Набор скоро начнётся NCT07566702

Effect of Neuromuscular Electrical Stimulation on Muscle Mass in ECMO Patients

Без фазы С лечением Muscle Mass Loss

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: NMES, Conventional physiothrapy program.
Кому может быть актуально: Состояния в реестре: Muscle Mass Loss. Базовые параметры: 20 лет — 50 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Египет
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Effectiveness of Neuromuscular Electrical Stimulation in Critically Ill Patients Undergoing Extracorporeal Membrane Oxygenation

Обзор

The goal of this clinical trial study: is to determine the effectiveness of neuromuscular electrical stimulation in critically ill patients undergoing extracorporeal membrane oxygenation. The main questions it aims to answer are: * Does NMES has an effect when added to conventional protocol for ECMO patients? * Does NMES will help in preserve muscle mass? * Patients will recieve the treatment untill discharge. * Assesment will be done before and after treatement

Подробное описание

1. Subjects:

Fifty Patients from both genders with pulmonary or cardiac disease receiving extracorporeal membrane oxygenation will participate in this study. They will randomly have divided into two groups equal in numb.Their ages will be ranged from 20 to 50 years. 2. Design of the study:

In this study the patients will be randomly assigned into two equal groups (25 patients for each group):

1. Group A (Study group):

This group includes 25 patients who will receive VMS current of NMES on quadriceps muscle bilateral for 30 min daily for one week in addition to conventional physiotherapy program (Range of motion exercises, Positioning,Strengthening exercises and Stretching exercises). 2. Group B (Control group):

This group will include 25 patients. The participants will receive conventional physiotherapy program (Range of motion exercises, Positioning,Strengthening exercises and Stretching exercises) two times per day for one week.

\- Equipments:

Measurement equipments:

A-Evaluating muscle strength The Medical Research Council (MRC) Scale for Muscle Strength B-Evaluating muscle mass Ultrasonography for assessing quadriceps muscle mass applied by ACUSON P500 manufactured by SEIMENS made in USA C-Evaluating level of activity ICU Mobility scale (IMS): IMS provides a sensitive 11-point ordinal scale, ranging from nothing (lying/passive exercises in bed, score of 0) to independent ambulation (score of 10).

D- Hospital length of stay (LOS) days E-Discharge destination Discharge destination was ranked on an ordinal scale: 0 = mortality; 1 = discharge to inpatient hospice; 2 = discharge to long-term acute care facility equivalent to ventilator weaning and skilled nursing facilities; 3 = discharge to acute and subacute care rehabilitation facilities; 4 = discharge to home with home health rehabilitation services; and 5 = discharge to home with no services.

F- Incidence and type of ECMO complication

\- Treatmenet Procedures: NMES will be applied by using DJO/ Chattanooga - USA 2023 Patients on ECMO will receive daily 30-minute of neuromuscular electrical stimulation VMS current / on the quadriceps femoris muscles (rectus femoris and vastus intermedius) bilaterally as long as they were on ECMO to preserve muscle mass. Patients will be supine lying with knee slight flexion 40 degree by billow. 2 rectangular carbon electrodes (6×8 cm) on the muscle motor point, Frequency 50 pps , with a 1000 usec phase duration, ramp 5 sec, duty cycle 1:5.

The conventional program for both groups:

(Early mobilization started passively and progressed to be active, and progressed from in bed mobility to out of bed mobility, Mobilization activities, Passive- and active-assisted movements of extremities, Sitting on a chair, Bedside standing, Walking with support).

Вмешательства

Устройство NMES
NMES will be applied bilaterally to the quadriceps femoris muscles (rectus femoris and vastus intermedius) for 30 minutes daily for one week. Stimulation parameters will include a frequency of 50 pulses per second, pulse duration of 1000 microseconds, ramp time of 5 seconds, and a duty cycle of 1:5. Two rectangular carbon electrodes (6 × 8 cm) will be placed over the motor points of the targeted muscles. Patients will be positioned in supine lying with approximately 40 degrees knee flexion. In
Поведенческое Conventional physiothrapy program
Participants in this group will receive a conventional physiotherapy program only during extracorporeal membrane oxygenation (ECMO) support. The program will be administered twice daily for one week. The intervention will include early mobilization strategies starting with passive range of motion exercises and progressing to active-assisted and active exercises as tolerated. Rehabilitation activities will include bed mobility, sitting at the edge of the bed, bedside standing, and assisted ambul

Первичные конечные точки

Change in quadriceps muscle mass [Срок оценки: Baseline and after 7 days of intervention]

Вторичные конечные точки (4)

Muscle strength (Medical Research Council Scale - MRC) [Срок оценки: Baseline and after 7 days of intervention]
Level of mobility (ICU Mobility Scale - IMS) [Срок оценки: Baseline and after 7 days of intervention]
Hospital Length of Stay (LOS) [Срок оценки: From day 1 up to 90 days]
Discharge destination [Срок оценки: From day 1 up to 90 days]

Критерии участия

Критерии включения

Adult patients of both sexes aged 20 to 50 years
Patients receiving extracorporeal membrane oxygenation (ECMO) (veno-venous or veno- arterial)
Patients admitted to the ECMO unit for at least 72 hours
Hemodynamically stable patients as determined by the treating medical team
Patients medically eligible for participation in physiotherapy and neuromuscular electrical stimulation (NMES)