Impact of Neuromuscular Electrical Stimulation on Muscle Mass, Strength, and Functionality in Critically Ill Oldest Old Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Skeletal Muscle Mass
研究概览
简要总结
The aim of this clinical trial is to evaluate the effectiveness of Medium-Frequency Neuromuscular Electrical Stimulation, in combination with standard physical therapy, compared to standard physical therapy alone, on muscle mass, muscle strength, and functionality in critically ill patients aged 80 and over during their hospital stay. The safety of the intervention and the standardization of protocol parameters will also be assessed.
The main research questions are:
- Does the implementation of a standardized Medium-Frequency Neuromuscular Electrical Stimulation protocol, in combination with standard physical therapy, compared to standard physical therapy alone, help attenuate the loss of skeletal muscle mass, strength, and functionality in critically ill patients aged 80 and over?
- Is the use of this protocol and its proposed parameters safe for critically ill patients aged 80 and over? The study will consist of applying a standardized Medium-Frequency Neuromuscular Electrical Stimulation protocol to oldest old patients admitted to the Intensive Care Unit of Dr. Hernán Henríquez Aravena Hospital in Temuco, Chile. The sample will consist of oldest old participants (≥80 years), who will be randomly divided into two subgroups: a control group that will receive standard physical therapy typically provided during hospitalization, and an experimental group that will receive the same standard therapy plus Medium-Frequency Neuromuscular Electrical Stimulation, which will begin within the first 48 hours of Intensive Care Unit admission.
The following variables will be assessed in both groups (control and experimental), from Intensive Care Unit admission to hospital discharge:
- Skeletal muscle mass characteristics and evolution (quadriceps femoris and anterior tibialis muscle thickness), measured by ultrasonography.
- Handgrip strength, measured using a digital hand dynamometer.
- Inspiratory muscle strength, assessed using a pimometer.
- Peripheral muscle strength, evaluated with the Medical Research Council Sum Score (MRC-SS).
- Functionality, assessed by the Functional Status Score for the Intensive Care Unit (FSS-ICU) .
- Independence in basic activities of daily living, measured using the Barthel Index.
- Quality of life, evaluated using the Short Form-36 Health Survey (SF-36).
- Cognitive impairment, assessed through the Montreal Cognitive Assessment (MoCA).
- Frailty, measured using the Clinical Frailty Scale (CFS).
详细描述
A clinical trial is proposed to evaluate the effectiveness of Medium-Frequency Neuromuscular Electrical Stimulation, in combination with standard physical therapy, compared to standard physical therapy alone on muscle mass, muscle strength, and functionality in critically ill patients aged 80 and over during their hospital stay. The study will also assess the safety of the intervention and the standardization of the parameters used in the protocol.
General Aim
To evaluate the effectiveness of medium-frequency neuromuscular electrical stimulation, in combination with standard physical therapy, versus standard physical therapy alone, on muscle mass, muscle strength, and functionality in critically ill oldest old patients during their hospital stay.
Specific Objectives
To compare quadriceps femoris muscle thickness (rectus femoris-vastus intermedius) and tibialis anterior muscle thickness via ultrasonography between the study groups during hospitalization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Masking will be single-blind. The data analyst will receive the database with groups coded as A/B and will not have access to the allocation key until the primary analyses are completed.
入排标准
- 年龄范围
- 80 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People aged 80 years or older.
- •Hospitalized in the Adult Critical Care Unit of Dr. Hernán Henríquez Aravena Hospital in Temuco.
- •Estimated mechanical ventilation time greater than 72 hours.
排除标准
- •Patients with prior neurological complications.
- •Patients with severe dependence prior to admission.
- •Patients with difficult-to-manage hemodynamic instability.
- •Patients with accessory elements that limit assessment.
- •Patients with lower limb amputation.
- •Patients in the prone position.
- •Patients with loss of skin integrity.
- •Patients expected to remain in the unit for less than 72 hours.
- •Patients transferred from other services with a stay of more than 72 hours.
研究组 & 干预措施
CONTROL GROUP
Participants of the fourth age (≥80 years old) will receive the standard physical therapy routinely provided during their hospitalization. This intervention involves passive mobilization of the lower limbs, specifically within the ranges of hip flexion, knee flexion and extension, and ankle flexion and extension. One set of 10 bilateral repetitions will be performed while the patient is under sedation in the ICU. Once the patient is awake, the mobilization protocol routinely used in the same unit will be followed.
This intervention will be carried out twice a day: the first session in the morning (08:00-12:00 hrs) and the second in the afternoon (14:00-18:00 hrs). This corresponds to the standard practice in the ICU of Dr. Hernán Henríquez Aravena Hospital.
干预措施: Standard physical therapy (Procedure)
NMES GROUP
The participant will receive standard physical therapy plus medium-frequency NMES.
Two sessions will be carried out-one in the morning (08:00-12:00 hrs) and another in the afternoon (14:00-18:00 hrs)-always following standard physical therapy.
干预措施: Medium Frequency Neuromuscular Electrical Stimulation (NMES) (Device)
NMES GROUP
The participant will receive standard physical therapy plus medium-frequency NMES.
Two sessions will be carried out-one in the morning (08:00-12:00 hrs) and another in the afternoon (14:00-18:00 hrs)-always following standard physical therapy.
干预措施: Standard physical therapy (Procedure)
结局指标
主要结局
Change in Skeletal Muscle Mass
时间窗: ICU admission (baseline): Day 1 During ICU stay (intermediate ICU assessment): average: Day 4-6 Prior to step-down unit discharge (end-of-ICU assessment): average: Day 12-14 Prior to hospital discharge (final assessment): average: Day 18-20
For the assessment of muscle mass, the thickness of the quadriceps muscle-composed of the vastus intermedius and rectus femoris-and the anterior tibialis muscle will be measured using ultrasonography. For quadriceps thickness, the reference point will be the midpoint between the anterior superior iliac spine and the superior pole of the patella. At this point, the following measurements will be taken: vastus intermedius (VI), rectus femoris (RF), and total quadriceps thickness (TQ). For the anterior tibialis muscle, the reference point will be the first third of the distance between the lateral condyle of the tibia and the upper edge of the lateral malleolus. At this reference point, the image will be frozen and the thickness of the anterior tibialis muscle will be measured. For each muscle, three consecutive measurements will be taken, and the average value will be recorded in centimeters.
次要结局
- Change in Handgrip Strength(During ICU stay (intermediate ICU assessment): on average Day 4-6 Prior to step-down unit discharge (end-of-ICU assessment): on average Day 12-14 Prior to hospital discharge (final assessment): on average Day 18-20)
- Change in Peripheral Muscle Strength(During ICU stay (intermediate ICU assessment): on average Day 4-6 Prior to step-down unit discharge (end-of-ICU assessment): on average Day 12-14 Prior to hospital discharge (final assessment): on average Day 18-20)
- Change in Inspiratory Muscle Strength(During ICU stay (intermediate ICU assessment): on average Day 4-6 Prior to step-down unit discharge (end-of-ICU assessment): on average Day 12-14 Prior to hospital discharge (final assessment): on average Day 18-20)
- Change in ICU Functionality(During ICU stay (intermediate ICU assessment): on average Day 4-6 Prior to step-down unit discharge (end-of-ICU assessment): on average Day 12-14)
- Change in Independence in Performing Activities of Daily Living(Prior to step-down unit discharge (end-of-ICU assessment): on average Day 12-14 Prior to hospital discharge (final assessment): on average Day 18-20)
- Change in Perceived Health Status(Prior to step-down unit discharge (end-of-ICU assessment): on average Day 12-14 Prior to hospital discharge (final assessment): on average Day 18-20)
- Change in Frailty(ICU admission (baseline): Day 1 Prior to hospital discharge (final assessment): average: Day 18-20)
- Change in Cognitive Impairment(Prior to step-down unit discharge (end-of-ICU assessment): on average Day 12-14 Prior to hospital discharge (final assessment): on average 18-20)
研究者
Gabriel Nasri Marzuca-Nassr
Associate Professor in the Department of Rehabilitation Sciences, Faculty of Medicine, Universidad de La Frontera, Temuco, Chile.
Universidad de La Frontera