Muscle Mass LossNMES-ECMONCT07566702
Effect of Neuromuscular Electrical Stimulation on Muscle Mass in ECMO Patients
A study testing NMES and Conventional physiothrapy program in people with Muscle Mass Loss, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Mass Loss
- What is being tested?
- NMES and Conventional physiothrapy program
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- May 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
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- Pregnant patients
- Patients receiving intra-aortic balloon pump (IABP) support
- Any contraindication to NMES application
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rana H Elbanna, Assist.Prof contact
Egypt1 site
Faculty of physical therapy
Cairo, Giza, Dokki, 11432
Rana H Elbanna, Assist.Prof, 1062070686 ext. +20
Nesreen G Alnahas, Professor, 1002227242 ext. +20
About this study
Official title: 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
Read the detailed description
- 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).
- Conditions
- Muscle Mass Loss
- Being tested
- NMES, Conventional physiothrapy program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMESDevice
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.
Conventional physiothrapy programBehavioural
Also called Conventional physiotherapy
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: Conventional physiothrapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and after 7 days of intervention
Secondary outcomes (4)
Muscle strength (Medical Research Council Scale - MRC)
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.
Measured: Baseline and after 7 days of intervention
Level of mobility (ICU Mobility Scale - IMS)
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).
Measured: Baseline and after 7 days of intervention
Hospital Length of Stay (LOS)
Length of hospital stay will be measured as the total number of days from ICU admission to hospital discharge.
Measured: From day 1 up to 90 days
Discharge destination
Discharge destination will be assessed using an ordinal scale:
0 = mortality;
- = inpatient hospice;
- = long-term acute care or skilled nursing facility;
- = acute or subacute rehabilitation facility;
- = home with home health services;
- = home without services.
Measured: From day 1 up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study startMay 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Mass LossStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Control group: (25 patients on ECMO) receive conventional PT program. Study group: (25 patients on ECMO) receive NMES plus conventional PT program.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehssan Rabie, Cairo University
- Investigators
- Rana H Elbanna, Assist.Prof, Study director, faculty of physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07566702
- Sponsor's protocol ID
- P.T.REC/012/006074
- Acronym
- NMES-ECMO
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Neuromuscular Electrical Stimulation in Critically Ill Patients Undergoing Extracorporeal Membrane Oxygenation
- ClinicalTrials.gov ID
- NCT07566702
- Acronym / sponsor ID
- NMES-ECMO / P.T.REC/012/006074
- Conditions
- Muscle Mass Loss
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Control group: (25 patients on ECMO) receive conventional PT program. Study group: (25 patients on ECMO) receive NMES plus conventional PT program.
| Arm | Type | Receives |
|---|---|---|
| NMES group | Experimental | Device: NMESIntervention 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). |
| Conventional PT | Active comparator | Behavioral: Conventional physiothrapy programIntervention 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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (9 listed)
- Hemodynamic instability
- Patients requiring ECMO support for less than 72 hours
- Unstable cardiac arrhythmias
- Hemorrhagic shock
- Deep venous thrombosis or pulmonary embolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NMESNMES 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. | Device | NMES group |
| Conventional physiothrapy programAlso: Conventional physiotherapyParticipants 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. | Behavioural | Conventional PT |
Primary outcome
Change in quadriceps muscle mass
Time frame: 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.
4 secondary outcomes
Muscle strength (Medical Research Council Scale - MRC)
Time frame: Baseline and after 7 days of intervention
Level of mobility (ICU Mobility Scale - IMS)
Time frame: Baseline and after 7 days of intervention
Hospital Length of Stay (LOS)
Time frame: From day 1 up to 90 days
Discharge destination
Time frame: From day 1 up to 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rana H Elbanna, Assist.Prof contact
Rana H Elbanna, Assist.Prof study director
faculty of physical therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NMES and Conventional physiothrapy program in people with Muscle Mass Loss, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ehssan R Mahmoud, Master (1096403137 ext. +20, ehssan.rabie.98@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quadriceps muscle mass (time frame: Baseline and after 7 days of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.