Neuromuscular Electrical Stimulation in Mechanically Ventilated Patients

Sponsor

Damanhour University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05465291

Collaborator

(none)

120

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Neuromuscular Electrical Stimulation ICU Acquired Muscle Weakness	Procedure: Exercise group Procedure: Neuromuscular Electrical Muscle Stimulation group Procedure: Neuromuscular Electrical Muscle Stimulation and Exercise group	N/A

Detailed Description

A prospective randomised 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 on a daily basis. 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 sufficient to detect the effect size of 0.35 according and a power (1-β=0.90) of 90% at a significance probability level alpha of p<0.05 partial eta squared of 0.11. 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 which started with passive limb ROM exercises for nonresponsive patients and will be gradually shifted to active exercises for cooperative patients. 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Sep 15, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Conventional care Control Group
Experimental: Exercise Group Passive/active range of motion exercises group	Procedure: Exercise group This group will receive passive/active range of motion (ROM) exercises which started with passive limb ROM exercises for nonresponsive patients and will be gradually shifted to active exercises for cooperative patients. 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 five days. Other Names: EX Group
Experimental: Neuromuscular Electrical Muscle Stimulation group Neuromuscular Electrical Muscle Stimulation group	Procedure: Neuromuscular Electrical Muscle Stimulation group Patients in NEMS group will receive neuromuscular electrical stimulation from the second day of ICU admission for five 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 five days. Other Names: NEMS group
Experimental: Combined therapy (Neuromuscular Electrical Muscle Stimulation pulse limb exercise) Combined therapy (Neuromuscular Electrical Muscle Stimulation pulse limb exercise).	Procedure: Neuromuscular Electrical Muscle Stimulation and Exercise group Patients in this group will be subjected to Neuromuscular Electrical Muscle Stimulation and Exercise. Other Names: NMES + EX group

Outcome Measures

Primary Outcome Measures

Assessing a change in limb muscle strength [on day 2 of ICU admission, on day 3, and on day 5.]
Limb muscle strength using Medical Research Council score (MRCS). This scale is based on score from 0 (no muscle contraction) to 5 (active movement against complete resistance), six lower and upper limb movements. 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 Outcome Measures

Time to weaning off the ventilator [After day 2 of ICU admission and on day 5.]
Time to weaning off the ventilator
Duration of MV [After day 2 of ICU admission and on day 5.]
Duration of mechanical ventilation
ICU length of stay [After day 2 of ICU admission and on day 5.]
ICU length of stay

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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