Effects of Neuromuscular Electrical Stimulation Therapy on Physical Function in Patients With COVID-19 Associated Pneumonia: Study Protocol of a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Short Physical Performance Battery (SPPB) Score
研究概览
简要总结
Neuromuscular electrical stimulation (NMES) has been considered as a promising approach for the early rehabilitation of patients in and/or after the intensive care unit (ICU). Aim of this study is to evaluate the NMES effect on physical function of COVID-19 patients.
详细描述
This prospective, randomized, controlled, parallel-group, single-blind trial will include 80 patients who had undergone mechanical or non-invasive ventilation following pneumonia-induced respiratory failure. Patients are randomized to a control group (routine physical therapy for 3 weeks) or a NMES group (routine physical therapy plus NMES of quadriceps and gastrocnemius muscles for 3 weeks). The primary outcome is physical performance assessed through the Short Physical Performance Battery (SPPB). Secondary outcomes include independence level, perceived fatigue, muscle strength, rectus femoris thickness, and walking performance. The SPBB and walking performance will be assessed once (after the 3-week intervention period), while all other outcomes will be assessed twice (before and after the intervention).
NMES is a simple and non-invasive technique for muscle strengthening that is usually well tolerated, does not produce adverse effects, requires no or little cooperation from patients and is quite inexpensive. Therefore, proving the effectiveness of NMES therapy for physical and muscle function in COVID-19 patients could support its systematic incorporation in post-ICU rehabilitation protocols of patients presenting with post-intensive care syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (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
- •age above 18 years
- •respiratory (PaO2/FiO2 ratio > 180 mmHg) and hemodynamic stability for at least two days after withdrawal of mechanical ventilation and neuromuscular blocking agents
排除标准
- •pregnancy
- •known or suspected malignancy in the lower limbs
- •body mass index equal or greater than 35 kg/m2
- •conditions preventing NMES treatment (e.g., deep vein thrombosis, skin lesions, rhabdomyolysis)
- •conditions preventing the outcome assessment (e.g., amputation or inability to transfer independently from bed to chair before hospital admission)
- •presence of an implanted cardiac pacemaker or defibrillator
结局指标
主要结局
Short Physical Performance Battery (SPPB) Score
时间窗: 1 week after the intervention
The SPPB score is a composite measure assessing standing balance (ability to stand for up to 10 seconds with feet positioned in three ways: together side-by-side, semi-tandem and tandem), walking speed (time to complete a 4-m walk), and sit-to- stand performance (time to rise from a chair five times). Each task is scored out of 4 points, with the scores from the three tests summed up to give a total, with a maximum of 12 points and a minimum of 0.
次要结局
- Fatigue Severity Scale Score(Before and 1 week after the intervention)
- Two Step Test Length(1 week after the intervention)
- Six Minutes Walking Test Distance(1 week after the intervention)
- Functional Independence Measure (FIM) Scale Score(Before and 1 week after the intervention)
- Muscle Thickness(Before and 1 week after the intervention)
- Muscle Strength(Before and 1 week after the intervention)
研究者
Marco Alessandro Minetto
Associated Professor
University of Turin, Italy