Effects of Low- and Medium-frequency Neuromuscular Electrical Stimulation on Skeletal Muscle Atrophy in Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Change in thickness of the quadriceps muscle, evaluated with ultrasonography while patients were in intensive critical unit (ICU).
研究概览
简要总结
Background: Low-frequency neuromuscular electrical stimulation (NMES) attenuates the loss of muscle mass of Intensive Care Unit (ICU) patients. However, it has been shown that medium-frequency NMES may be better than low-frequency for the maintenance of skeletal muscle mass in healthy subjects.
Objective: to compare the effects of low-frequency and medium-frequency NMES, along with a standard physical therapy (SPT) programme, on the attenuation of skeletal muscle atrophy in critically ill patients.
Methods: Fifty-four critically ill patients admitted into intensive care unit (ICU) and on mechanical ventilation (MV) participated in this randomized, single-blinded, experimental study. Participants were allocated to one of the following groups: Control Group (CG), received a standard lower limb physical therapy (SPT) programme, 2x/day; Low-frequency NMES Group (LFG), received lower limb SPT+NMES at 100 Hz, 2x/day; and Medium-frequency NMES Group (MFG), received lower limb SPT+NMES at 100 Hz and carrier frequency of 2500 Hz, 2x/day. The primary outcome was the thickness and quality of the quadriceps muscle, evaluated with ultrasonography while patients were in ICU. Secondary outcomes, assessed at various stages of recovery, were strength, functionality, independence for activities of daily living, quality of life, and total days hospitalized.
详细描述
Background: Low-frequency neuromuscular electrical stimulation (NMES) attenuates the loss of muscle mass of Intensive Care Unit (ICU) patients. However, it has been shown that medium-frequency NMES may be better than low-frequency for the maintenance of skeletal muscle mass in healthy subjects.
Research question: The research question was is medium-frequency neuromuscular electrical stimulation (NMES) more effective than low-frequency NMES for the attenuation of skeletal muscle atrophy in critically ill patients?
Objective
To compare the effects of low-frequency and medium-frequency NMES, along with a standard physical therapy (SPT) programme, on the attenuation of skeletal muscle atrophy in critically ill patients.
Methods: Fifty-four critically ill patients admitted into intensive care unit (ICU) and on mechanical ventilation (MV) participated in this randomized, single-blinded, experimental study. Participants were allocated to one of the following groups: Control Group (CG), received a standard lower limb physical therapy (SPT) programme, 2x/day; Low-frequency NMES Group (LFG), received lower limb SPT+NMES at 100 Hz, 2x/day; and Medium-frequency NMES Group (MFG), received lower limb SPT+NMES at 100 Hz and carrier frequency of 2500 Hz, 2x/day. The primary outcome was the thickness and quality of the quadriceps muscle, evaluated with ultrasonography while patients were in ICU. Secondary outcomes, assessed at various stages of recovery, were muscle strength (MRC-SS), handgrip strength (dynamometry), functional status (FSS-ICU), degree of independence for activities of daily living (Barthel Index), functional mobility and dynamic balance (Timed Up and Go Test), quality of life (SF-36), and total days hospitalized.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients between 18-80 years old admitted in ICU with requirement of mechanical ventilation (MV) for longer than 72 h.
排除标准
- •non-sedated patients;
- •spinal cord injury;
- •cerebrovascular accident;
- •patients with pacemakers;
- •history of deep vein thrombosis;
- •pregnancy;
- •cardiac complications (history of myocardial infarction or congenital diseases);
- •use of neuromuscular blockers;
- •polytraumatized patients requiring tutor support.
结局指标
主要结局
Change in thickness of the quadriceps muscle, evaluated with ultrasonography while patients were in intensive critical unit (ICU).
时间窗: Day 1, Day 5, Day 9
Thickness of the quadriceps muscle via ultrasonography (mm).
Change in quality of the quadriceps muscle, evaluated with ultrasonography while patients were in intensive critical unit (ICU).
时间窗: Day 1, Day 5, Day 9
Quality of the quadriceps muscle via ultrasonography by Heckmatt's rating scale. Muscle quality was estimated by Heckmatt's rating scale, which scores the ultrasound images between 1-4: 1) normal echogenicity; 2) slight increase in muscle echogenicity and normal bone reflection; 3) moderate increase in muscle echogenicity and reduced bone reflection; 4) large increase in muscle echogenicity and no bone reflection.
次要结局
- Change in Handgrip strength while patients were in hospital stay.(Day 9, Day 11, Day 16, and Day 27)
- Change in independence for activities of daily living while patients were in hospital stay.(Day 16, and Day 27)
- Change in Clinical assessment of muscle strength while patients were in intensive care unit (ICU).(Day 9, Day 11, Day 16, and Day 27)
- Change in Functional status while patients were in Intensive Care unit (ICU).(Day 9, Day 11, Day 16, and Day 27)
- Change in dynamic balance while patients were in hospital stay.(Day 16, and Day 27)
- Change in quality of life prior to hospital discharge.(Day 27)
研究者
Gabriel Nasri Marzuca-Nassr
Professor
Universidad de La Frontera