients who are on mechanical ventilation for greater than 7 days, and examine the effects of 4 weeks of EMS on leg muscle size, muscle strength and functional outcomes in these patients. The investigators hypothesize that EMS will be safe and feasible and that critically ill patients receiving EMS will show a smaller loss of muscle size and strength than those in the control group, who do not receive EMS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •admitted to the medical-surgical ICU or cardiovascular ICU
- •walking independently prior to admission
- •mechanically ventilated for more than 7 days (i.e. prolonged ventilation)
- •receiving enteral or parenteral nutrition.
排除标准
- •history of neurological or psychiatric disease
- •primary muscle disease (e.g. muscular dystrophy, polymyositis)
- •catastrophic neurological event
- •receiving palliative care
- •contraindications to EMS (e.g. cardiac pacemaker/defibrillator, pregnancy, infected or cancerous lesions in proximity of electrode sites)
- •inadequate access to electrode sites due to medical devices
- •lower extremity edema affecting the thighs or buttocks
- •BMI > 35 kg/m2
- •allergies to adhesives or latex
结局指标
主要结局
feasibility of EMS treatment
时间窗: 4 weeks
the number of EMS treatments that are successfully applied will be expressed as a frequency of the total number of treatments attempted
次要结局
- muscle thickness(baseline, 2 weeks, 4 weeks)
- muscle strength(baseline, 2 weeks and 4 weeks)
研究者
Sunita Mathur
Principal Investigator
University Health Network, Toronto