Neuromuscular Electrical Stimulation in Mechanically Ventilated Patients

Study Overview
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Brief Summary
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Intensive care unit-acquired muscle weakness (ICUAMW) is a common problem following an ICU admission and is associated with prolonged hospitalization, delayed weaning and increased mortality. Up to 25% of patients requiring mechanical ventilation (MV) for greater than 7 days develop ICUAW, and this figure may rise to 50-100% in the septic population. Long-term follow-up studies of survivors of critical illness have demonstrated significantly impaired health-related quality of life and physical functioning up to 5 years after ICU discharge, with weakness being the most commonly reported physical limitation. Early rehabilitation has been shown to be safe and feasible; however, commencement is often delayed due to a patient's inability to cooperate. An intervention that begins early in ICU admission without the need for patient volition may be beneficial in attenuating muscle wasting. Therefore, this study aims to evaluate the effect of neuromuscular electrical stimulation and early physical activity on ICU acquired muscle weakness in mechanically ventilated patient

Detailed Description
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A randomized controlled study will be carried out to achieve the aim of the current study. For three months, from July 15, 2022 to September 15, 2022, newly admitted patients will be screened. Patients in this trial will be recruited prospectively within 24 hours of admission to the general ICU. Computer-generated randomization will be used to assign patients to one of four groups: neuromuscular electrical stimulation (NMES), exercise (EX); combined therapy (NMES + EX); or conventional care (control group). A minimum total sample size of 120 samples will be included. According to sample size calculations treatment groups (NMES, EX, NMES + EX or conventional care) would be represented by a minimum of 30 patients. A total sample size a 120 will be selected for the study. All patients in the four groups will receive ICU standard care which includes sedation and weaning protocols. Conventional care (Control Group): Patients in this group will receive usual physiotherapy consisting of in-bed EXs and ICU standard care. Exercise group (EX Group): This group will receive passive/active exercise range of motion (ROM) exercises . ROM exercises will include major muscle groups (i.e. biceps, triceps, and lower limbs) and will be applied the second day of 1CU admission for seven days. Neuromuscular Electrical Muscle Stimulation (NEMS Group): Patients in NEMS group will receive neuromuscular electrical stimulation from the second day of ICU admission for seven days. Neuromuscular electrical stimulation will be implemented simultaneously on the rectus femoris, vastus lateralis, and vastus medialis muscles of both lower limbs, with two stimulators, in two 30-min sessions per day starting from the second day after admission for seven days. Combined therapy (NMES + EX): Patients in this group will be subjected to NMES pulse EX. The application of NMES occurring simultaneously to the upper and lower limbs exercises. The ICU acquired muscle weakness assessment tool will be developed by the researchers to assess and record occurrence of ICUAMW.

Official Title
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Effect of Neuromuscular Electrical Stimulation and Early Physical Activity on ICU Acquired Muscle Weakness in Mechanically Ventilated Patient: A Randomized Controlled Trial

Conditions
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Neuromuscular Electrical Stimulation, ICU Acquired Muscle Weakness

Intervention / Treatment
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* Procedure: Exercise group
* Procedure: Neuromuscular Electrical Muscle Stimulation group
* Procedure: Neuromuscular Electrical Muscle Stimulation and Exercise group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged ≥18 years, mechanically ventilated for ≥48 h remain in the intensive care ≥4 days. Exclusion Criteria: Pre-existing neuromuscular disease brain death peripheral vascular diseases (arterial lower limb disease and deep venous thrombosis) hemiplegia/quadriplegia lower limb amputation spinal injuries receiving muscle relaxant; cognitive impairment; body mass index (BMI) > 35 kg/m2; bone fractures skin lesions presence of cardiac pacemaker end-stage cancer

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conventional care<br>Control Group | |
| Experimental: Exercise Group<br>Passive/active range of motion exercises group | Procedure: Exercise group<br>* This group will receive passive/active range of motion (ROM) exercises. ROM exercises will include major muscle groups (i.e. biceps, triceps, and lower limbs) and will be applied from second day till seventh day of admission .<br>* Other names: EX Group;|
| Experimental: Neuromuscular Electrical Muscle Stimulation group<br>Neuromuscular Electrical Muscle Stimulation group | Procedure: Neuromuscular Electrical Muscle Stimulation group<br>* Patients in NEMS group will receive neuromuscular electrical stimulation from second day till seventh day of admission. Neuromuscular electrical stimulation will be implemented simultaneously on the rectus femoris, vastus lateralis, and vastus medialis muscles of both lower limbs, with two stimulators, in two 30-min sessions per day starting from the second day till seventh day of admission .<br>* Other names: NEMS group;|
| Experimental: Combined therapy (Neuromuscular Electrical Muscle Stimulation pulse limb exercise)<br>Combined therapy (Neuromuscular Electrical Muscle Stimulation pulse limb exercise). | Procedure: Neuromuscular Electrical Muscle Stimulation and Exercise group<br>* Patients in this group will be subjected to Neuromuscular Electrical Muscle Stimulation and Exercise.<br>* Other names: NMES + EX group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing a change in limb muscle strength | Limb muscle strength using Medical Research Council score (MRCS). Three muscle groups in all four limbs will be assessed with the MRC scale with values ranging from 0 (quadriplegia….severe muscle weakness) to 60 (normal muscle strength). | on day 2 of ICU admission, on day 3, and on day 5. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to weaning off the ventilator | Time to weaning off the ventilator | After day 2 of ICU admission and on day 5. | 
| Duration of MV | Duration of mechanical ventilation | After day 2 of ICU admission and on day 5. | 
| ICU length of stay | ICU length of stay | After day 2 of ICU admission and on day 5. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mechanical ventilation, Rehabilitation, Critical care, Physiotherapy