Effect of Neuromuscular Electrical Stimulation on Muscle Mass in ECMO Patients (NMES-ECMO)
Effectiveness of Neuromuscular Electrical Stimulation in Critically Ill Patients Undergoing Extracorporeal Membrane Oxygenation
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
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
- Design of the study:
In this study the patients will be randomly assigned into two equal groups (25 patients for each group):
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).
- 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).
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Ehssan R Mahmoud, Master
- Numer telefonu: +20 1096403137
- E-mail: ehssan.rabie.98@gmail.com
Kopia zapasowa kontaktu do badania
- Nazwa: Rana H Elbanna, Assist.Prof
- Numer telefonu: +20 1062070686
Lokalizacje studiów
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Giza, Dokki
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Cairo, Giza, Dokki, Egipt, 11432
- Faculty of Physical Therapy
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Kontakt:
- Rana H Elbanna, Assist.Prof
- Numer telefonu: +20 1062070686
-
Kontakt:
- Nesreen G Alnahas, Professor
- Numer telefonu: +20 1002227242
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Hemodynamic instability
- Patients requiring ECMO support for less than 72 hours
- Unstable cardiac arrhythmias
- Hemorrhagic shock
- Deep venous thrombosis or pulmonary embolism
- Lower limb open wounds or acute skin burns at electrode placement sites
- Pregnant patients
- Patients receiving intra-aortic balloon pump (IABP) support
- Any contraindication to NMES application
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: NMES group
Intervention Name: Neuromuscular Electrical Stimulation (NMES) + Conventional Physiotherapy Intervention Type: Other Intervention Description: Patients will receive neuromuscular electrical stimulation (NMES) in addition to a conventional physiotherapy program while undergoing ECMO. NMES will be applied bilaterally to the quadriceps femoris muscles using a VMS current 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 a supine position with slight knee flexion (approximately 40 degrees). In addition, they will receive a conventional physiotherapy program twice daily(passive and active-assisted range of motion exercises, bed mobility, sitting, standing, and ambulation). |
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 addition, participants will receive a conventional physiotherapy program twice daily, including passive and active-assisted range of motion exercises, early mobilization, bed mobility, sitting, standing, and ambulation. |
|
Aktywny komparator: Conventional PT
Intervention Name: Conventional Physiotherapy Program Intervention Type: Other Intervention Description: Participants will receive a conventional physiotherapy program only, administered twice daily for one week during ECMO support. The program will include early mobilization starting with passive movements and progressing to active-assisted and active exercises as tolerated. Rehabilitation activities will include in-bed mobility, sitting at the edge of the bed, standing, and assisted ambulation based on patient condition and tolerance. No neuromuscular electrical stimulation will be applied in this group. |
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 ambulation according to patient tolerance and clinical stability. All interventions will be delivered according to standard ICU physiotherapy practices. Neuromuscular electrical stimulation (NMES) will not be applied in this group.
Inne nazwy:
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in quadriceps muscle mass
Ramy czasowe: Baseline and after 7 days of intervention
|
Quadriceps muscle mass will be assessed using ultrasonography by measuring muscle thickness and/or cross-sectional area of the rectus femoris muscle.
Measurements will be performed at baseline (before intervention) and after one week of intervention during ECMO support.
The primary endpoint will be the change in muscle mass over time between groups.
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Baseline and after 7 days of intervention
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Muscle strength (Medical Research Council Scale - MRC)
Ramy czasowe: Baseline and after 7 days of intervention
|
Muscle strength will be assessed using the Medical Research Council (MRC) scale for major muscle groups.
The total MRC score will be recorded to evaluate global muscle strength.
|
Baseline and after 7 days of intervention
|
|
Level of mobility (ICU Mobility Scale - IMS)
Ramy czasowe: Baseline and after 7 days of intervention
|
Functional mobility will be assessed using the ICU Mobility Scale (IMS), an 11-point ordinal scale ranging from 0 (lying in bed) to 10 (independent ambulation).
|
Baseline and after 7 days of intervention
|
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Hospital Length of Stay (LOS)
Ramy czasowe: From day 1 up to 90 days
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Length of hospital stay will be measured as the total number of days from ICU admission to hospital discharge.
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From day 1 up to 90 days
|
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Discharge destination
Ramy czasowe: From day 1 up to 90 days
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Discharge destination will be assessed using an ordinal scale: 0 = mortality;
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From day 1 up to 90 days
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Współpracownicy i badacze
Sponsor
Śledczy
- Dyrektor Studium: Rana H Elbanna, Assist.Prof, Faculty of Physical Therapy
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- P.T.REC/012/006074
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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