Effect of Neuromuscular Electrical Stimulation and Early Physical Activity on ICU Acquired Muscle Weakness in Mechanically Ventilated Patient: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Damanhour University
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Assessing a change in limb muscle strength
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Conventional care
Control Group
Exercise Group
Passive/active range of motion exercises group
Intervention: Exercise group (Procedure)
Neuromuscular Electrical Muscle Stimulation group
Neuromuscular Electrical Muscle Stimulation group
Intervention: Neuromuscular Electrical Muscle Stimulation group (Procedure)
Combined therapy (Neuromuscular Electrical Muscle Stimulation pulse limb exercise)
Combined therapy (Neuromuscular Electrical Muscle Stimulation pulse limb exercise).
Intervention: Neuromuscular Electrical Muscle Stimulation and Exercise group (Procedure)
Outcomes
Primary Outcomes
Assessing a change in limb muscle strength
Time Frame: on day 2 of ICU admission, on day 3, and on day 5.
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).
Secondary Outcomes
- Duration of MV(After day 2 of ICU admission and on day 5.)
- ICU length of stay(After day 2 of ICU admission and on day 5.)
- Time to weaning off the ventilator(After day 2 of ICU admission and on day 5.)
Investigators
Sahar Younes
Assistant professor
Damanhour University