Neuromuscular Electrical Stimulation (NMES) Preserves Muscle Mass in Intensive Care Unit (ICU)

NCT05287919 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2022-03-18

No results posted yet for this study

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.

Conditions

  • Critical Illness
  • Physical Disability
  • Muscle Atrophy

Interventions

OTHER

Patients received the standard physical therapy (SPT) programme (passive mobilization) twice a day.

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).

OTHER

Patients received the low-frequency neuromuscular electrical stimulation (NMES)

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.

OTHER

Patients received the medium-frequency neuromuscular electrical stimulation (NMES)

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.

Sponsors & Collaborators

  • Gabriel Nasri Marzuca-Nassr

    lead OTHER

Principal Investigators

  • Gabriel N Marzuca-Nassr,, PT, MSc, PhD · Universidad de La Frontera

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2020-01-31
Completion
2020-01-31

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05287919 on ClinicalTrials.gov