Effect of Neuromuscular Electrical Stimulation on Muscle Mass in ECMO Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NMES, Conventional physiothrapy program.
- Who it may be relevant to
- Registry conditions: Muscle Mass Loss. Basic parameters: 20 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effectiveness of Neuromuscular Electrical Stimulation in Critically Ill Patients Undergoing Extracorporeal Membrane Oxygenation
Overview
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
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).
Interventions
- Device 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 - Behavioral 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
Primary outcome measures
- Change in quadriceps muscle mass [Time frame: Baseline and after 7 days of intervention]
Secondary outcome measures (4)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of physical therapy — Cairo
Identifiers
NCT: NCT07566702 · P.T.REC/012/006074