Effect of Neuromuscular Electrical Stimulation and Early Physical Activity on ICU Acquired Muscle Weakness in Mechanically Ventilated Patient: A Randomized Controlled Trial
Sponsor study identifier
interventional
120
1 country
1
Study Start
October 18, 2022
Actual (reported)Primary Completion
February 18, 2023
Actual (reported)Study Completion
February 18, 2023
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 18, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 6, 2022
Actual (reported)July 19, 2022
Actual (reported)October 18, 2022
Actual (reported)February 18, 2023
Actual (reported)February 18, 2023
Actual (reported)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.
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.
Control Group
Passive/active range of motion exercises group
Neuromuscular Electrical Muscle Stimulation 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 .
* 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 .
Faculty of nursing
Damanhur, Beheira, 045/3300376, Egypt
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.
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.
Sahar Y Othman, Assit. Prof.
Faculty of Nursing, Damanhour University
120 participants (actual enrollment reported by the registry).
First Submitted
July 6, 2022
First Posted
July 19, 2022
Study Start
October 18, 2022
Actual (reported)Combined therapy (Neuromuscular Electrical Muscle Stimulation pulse limb exercise).
Patients in this group will be subjected to Neuromuscular Electrical Muscle Stimulation and Exercise.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
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.
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.
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.
Primary Completion
February 18, 2023
Actual (reported)Study Completion
February 18, 2023
Actual (reported)Last Updated
April 11, 2023
Record last verified: 2023-04
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