The Role of Neuromuscular Electrical Stimulation as a Tool for Post ICU Rehabilitation
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Muscle strength
研究概览
简要总结
The purpose of this study is to investigate the role of NEMS as a rehabilitation tool for muscle weakness following critical illness. The investigators hypothesized that NEMS combined with exercise rehabilitation will have a beneficial role in restoration of muscle strength
详细描述
Survivors of critical illness are presented with significant physical impairment that is associated with reduced functional ability and health -related quality of life both in the short and long-term.
Neuromuscular electrical stimulation (NEMS) has been proposed as an alternative exercise modality in patients with severe chronic obstructive pulmonary disease and chronic heart failure, who cannot perform active exercise. NEMS has also been used as a preventive tool for intensive care unit (ICU) acquired weakness (ICUAW). Its role as a tool for post ICU rehabilitation has not been evaluated so far.
A randomized intervention study was designed to assess the efficacy of NEMS, as a rehabilitative tool for critical illness survivors. The first day that patients are discharged from the ICU after stratified randomization are assigned to the NEMS group or to the control group. In the NEMS group, NEMS will be applied to both lower extremities of the NEMS -group simultaneously (quadriceps femoris muscle and peroneus longus) on a daily basis, along with a personalized exercise program. NEMS sessions will continue until patient discharge from hospital. In the control group, sham NEMS will be applied along with standard care when it comes to physiotherapy. At hospital discharge patients of both groups of will receive a rehabilitation booklet. Patients on the NEMS group that have significant muscle weakness will have NEMS sessions at home for a period of 2 months. Patients are evaluated at 3 and 6 months after hospital discharge
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients under mechanical ventilation for> 72hours during ICU stay
- •Patients able to perform simple commands (able to be evaluated by MRC scale)
排除标准
- •age < 18 > 85 years
- •pregnancy
- •pre-existing neuromuscular disease (e.g. Gravis)
- •fractures or skin lesions that do not allow the implementation of NEMS
- •presence of pacemaker or defibrillator
- •fractures of spine that so not allow mobilization
- •BMI > 35 kg/m2
- •terminal disease
研究组 & 干预措施
NEMS group
干预措施: NEMS (Procedure)
Sham group
干预措施: Sham (Procedure)
结局指标
主要结局
Muscle strength
时间窗: up to 2.5 years
次要结局
- Functional ability(up to 2.5 years)
- Quality of life(up to 2.5 years)
- Duration of hospital stay(up to 2.5 years)
研究者
Serafim Nanas
Professor
University of Athens