Neuromuscular Electrical Stimulation of Lower Limbs in Patients Undergoing Invasive Mechanical Ventilation: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Muscle strength assessed by the Medical Research Council (MRC) sum score at ICU discharge
研究概览
简要总结
This clinical study aims to compare the effects of conventional physical therapy alone versus conventional physical therapy combined with neuromuscular electrical stimulation (NMES) in patients admitted to the ICU and undergoing invasive mechanical ventilation. Participants will be randomly assigned to receive either conventional physical therapy or the same therapy plus NMES applied to the lower limbs. The protocol includes muscle-specific stimulation parameters and safety criteria to postpone sessions in cases of clinical instability. The primary goal is to assess whether NMES improves muscle function and recovery in critically ill patients.
详细描述
This randomized clinical trial will investigate the effects of neuromuscular electrical stimulation (NMES) in critically ill patients undergoing invasive mechanical ventilation. Participants will be randomly assigned to two groups: a control group receiving conventional physical therapy alone and an intervention group receiving conventional physical therapy combined with NMES.
The control group will receive individualized conventional physical therapy, adjusted daily based on each patient's physiological status and following protocols supported by current literature. Interventions may include progressive mobility, such as bed exercises, rolling, sitting at the edge of the bed, standing, chair transfers, and ambulation, as well as respiratory physiotherapy techniques including bronchial hygiene, pulmonary re-expansion, and management of mechanical ventilation. Sessions will last approximately 20 minutes and continue throughout hospitalization, except in cases of clinical contraindications or refusal by the patient/family.
The NMES group will receive the same conventional physical therapy described above, plus NMES applied once or twice daily to both lower limbs for up to 20 consecutive days or until hospital discharge, whichever comes first.
Rectangular electrodes (90 × 50 mm) will be placed bilaterally on the vastus lateralis, vastus medialis, tibialis anterior, hamstrings, and gastrocnemius muscles. If hair interferes with electrode adhesion, the area will be shaved.
NMES will be delivered using the ReCARE® device (Visuri, MG, Brazil) with the following parameters:
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)
盲法说明
The outcomes assessor will be blinded to participant group assignment to minimize bias in outcome evaluation. Participants and care providers will be aware of group assignments.
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
- •Patients will be eligible if they are 18 years or older, are under invasive mechanical ventilation (IMV), and are expected to require IMV for more than 48 hours.
排除标准
- •Body mass index (BMI) greater than or equal to 35 kg/m²;
- •Length of ICU stay longer than 7 ICU-free days or more than 3 continuous days of invasive mechanical ventilation (IMV) before enrollment;
- •Known intracranial process (e.g., stroke, intracranial hypertension);
- •Neuromuscular disease (e.g., Guillain-Barré syndrome, myasthenia gravis) at ICU admission;
- •Inability to speak Portuguese or pre-existing cognitive impairment prior to ICU admission;
- •Any condition that prevents neuromuscular electrical stimulation (NMES) treatment or assessment of the primary outcome in both legs (e.g., skin lesions, fractures, or amputation);
- •Inability to transfer independently from bed to chair before ICU admission;
- •Cardiac arrest as the cause of ICU admission or cardiac arrest before screening;
- •Deep vein thrombosis (DVT) or pulmonary embolism (PE) treated for less than 48 hours;
- •Pregnant patients;
- •Known or suspected malignancy in the legs;
- •Any care limitation including a do-not-resuscitate order.
结局指标
主要结局
Muscle strength assessed by the Medical Research Council (MRC) sum score at ICU discharge
时间窗: Within 24 hours after ICU discharge
Muscle strength will be evaluated by trained physiotherapists using the Medical Research Council (MRC) scale, which grades muscle strength from 0 (no contraction) to 5 (normal strength) in key muscle groups, with a maximum total score of 60 points. Muscle weakness is defined as a score below 48 points. This scale provides a standardized method to evaluate muscular recovery during critical illness and hospitalization.
次要结局
- Rectus femoris muscle thickness measured by ultrasound at initiation of invasive mechanical ventilation(within 24 hours after enrollment)
- Rectus femoris pennation angle measured by ultrasound at initiation of invasive mechanical ventilation(within 24 hours after enrollment)
- Rectus femoris pennation angle measured by ultrasound at sedation awakening(Within 24 hours after awakening from sedation in the ICU)
- Rectus femoris muscle thickness measured by ultrasound at sedation awakening(Within 24 hours after awakening from sedation in the ICU)
- Rectus femoris pennation angle measured by ultrasound at ICU discharge(Within 24 hours after ICU discharge)
- Rectus femoris muscle thickness measured by ultrasound at ICU discharge(Within 24 hours after ICU discharge)
- Rectus femoris pennation angle measured by ultrasound at hospital discharge(From 48 hours to 0 hours before hospital discharge)
- Rectus femoris muscle thickness measured by ultrasound at hospital discharge(From 48 hours to 0 hours before hospital discharge)
- Muscle strength assessed by the Medical Research Council (MRC) sum score at awakening from sedation(Within 24 hours after awakening from sedation in the ICU)
- Muscle strength assessed by the Medical Research Council (MRC) sum score at hospital discharge(From 48 hours to 0 hours before hospital discharge)
- Handgrip strength measured at awakening from sedation in the ICU(Within 24 hours after awakening from sedation in the ICU)
- Handgrip strength measured at ICU discharge(Within 24 hours after ICU discharge)
- Handgrip strength measured at hospital discharge(From 48 hours to 0 hours before hospital discharge)
- Isometric Knee Extension Strength Assessed at Awakening From Sedation in the ICU(Within 24 hours after awakening from sedation in the ICU)
- Isometric Knee Extension Strength Assessed at ICU Discharge(Within 24 hours after ICU discharge)
- Isometric Knee Extension Strength Assessed at Hospital Discharge(From 48 hours to 0 hours before hospital discharge)
- Functional capacity assessed by the Six-Minute Walk Test (6MWT)(From 48 hours to 0 hours before hospital discharge)
- Barthel Index Assessed at Study Enrollment(At baseline (study enrollment))
- Barthel Index Assessed at Hospital Discharge(From 48 hours to 0 hours before hospital discharge)
- Barthel Index Assessed at 6 Months Post Hospital Discharge(6 months after hospital discharge)
- Duration of invasive mechanical ventilation (IMV)(Within 24 hours after ICU discharge)
- Ventilator-free days(Within 24 hours after ICU discharge)
- Length of stay in ICU and hospital(Within 24 hours after hospital discharge)
- Mortality(From hospital admission until death or up to 180 days (6 months) after hospital discharge, whichever occurs first)
研究者
Cassiano Teixeira
Professor Doutor
Hospital Moinhos de Vento