Neuromuscular Electrical Stimulation in Mechanically Ventilated Patients

April 10, 2023 updated by: Sahar Younes, Damanhour University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Behira
      • Damanhūr, Behira, Egypt, 045/3300376
        • Faculty of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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. 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 .
Other Names:
  • EX Group
Experimental: Neuromuscular Electrical Muscle Stimulation group
Procedure: Neuromuscular Electrical Muscle Stimulation group
  • 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 .
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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 Frame: 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.
Duration of MV
Time Frame: After day 2 of ICU admission and on day 5.
Duration of mechanical ventilation
After day 2 of ICU admission and on day 5.
ICU length of stay
Time Frame: After day 2 of ICU admission and on day 5.
ICU length of stay
After day 2 of ICU admission and on day 5.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damanhour University

Investigators

  • Principal Investigator: Sahar Y Othman, Assit. Prof., Faculty of Nursing, Damanhour University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2022

Primary Completion (Actual)

February 18, 2023

Study Completion (Actual)

February 18, 2023

Study Registration Dates

First Submitted

July 6, 2022

First Submitted That Met QC Criteria

July 16, 2022

First Posted (Actual)

July 19, 2022

Study Record Updates

Last Update Posted (Actual)

April 11, 2023

Last Update Submitted That Met QC Criteria

April 10, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Neuromuscular stimulation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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