Effect of Neuromuscular Electrical Stimulation on Muscle Mass in ECMO Patients

NCT07566702 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/006074
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Muscle Mass Loss

Outcome Measures

Primary Outcomes (1)

• Change in quadriceps muscle mass

  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.

  Baseline and after 7 days of intervention

Secondary Outcomes (4)

• Muscle strength (Medical Research Council Scale - MRC)

  Baseline and after 7 days of intervention

• Level of mobility (ICU Mobility Scale - IMS)

  Baseline and after 7 days of intervention

• Hospital Length of Stay (LOS)

  From day 1 up to 90 days

• Discharge destination

  From day 1 up to 90 days

Study Arms (2)

NMES group

EXPERIMENTAL

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).

Device: NMES

Conventional PT

ACTIVE COMPARATOR

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.

Behavioral: Conventional physiothrapy program

Interventions

NMES DEVICE

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.

NMES group

Conventional physiothrapy program BEHAVIORAL

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.

Also known as: Conventional physiotherapy

Conventional PT

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of physical therapy

Cairo, Giza, Dokki, 11432, Egypt

Location

Study Officials

• Rana H Elbanna, Assist.Prof

  faculty of physical therapy

  STUDY DIRECTOR

Central Study Contacts

Ehssan R Mahmoud, Master

CONTACT

1096403137; ehssan.rabie.98@gmail.com

Rana H Elbanna, Assist.Prof

CONTACT

1062070686

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapy specialist

Model Details: Control group: (25 patients on ECMO) receive conventional PT program. Study group: (25 patients on ECMO) receive NMES plus conventional PT program.

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: May 5, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)