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Neuromuscular Electrical Stimulation in Mechanically Ventilated Patients

Primary Purpose

Neuromuscular Electrical Stimulation, ICU Acquired Muscle Weakness

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Exercise group
Neuromuscular Electrical Muscle Stimulation group
Neuromuscular Electrical Muscle Stimulation and Exercise group
Sponsored by
Damanhour University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Neuromuscular Electrical Stimulation focused on measuring Mechanical ventilation, Rehabilitation, Critical care, Physiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Faculty of nursing

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Conventional care

Exercise Group

Neuromuscular Electrical Muscle Stimulation group

Combined therapy (Neuromuscular Electrical Muscle Stimulation pulse limb exercise)

Arm Description

Control Group

Passive/active range of motion exercises group

Neuromuscular Electrical Muscle Stimulation group

Combined therapy (Neuromuscular Electrical Muscle Stimulation pulse limb exercise).

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Time to weaning off the ventilator
Time to weaning off the ventilator
Duration of MV
Duration of mechanical ventilation
ICU length of stay
ICU length of stay

Full Information

First Posted
July 6, 2022
Last Updated
April 10, 2023
Sponsor
Damanhour University
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1. Study Identification

Unique Protocol Identification Number
NCT05465291
Brief Title
Neuromuscular Electrical Stimulation in Mechanically Ventilated Patients
Official Title
Effect of Neuromuscular Electrical Stimulation and Early Physical Activity on ICU Acquired Muscle Weakness in Mechanically Ventilated Patient: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
October 18, 2022 (Actual)
Primary Completion Date
February 18, 2023 (Actual)
Study Completion Date
February 18, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Damanhour University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromuscular Electrical Stimulation, ICU Acquired Muscle Weakness
Keywords
Mechanical ventilation, Rehabilitation, Critical care, Physiotherapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional care
Arm Type
No Intervention
Arm Description
Control Group
Arm Title
Exercise Group
Arm Type
Experimental
Arm Description
Passive/active range of motion exercises group
Arm Title
Neuromuscular Electrical Muscle Stimulation group
Arm Type
Experimental
Arm Description
Neuromuscular Electrical Muscle Stimulation group
Arm Title
Combined therapy (Neuromuscular Electrical Muscle Stimulation pulse limb exercise)
Arm Type
Experimental
Arm Description
Combined therapy (Neuromuscular Electrical Muscle Stimulation pulse limb exercise).
Intervention Type
Procedure
Intervention Name(s)
Exercise group
Other Intervention Name(s)
EX Group
Intervention Description
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 .
Intervention Type
Procedure
Intervention Name(s)
Neuromuscular Electrical Muscle Stimulation group
Other Intervention Name(s)
NEMS group
Intervention Description
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 .
Intervention Type
Procedure
Intervention Name(s)
Neuromuscular Electrical Muscle Stimulation and Exercise group
Other Intervention Name(s)
NMES + EX group
Intervention Description
Patients in this group will be subjected to Neuromuscular Electrical Muscle Stimulation and Exercise.
Primary Outcome Measure Information:
Title
Assessing a change in limb muscle strength
Description
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).
Time Frame
on day 2 of ICU admission, on day 3, and on day 5.
Secondary Outcome Measure Information:
Title
Time to weaning off the ventilator
Description
Time to weaning off the ventilator
Time Frame
After day 2 of ICU admission and on day 5.
Title
Duration of MV
Description
Duration of mechanical ventilation
Time Frame
After day 2 of ICU admission and on day 5.
Title
ICU length of stay
Description
ICU length of stay
Time Frame
After day 2 of ICU admission and on day 5.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sahar Y Othman, Assit. Prof.
Organizational Affiliation
Faculty of Nursing, Damanhour University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of nursing
City
Damanhūr
State/Province
Behira
ZIP/Postal Code
045/3300376
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35428629
Citation
Cusack R, Bates A, Mitchell K, van Willigen Z, Denehy L, Hart N, Dushianthan A, Reading I, Chorozoglou M, Sturmey G, Davey I, Grocott M. Improving physical function of patients following intensive care unit admission (EMPRESS): protocol of a randomised controlled feasibility trial. BMJ Open. 2022 Apr 15;12(4):e055285. doi: 10.1136/bmjopen-2021-055285.
Results Reference
background
PubMed Identifier
25316527
Citation
McWilliams D, Weblin J, Atkins G, Bion J, Williams J, Elliott C, Whitehouse T, Snelson C. Enhancing rehabilitation of mechanically ventilated patients in the intensive care unit: a quality improvement project. J Crit Care. 2015 Feb;30(1):13-8. doi: 10.1016/j.jcrc.2014.09.018. Epub 2014 Oct 2.
Results Reference
background
PubMed Identifier
34971331
Citation
Cerqueira TCF, de Cerqueira Neto ML, Cacau LAP, de Araujo Filho AA, Oliveira GU, da Silva Junior WM, Carvalho VO, de Mendonca JT, de Santana Filho VJ. Effect of neuromuscular electrical stimulation on functional exercise capacity in patients undergoing cardiac surgery: A randomized clinical trial. Clin Rehabil. 2022 Jun;36(6):789-800. doi: 10.1177/02692155211070945. Epub 2021 Dec 31.
Results Reference
background
PubMed Identifier
26784735
Citation
Gomes Neto M, Oliveira FA, Reis HF, de Sousa Rodrigues- E Jr, Bittencourt HS, Oliveira Carvalho V. Effects of Neuromuscular Electrical Stimulation on Physiologic and Functional Measurements in Patients With Heart Failure: A SYSTEMATIC REVIEW WITH META-ANALYSIS. J Cardiopulm Rehabil Prev. 2016 May-Jun;36(3):157-66. doi: 10.1097/HCR.0000000000000151.
Results Reference
background
PubMed Identifier
33080746
Citation
Sumin AN, Oleinik PA, Bezdenezhnykh AV, Ivanova AV. Neuromuscular electrical stimulation in early rehabilitation of patients with postoperative complications after cardiovascular surgery: A randomized controlled trial. Medicine (Baltimore). 2020 Oct 16;99(42):e22769. doi: 10.1097/MD.0000000000022769.
Results Reference
background
PubMed Identifier
33634830
Citation
Burgess LC, Venugopalan L, Badger J, Street T, Alon G, Jarvis JC, Wainwright TW, Everington T, Taylor P, Swain ID. Effect of neuromuscular electrical stimulation on the recovery of people with COVID-19 admitted to the intensive care unit: A narrative review. J Rehabil Med. 2021 Mar 18;53(3):jrm00164. doi: 10.2340/16501977-2805.
Results Reference
result

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Neuromuscular Electrical Stimulation in Mechanically Ventilated Patients

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