Neuromuscular Electrical Stimulation (NMES) Preserves Muscle Mass in Intensive Care Unit (ICU)
Effects of Low- and Medium-frequency Neuromuscular Electrical Stimulation on Skeletal Muscle Atrophy in Critically Ill Patients
1 other identifier
interventional
54
1 country
1
Brief Summary
Background: Low-frequency neuromuscular electrical stimulation (NMES) attenuates the loss of muscle mass of Intensive Care Unit (ICU) patients. However, it has been shown that medium-frequency NMES may be better than low-frequency for the maintenance of skeletal muscle mass in healthy subjects. Objective: to compare the effects of low-frequency and medium-frequency NMES, along with a standard physical therapy (SPT) programme, on the attenuation of skeletal muscle atrophy in critically ill patients. Methods: Fifty-four critically ill patients admitted into intensive care unit (ICU) and on mechanical ventilation (MV) participated in this randomized, single-blinded, experimental study. Participants were allocated to one of the following groups: Control Group (CG), received a standard lower limb physical therapy (SPT) programme, 2x/day; Low-frequency NMES Group (LFG), received lower limb SPT+NMES at 100 Hz, 2x/day; and Medium-frequency NMES Group (MFG), received lower limb SPT+NMES at 100 Hz and carrier frequency of 2500 Hz, 2x/day. The primary outcome was the thickness and quality of the quadriceps muscle, evaluated with ultrasonography while patients were in ICU. Secondary outcomes, assessed at various stages of recovery, were strength, functionality, independence for activities of daily living, quality of life, and total days hospitalized.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2020
CompletedFirst Submitted
Initial submission to the registry
February 19, 2022
CompletedFirst Posted
Study publicly available on registry
March 18, 2022
CompletedMarch 18, 2022
March 1, 2022
6 months
February 19, 2022
March 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in thickness of the quadriceps muscle, evaluated with ultrasonography while patients were in intensive critical unit (ICU).
Thickness of the quadriceps muscle via ultrasonography (mm).
Day 1, Day 5, Day 9
Change in quality of the quadriceps muscle, evaluated with ultrasonography while patients were in intensive critical unit (ICU).
Quality of the quadriceps muscle via ultrasonography by Heckmatt's rating scale. Muscle quality was estimated by Heckmatt's rating scale, which scores the ultrasound images between 1-4: 1) normal echogenicity; 2) slight increase in muscle echogenicity and normal bone reflection; 3) moderate increase in muscle echogenicity and reduced bone reflection; 4) large increase in muscle echogenicity and no bone reflection.
Day 1, Day 5, Day 9
Secondary Outcomes (6)
Change in Clinical assessment of muscle strength while patients were in intensive care unit (ICU).
Day 9, Day 11, Day 16, and Day 27
Change in Handgrip strength while patients were in hospital stay.
Day 9, Day 11, Day 16, and Day 27
Change in Functional status while patients were in Intensive Care unit (ICU).
Day 9, Day 11, Day 16, and Day 27
Change in dynamic balance while patients were in hospital stay.
Day 16, and Day 27
Change in independence for activities of daily living while patients were in hospital stay.
Day 16, and Day 27
- +1 more secondary outcomes
Other Outcomes (3)
Change in days spent in Mechanical Ventilation.
Through mechanical ventilation use completion, an average of 9 days
Change in days spent in Intensive Care Unit.
Through Intensive Care Unit stay completion, an average of 11 days
Change in days spent in the hospital.
Through hospital stay completion, an average of 27 days
Study Arms (3)
Control group
OTHERPatients received the standard physical therapy (SPT) programme only (passive mobilization) twice a day.
Low-frequency NMES group
EXPERIMENTALPatients submitted to low-frequency NMES and SPT twice a day.
Medium-frequency NMES group
EXPERIMENTALPatients submitted to medium-frequency NMES and SPT twice a day.
Interventions
All participants have received standard physical therapy (SPT) sessions based on a passive range of motion mobilization protocol for the lower limbs. It consisted of a bilateral series of 10 repetitions of hip flexion, knee flexion and extension, and ankle flexion and extension. The procedure was performed twice a day: a morning (between 8am - 12pm) and an afternoon session (between 2pm - 6pm).
Electrical stimulation was performed twice a day after SPT. Two electrodes were attached to each thigh at the motor points of the quadriceps muscle. The point halfway between the anterior superior iliac spine and the base of the patella was used as reference and electrodes were placed 15 cm apart each other, 5 cm proximal and 10 cm distal from the reference point. After the first measurement, semi-permanent markers were used to indicate the position of electrodes. Electrical stimulation was performed using a 4-channels device (Sonopuls 492, series 4, Enraf-Nonius®, Rotterdam, Netherlands). The low-frequency protocol consisted of 100 Hz and 400 ms width pulses, delivered in trains of 5 s ON (ramp-up time: 1 s, plateau: 3 s, ramp-down time: 1 s) and 10 s OFF. Sessions had 20 min of duration (total of 40 min/day) and the current amplitude (mA) was adjusted to the identification of visible and palpable contractions and was rectified every 3 min to sustain the initial level of contraction.
Electrical stimulation was performed twice a day after SPT. Two electrodes were attached to each thigh at the motor points of the quadriceps muscle. The point halfway between the anterior superior iliac spine and the base of the patella was used as reference and electrodes were placed 15 cm apart each other, 5 cm proximal and 10 cm distal from the reference point. After the first measurement, semi-permanent markers were used to indicate the position of electrodes. Electrical stimulation was performed using a 4-channels device (Sonopuls 492, series 4, Enraf-Nonius®, Rotterdam, Netherlands).The medium-frequency protocol had similar parameters, but a carrier frequency of 2500 Hz and burst frequency of 100 Hz. Sessions had 20 min of duration (total of 40 min/day) and the current amplitude (mA) was adjusted to the identification of visible and palpable contractions and was rectified every 3 min to sustain the initial level of contraction.
Eligibility Criteria
You may qualify if:
- \- patients between 18-80 years old admitted in ICU with requirement of mechanical ventilation (MV) for longer than 72 h.
You may not qualify if:
- non-sedated patients;
- spinal cord injury;
- cerebrovascular accident;
- patients with pacemakers;
- history of deep vein thrombosis;
- pregnancy;
- cardiac complications (history of myocardial infarction or congenital diseases);
- use of neuromuscular blockers;
- polytraumatized patients requiring tutor support.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Internal Medicine, Faculty of Medicine, Universidad de La Frontera
Temuco, 4780000, Chile
Related Publications (1)
Guerra-Vega P, Guzman R, Betancourt C, Grage M, Vera C, Artigas-Arias M, Munoz-Cofre R, Vitzel KF, Marzuca-Nassr GN. Medium-Frequency Neuromuscular Electrical Stimulation in Critically Ill Patients Promoted Larger Functional Capacity Improvement During Recovery than Low-Frequency Neuromuscular Electrical Stimulation: Randomized Clinical Trial. J Clin Med. 2025 Jul 31;14(15):5407. doi: 10.3390/jcm14155407.
PMID: 40807029DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gabriel N Marzuca-Nassr,, PT, MSc, PhD
Universidad de La Frontera
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 19, 2022
First Posted
March 18, 2022
Study Start
August 1, 2019
Primary Completion
January 31, 2020
Study Completion
January 31, 2020
Last Updated
March 18, 2022
Record last verified: 2022-03