Neuromuscular Electrical Stimulation in Mechanically Ventilated Patients

NCT05465291 | Completed

• 1 other identifier: Neuromuscular stimulation
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Neuromuscular Electrical Stimulation; ICU Acquired Muscle Weakness

Keywords

Mechanical ventilation; Rehabilitation; Critical care; Physiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Time to weaning off the ventilator

  After day 2 of ICU admission and on day 5.

• 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.

Study Arms (4)

Conventional care

NO INTERVENTION

Control Group

Exercise Group

EXPERIMENTAL

Passive/active range of motion exercises group

Procedure: Exercise group

Neuromuscular Electrical Muscle Stimulation group

EXPERIMENTAL

Neuromuscular Electrical Muscle Stimulation group

Procedure: Neuromuscular Electrical Muscle Stimulation group

Combined therapy (Neuromuscular Electrical Muscle Stimulation pulse limb exercise)

EXPERIMENTAL

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

Procedure: Neuromuscular Electrical Muscle Stimulation and Exercise group

Interventions

Exercise group PROCEDURE

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 .

Also known as: EX Group

Exercise Group

Neuromuscular Electrical Muscle Stimulation group PROCEDURE

* 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 .

Also known as: NEMS group

Neuromuscular Electrical Muscle Stimulation group

Neuromuscular Electrical Muscle Stimulation and Exercise group PROCEDURE

Patients in this group will be subjected to Neuromuscular Electrical Muscle Stimulation and Exercise.

Also known as: NMES + EX group

Combined therapy (Neuromuscular Electrical Muscle Stimulation pulse limb exercise)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged ≥18 years,
• mechanically ventilated for ≥48 h
• remain in the intensive care ≥4 days.

You may not qualify if:

• 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

Sponsors & Collaborators

• Damanhour University: lead

Study Sites (1)

Faculty of nursing

Damanhūr, Behira, 045/3300376, Egypt

Location

Related Publications (6)

• 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.

  PMID: 35428629 BACKGROUND

• 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.

  PMID: 25316527 BACKGROUND

• 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.

  PMID: 34971331 BACKGROUND

• 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.

  PMID: 26784735 BACKGROUND

• 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.

  PMID: 33080746 BACKGROUND

• 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.

  PMID: 33634830 RESULT

Study Officials

• Sahar Y Othman, Assit. Prof.

  Faculty of Nursing, Damanhour University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 19, 2022
• Study Start: October 18, 2022
• Primary Completion: February 18, 2023
• Study Completion: February 18, 2023
• Last Updated: April 11, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)