Intensive Care Unit Acquired WeaknessNCT04332263

Neuromuscular Electrical Stimulation in ICU Patients

A study testing Neuromuscular Electrical Stimulation - NMES in people with Intensive Care Unit Acquired Weakness, run by Federal University of Rio Grande do Sul at 1 site in Brazil.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Intensive Care Unit Acquired Weakness
What is being tested?: Neuromuscular Electrical Stimulation - NMES
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 56 participants
Where: 1 siteBrazil
Study dates: 1 Mar 2022to 6 Jun 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with any clinical condition hospitalized in the ICU, which are monitored by the Physiotherapy Service:
Cerebrovascular diseases
Other bacterial diseases
Circulatory and respiratory diseases
Digestive and abdominal diseases
Liver diseases
Time between the patient's ICU entry and the onset of the NMES intervention less than one week.
Patients may be in mechanical ventilation, non-invasive ventilation, oxygen therapy or oxygen ambient ventilation (no ventilatory add). Patients re-admitted to the ICU within the same hospitalization period (i.e., did not leave the hospital) may also be included, as well as patients with previous tracheostomy.

Who cannot join

Previously diagnosed neuromuscular diseases:
ALS
Guillain Barre
Chronic stroke
TRM
End-stage malignant disease

Show all 15Show fewer

Lower limbs' amputation
Body mass index above 40 kg/m2
Cachexia (defined as the presence of chronic disease and weight loss ≥ 5% in a period shorter than 12 months or BMI < 20 kg/m2, associated with at least three of the following criteria: (1) decreased muscle strength; (2) fatigue; (3) anorexia; (4) reduction of fat free mass index; and (5) biochemical abnormalities such as inflammation, anemia or reduction of serum albumin concentration).
Lesions on the skin at the electrode placement and/or dynamometer support points
Post-operative transplantation
Patients using a neuromuscular blocker
Hemodynamic instability (nora > 10; ABCDE criteria)
Height < 1.50m
Rhabdomyolysis

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Universidade Federal do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90690-200

Other trials in Brazil

About this study

Official title: Development and Application of a Portable Electrical Stimulator With Biofeedback to Increase Mobility and Improve the Neuromuscular Function of Critical Adult Patients in Intensive Care Units

Read the detailed description

The aim of the present study is to evaluate the effects of neuromuscular electrical stimulation (NMES) combined with conventional physiotherapy (Experimental Group), compared to conventional physiotherapy only (Control Group) in critically ill ICU patients, by means of a randomized controlled clinical trial. Primary outcomes evaluated during ICU patient's hospitalization are (1) the time spent in the ICU; (2) time of mechanical ventilation; (3) time and success of weaning (up to 48 hours), (4) the isometric torque from contractions artificially generated by NMES and evaluated by dynamometry; (5) muscle morphology and quality by means of ultrasonography. Secondary outcomes include (6) the sit and stand test; (7) gait speed test; (8) autonomic control (heart rate variability); (9) peripheral polyneuropathy by means of MRC scale; (10) Inflammatory profile - inflammatory (IL-6 and TNF-α) and anti-inflammatory (IL-10) cytokines; (11) blood muscular biochemical markers (IGF1, LDH, CK); (12) predictive mortality index for patients admitted to the ICU (SAPS 3); (13) survival rate; and (14) mobility (PERME). After discharge from the ICU or as soon as the patients are able to perform force voluntarily, the maximum voluntary torque will also be evaluated by means of dynamometry. Also, clinical data, hemodynamic variables, dosage of neuromuscular blockers and corticosteroids, blood glucose levels in the morning, daily water balance, oxygenation index, arterial blood gases, mechanical ventilator parameters, Glasgow scale, sedation scale (RASS), will be recorded daily. The investigators expect that the NMES program will be able to reduce muscle structure and function losses compared to control group, and will improve muscle quality, will reduce the ventilation time and the total time spent at the ICU, as well as improve functionality of these patients. In addition, the researchers expect to understand which mechanisms determine such adaptations in the musculoskeletal system of these patients.

Conditions: Intensive Care Unit Acquired Weakness
Being tested: Neuromuscular Electrical Stimulation - NMES

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Neuromuscular Electrical Stimulation - NMESOther
Also called Artificial electrical stimulation
NMES will be applied through an alternating biphasic current, with a stimulation frequency of 80 Hz and 1 ms pulse duration. Tetanic evoke forces (EF) at a 50% level of a supra-maximal single-pulse peak EF (i.e., 10-12% of a maximal voluntary isometric contraction) will be used. NMES protocol will be performed five times a week, lasting 20 minutes. Muscle fatigue will be evaluated every 5 min of the intervention, and will be used to determine the NMES protocol termination. A 10 % decrease in the single-pulse evoked torque between the evoked force produced pre- and during the NMES protocol will be used to terminate the fatigue protocol.

Study groups in NCT04332263
Study group	Role	What they receive
Neuromuscular Electrical Stimulation - NMES	Experimental	NMES will be applied bilaterally on the quadriceps femoris muscle of ICU patients. An electrical stimulation system and an ICU-designed dynamometer will be used with the patients lying in bed, with the hips and the knees flexed at 60 and 90 degrees, respectively. Supramaximal single-pulse's peak force will be used to determine the NMES intervention level. NMES (alternating biphasic current, stimulation frequency = 80 Hz, 1 ms pulse duration) will be used to evoke tetanic forces (EF) at 50% of the supra-maximal single-pulse EF (i.e., 10-12% of a maximal voluntary isometric contraction). NMES protocol will be performed five times a week, lasting 20 min. Muscle fatigue will be evaluated every 5 min of the intervention, and will be determined as a 10 % decrease in the single-pulse evoked torque between the evoked force produced pre- and during the NMES protocol. If and when a 10% reduction of the single-pulse EF is achieved, the intervention protocol will be terminated before the 20 min. Receives: Other: Neuromuscular Electrical Stimulation - NMES
Control Group - CG	No intervention	The control group (CG) will only perform conventional physiotherapy and will not receive any NMES training, but will be evaluated through the same evaluations and in the same moments of the two above mentioned intervention groups. Conventional physiotherapy will be given to all three groups.

What is being measured

The primary outcome is the main question the study is designed to answer.

Total ICU time
Total time of stay at the ICU, from admission to discharge (an average of 7 up to 15 days). Total ICU time will be collected from the patient's medical record.
Measured: Immediately after each patient discharge from the ICU (7 to 15 days after entry at the ICU, on average).
Mechanical ventilation time
Total time of mechanical ventilation, from patient intubation to weaning, will be collected from the patient's medical record.
Measured: Immediately after each patient mechanical ventilation release (2 to 5 days from intubation start, on average).
Weaning time
Time and success of weaning post-mechanical ventilation, from weaning to ICU discharge, will be collected from the medical record of the patient. The maintenance of spontaneous ventilation for at least 48 hours after discontinuation of artificial ventilation will be considered a successful weaning.
Measured: Immediately after each patient discharge from the ICU (7 to 15 days after entry at the ICU, on average).
Change in knee extensor evoked force
Knee extensor evoked force (EF) will be evaluated by means of isometric tests using a stainless steel dynamometry system instrumented with a load cell. EF will be evaluated through evoked contractions of the knee extensor muscles generated by supramaximal electrical stimuli with symmetrical rectangular biphasic current, applied in the form of single pulses (phase duration=1 ms, pulse duration=2 ms). At the beginning of the tests, the singular pulses will be applied with a manual trigger, and current intensity will be gradually increased (maximum 180 mA, inter-pulse interval = 3-5 second), until no further EF increase is observed. The current intensity required to reach the peak EF will then be increased by 10% to ensure supra-maximal stimulus during the tests. Three singular pulses will be applied and EF will be obtained by the mean value from the three evoked contractions. The change in knee extensor EF will be calculated as the difference in EF from ICU admission to ICU discharge.
Measured: Change from the patient ICU admission to immediately before ICU discharge (e.g., from day 1 to day 7-15, on average).
Knee extensor maximal voluntary isometric contraction
Maximal knee extensor strength capacity during voluntary effort will be assessed only when the patient is discharged (POST) from ICU, by performing maximum voluntary isometric contractions (MVICs). To do so, once properly positioned on the dynamometer, subjects will perform three knee extensor MVICs, maintaining each contraction for a 5 sec period each. Subjects will be instructed to perform the contractions without any visual feedback, rapidly increasing the effort until they reach the maximum torque production, which should be maintained until the verbal command to cease contraction. Two-minute intervals will be given between contractions. The highest torque value recorded during the three MVICs will be adopted as the maximum voluntary effort (maximal torque). Mean and standard deviation values from the MVICs will be calculated for the experimental groups.
Measured: Immediately before each patient ICU discharge (7 to 15 days after admission, on average).
Knee extensor muscle quality: Real-time ultrasound 9 MHz frequency
Real-time ultrasound (Vivid-I, General Electric, USA) obtained with a linear array probe (4 cm wide) and a 9 MHz sampling frequency will be used for the evaluation of muscle quality. Images from the rectus femoris (RF) muscle will be obtained with the participants at rest. Ultrasound images will be captured in the muscle's transverse plane, at 50% of the muscle's belly. To ensure the ultrasound images comparison at different times, the brightness and contrast settings will be maintained at 50% during all evaluations. Muscle quality will be determined using a standard function of the Image-J (National Institute of Health, USA) software. A region of interest that includes as much muscle area as possible, avoiding the fascia, will be selected from the RF muscle images. Muscle quality will be determined by analysing the image's average gray scale, which ranges from total black (0) to total white (255), and mean values from three ultrasound images will be determined.
Measured: Immediately after each patient ICU admission and immediately before ICU discharge (7 to 15 days on average).
Rectus femoris cross-sectional area
RF cross-sectional area (CSA) will be captured at rest in the muscle's transverse plane, at 70% of the muscle belly. The probe will be positioned transversely to the muscle belly, with the image depth adjusted so that both the RF superficial and deep aponeuroses can be visualized. RF CSA will be obtained through the analysis of these transverse images. A standard function of the Image-J (National Institute of Health, USA) software will be used, which allows the demarcation of the muscular perimeter (excluding the aponeuroses), and calculates the internal selected area (cm2). The mean CSA value from three images will be calculated for each group at each time-point of the study.
Measured: Immediately after each patient ICU admission and immediately before ICU discharge (7 to 15 days on average).
Knee extensors muscle thickness
Muscle thickness (MT) will be obtained at rest from ultrasound images of the RF, vastus intermedius (VI), vastus lateralis (VL) and vastus medialis (VM) muscles. Ultrasound images will be captured at 50% of the RF, VI and VL muscle bellies, and at 70% of the VM length. MT will be obtained by image analysis in the Image-J software (National Institute of Health, USA). Five equidistant measurements will be taken from the superficial to deep aponeurosis of the VI, VL and VM muscles. RF diameter will be obtained from the transverse image obtained for muscle quality evaluation and will represent its MT. The mean value of the five measures of the VI, VL and VM muscles will be calculated for each image. The mean MT value from three ultrasound images will be calculated and will be used as the MT from each evaluated muscle (in cm).
Measured: Immediately after each patient ICU admission and immediately before ICU discharge (7 to 15 days on average).

Secondary outcomes (20)

Sit to stand test
The sit to stand test measures the total time required to perform 5 repetitions of the sit to stand movement on a chair. The test begins with the participant sitting on a chair with trunk support, feet at a shoulder-width apart, and fully resting on the ground. The upper limbs will be crossed at chest height. At the "start signal", the participant moves to the standing position, rising to the upright position (vertical position), and next returning to the initial sitting position. The test results will consist of assessing the total time taken by the patient to perform five repetitions of the movement of getting up and sitting down on the chair as quickly as possible.
Measured: Immediately after each patient ICU discharge (7 to 15 days after admission, on average).
Waking Speed Test
The Walking Speed Test will be performed in a flat corridor, in which the patient is asked to walk as fast as possible a 10-meter distance previously marked on the ground. The travel time in the central 6 meters of the 10-meter distance will be measured. Running speed ≤ 0.8 m/s will be considered as low physical performance. Patients will be familiarized with the test by the evaluator simulating the test performance prior to the test.
Measured: Immediately after each patient ICU discharge, until study completion (about 30 months).
Heart rate variability
Heart rate variability (HRV) will be evaluated by recording the heart rate at the beginning of the tests, at the second half of a 10-min rest for HRV baseline values assessment. After that, HRV will be obtained during the NMES protocols. HRV records will be obtained with a Polar heart rate monitor (POLAR RS800CX, USA) that will be placed on the subjects' precordium region. Data analysis will be performed by studying the heartbeats RR intervals imported into Kubios software (version 3.0.2, Finland). Analyzes will be performed in the domains of (1) time, by means of both the mean heart rate (beats/min) and the mean values of the intervals between the R-waves (ms); and (2) frequency, by calculating both the spectral power values of the low frequency (LF) and high frequency (HF) components (normalized unit; n.u.). Five-minute windows will be analyzed, obtained from the second half of the REST period just before the tests, and 5 min within the second half of the NMES protocol.
Measured: Immediately before and during NMES intervention protocols (daily, from 7 to 15 days on average).
Peripheral polyneuropathy
Peripheral polyneuropathy will be assessed through the MRC (Medical Research Council) scale. Three muscle groups in all four limbs will be evaluated through this scale, with values ranging from 0 (quadriplegia) to 60 points (normal muscle strength). The following functions will be evaluated: wrist flexion, forearm flexion, abduction of the shoulder, ankle dorsiflexion, knee extension and hip flexion. Patients with a score lower than 48 out of 60 points will be diagnosed with peripheral polyneuropathy.
Measured: Immediately before ICU discharge (7 to 15 days after admission, on average).
Inflammatory profile
Immunological reagents will be used to detect anti and pro-inflammatory cytokines. The serum production of IL-6, IL-10 and TNF-α will be determined by ELISA.
Measured: Immediately after each patient ICU admission and immediately before ICU discharge (7 to 15 days on average).
Muscular biochemical markers
The IGF1, creatine kinase and phosphocreatine markers will be analyzed from blood collection in a serum tube with EDTA. The blood will be centrifuged in refrigerated medium for 15 minutes at 3000g and the plasma will be stored separately in a freezer at -80°C for analysis of these markers.
Measured: Immediately after each patient ICU admission and immediately before ICU discharge (7 to 15 days on average).
Mobility (PERME)
This instrument comprises 15 items grouped into 7 categories (scored from 0 to 32 points in total): (1) mental state, which evaluates the ability of patients to obey commands; (2) potential barriers to mobility, which verifies the presence of devices that can impede mobility; (3) strength, which evaluates the ability to perform both hip flexion above 20º with extended knee, as well as shoulder flexion above 45º with elbows extended; (4) in bed mobility, which refers to the ability to transfer from dorsal decubitus to the seated position, and maintenance of the seated position at the bedside; (5) transfers, which refers to the ability to transfer from sitting to standing, orthostatism and transfer from the bed to the armchair are evaluated; (6) gait, which is assessed as the ability to walk (or not) with severe, moderate or little assistance; (7) endurance, which is the ability to walk a certain amount of steps in 2 minutes. In this instrument, a high score indicates high mobility.
Measured: Immediately before each patient ICU discharge (7 to 15 days after admission, on average).
Arterial pressure
Systemic arterial pressure (mmHg) and mean arterial pressure (mmHg), collected from medical records.
Measured: Daily from ICU admission to discharge day (7 to 15 days on average).
Heart rate
Mean heart rate (bpm), collected from medical records.
Measured: Daily from ICU admission to discharge day (7 to 15 days on average).
Ventilatory mode
Ventilatory mode (PCV, VCV, PSV), collected from medical records.
Measured: Daily from ICU admission to discharge day (7 to 15 days on average).
Tidal volume
Tidal volume (ml), collected from medical records.
Measured: Daily from ICU admission to discharge day (7 to 15 days on average).
Ventilator frequency
Ventilator frequency (rpm), collected from medical records.
Measured: Daily from ICU admission to discharge day (7 to 15 days on average).
Sensitivity
Sensitivity (cmH2O or L/min), collected from medical records.
Measured: Daily from ICU admission to discharge day (7 to 15 days on average).
FiO2
FiO2 (%), collected from medical records.
Measured: Daily from ICU admission to discharge day (7 to 15 days on average).
PEEP
PEEP (cmH2O), collected from medical records.
Measured: Daily from ICU admission to discharge day (7 to 15 days on average).
Water balance
Water balance (mL), collected from medical records.
Measured: Daily from ICU admission to discharge day (7 to 15 days on average).
Oxygenation rate
Oxygenation rate (PaO2 / FiO2 ratio), collected from medical records.
Measured: Daily from ICU admission to discharge day (7 to 15 days on average).
Arterial blood gas analysis
PaCO2 (mmHg), PaO2 (mmHg) and HCO3- (mEq/L), collected from medical records.
Measured: Daily from ICU admission to discharge day (7 to 15 days on average).
Glasgow scale
Glasgow scale (range 3-15), collected from medical records.
Measured: Daily from ICU admission to discharge day (7 to 15 days on average).
RAMSAY scale
RAMSAY scale (range -5 to +4), collected from medical records.
Measured: Daily from ICU admission to discharge day (7 to 15 days on average).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 20226 Jun 2024

First posted2 Apr 2020
Study start1 Mar 2022
Primary completion1 Mar 2022
Study completion6 Jun 2024

Why it stopped: Due to the pandemic we were unable to recruit patients from the hospital

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Intensive Care Unit Acquired WeaknessStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: The present study is a randomized controlled trial, which followed the recommendations proposed by the CONSORT Statement
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04332263
Sponsor's protocol ID: 36588914.4.1001.5347
Status last verified: Jun 2024
First submitted: 7 Jun 2019
Last updated: 10 Jun 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Beyond Voluntary Effort: Reliability and Validity of Magnetic Femoral Nerve Stimulation for Assessing Quadriceps Strength in Critically Ill Patient
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Pediatric Intensive Care Units

All Intensive Care Unit Acquired Weakness trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Development and Application of a Portable Electrical Stimulator With Biofeedback to Increase Mobility and Improve the Neuromuscular Function of Critical Adult Patients in Intensive Care Units
ClinicalTrials.gov ID: NCT04332263
Acronym / sponsor ID: 36588914.4.1001.5347
Conditions: Intensive Care Unit Acquired Weakness
Study type: Interventional
Recruitment status: TerminatedReason stopped: Due to the pandemic we were unable to recruit patients from the hospital
Enrolment: 56 participants (actual)
Lead sponsor: Federal University of Rio Grande do SulUniversity, hospital or other
Study start: 1 Mar 2022 (actual)
Primary completion: 1 Mar 2022 (actual)
Study completion: 6 Jun 2024 (actual)
First posted: 2 Apr 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
Model description: The present study is a randomized controlled trial, which followed the recommendations proposed by the CONSORT Statement

Arm	Type	Receives
Neuromuscular Electrical Stimulation - NMES	Experimental	Other: Neuromuscular Electrical Stimulation - NMESNMES will be applied bilaterally on the quadriceps femoris muscle of ICU patients. An electrical stimulation system and an ICU-designed dynamometer will be used with the patients lying in bed, with the hips and the knees flexed at 60 and 90 degrees, respectively. Supramaximal single-pulse's peak force will be used to determine the NMES intervention level. NMES (alternating biphasic current, stimulation frequency = 80 Hz, 1 ms pulse duration) will be used to evoke tetanic forces (EF) at 50% of the supra-maximal single-pulse EF (i.e., 10-12% of a maximal voluntary isometric contraction). NMES protocol will be performed five times a week, lasting 20 min. Muscle fatigue will be evaluated every 5 min of the intervention, and will be determined as a 10 % decrease in the single-pulse evoked torque between the evoked force produced pre- and during the NMES protocol. If and when a 10% reduction of the single-pulse EF is achieved, the intervention protocol will be terminated before the 20 min.
Control Group - CG	No intervention	–The control group (CG) will only perform conventional physiotherapy and will not receive any NMES training, but will be evaluated through the same evaluations and in the same moments of the two above mentioned intervention groups. Conventional physiotherapy will be given to all three groups.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Patients with any clinical condition hospitalized in the ICU, which are monitored by the Physiotherapy Service:
Cerebrovascular diseases
Other bacterial diseases
Circulatory and respiratory diseases
Digestive and abdominal diseases

Key exclusion criteria (15 listed)

Previously diagnosed neuromuscular diseases:
ALS
Guillain Barre
Chronic stroke
TRM

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Neuromuscular Electrical Stimulation - NMESAlso: Artificial electrical stimulationNMES will be applied through an alternating biphasic current, with a stimulation frequency of 80 Hz and 1 ms pulse duration. Tetanic evoke forces (EF) at a 50% level of a supra-maximal single-pulse peak EF (i.e., 10-12% of a maximal voluntary isometric contraction) will be used. NMES protocol will be performed five times a week, lasting 20 minutes. Muscle fatigue will be evaluated every 5 min of the intervention, and will be used to determine the NMES protocol termination. A 10 % decrease in the single-pulse evoked torque between the evoked force produced pre- and during the NMES protocol will be used to terminate the fatigue protocol.	Other	Neuromuscular Electrical Stimulation - NMES

Primary outcome

Total ICU time
Time frame: Immediately after each patient discharge from the ICU (7 to 15 days after entry at the ICU, on average).
Total time of stay at the ICU, from admission to discharge (an average of 7 up to 15 days). Total ICU time will be collected from the patient's medical record.
Mechanical ventilation time
Time frame: Immediately after each patient mechanical ventilation release (2 to 5 days from intubation start, on average).
Total time of mechanical ventilation, from patient intubation to weaning, will be collected from the patient's medical record.
Weaning time
Time frame: Immediately after each patient discharge from the ICU (7 to 15 days after entry at the ICU, on average).
Time and success of weaning post-mechanical ventilation, from weaning to ICU discharge, will be collected from the medical record of the patient. The maintenance of spontaneous ventilation for at least 48 hours after discontinuation of artificial ventilation will be considered a successful weaning.
Change in knee extensor evoked force
Time frame: Change from the patient ICU admission to immediately before ICU discharge (e.g., from day 1 to day 7-15, on average).
Knee extensor evoked force (EF) will be evaluated by means of isometric tests using a stainless steel dynamometry system instrumented with a load cell. EF will be evaluated through evoked contractions of the knee extensor muscles generated by supramaximal electrical stimuli with symmetrical rectangular biphasic current, applied in the form of single pulses (phase duration=1 ms, pulse duration=2 ms). At the beginning of the tests, the singular pulses will be applied with a manual trigger, and current intensity will be gradually increased (maximum 180 mA, inter-pulse interval = 3-5 second), until no further EF increase is observed. The current intensity required to reach the peak EF will then be increased by 10% to ensure supra-maximal stimulus during the tests. Three singular pulses will be applied and EF will be obtained by the mean value from the three evoked contractions. The change in knee extensor EF will be calculated as the difference in EF from ICU admission to ICU discharge.
Knee extensor maximal voluntary isometric contraction
Time frame: Immediately before each patient ICU discharge (7 to 15 days after admission, on average).
Maximal knee extensor strength capacity during voluntary effort will be assessed only when the patient is discharged (POST) from ICU, by performing maximum voluntary isometric contractions (MVICs). To do so, once properly positioned on the dynamometer, subjects will perform three knee extensor MVICs, maintaining each contraction for a 5 sec period each. Subjects will be instructed to perform the contractions without any visual feedback, rapidly increasing the effort until they reach the maximum torque production, which should be maintained until the verbal command to cease contraction. Two-minute intervals will be given between contractions. The highest torque value recorded during the three MVICs will be adopted as the maximum voluntary effort (maximal torque). Mean and standard deviation values from the MVICs will be calculated for the experimental groups.
Knee extensor muscle quality: Real-time ultrasound 9 MHz frequency
Time frame: Immediately after each patient ICU admission and immediately before ICU discharge (7 to 15 days on average).
Real-time ultrasound (Vivid-I, General Electric, USA) obtained with a linear array probe (4 cm wide) and a 9 MHz sampling frequency will be used for the evaluation of muscle quality. Images from the rectus femoris (RF) muscle will be obtained with the participants at rest. Ultrasound images will be captured in the muscle's transverse plane, at 50% of the muscle's belly. To ensure the ultrasound images comparison at different times, the brightness and contrast settings will be maintained at 50% during all evaluations. Muscle quality will be determined using a standard function of the Image-J (National Institute of Health, USA) software. A region of interest that includes as much muscle area as possible, avoiding the fascia, will be selected from the RF muscle images. Muscle quality will be determined by analysing the image's average gray scale, which ranges from total black (0) to total white (255), and mean values from three ultrasound images will be determined.
Rectus femoris cross-sectional area
Time frame: Immediately after each patient ICU admission and immediately before ICU discharge (7 to 15 days on average).
RF cross-sectional area (CSA) will be captured at rest in the muscle's transverse plane, at 70% of the muscle belly. The probe will be positioned transversely to the muscle belly, with the image depth adjusted so that both the RF superficial and deep aponeuroses can be visualized. RF CSA will be obtained through the analysis of these transverse images. A standard function of the Image-J (National Institute of Health, USA) software will be used, which allows the demarcation of the muscular perimeter (excluding the aponeuroses), and calculates the internal selected area (cm2). The mean CSA value from three images will be calculated for each group at each time-point of the study.
Knee extensors muscle thickness
Time frame: Immediately after each patient ICU admission and immediately before ICU discharge (7 to 15 days on average).
Muscle thickness (MT) will be obtained at rest from ultrasound images of the RF, vastus intermedius (VI), vastus lateralis (VL) and vastus medialis (VM) muscles. Ultrasound images will be captured at 50% of the RF, VI and VL muscle bellies, and at 70% of the VM length. MT will be obtained by image analysis in the Image-J software (National Institute of Health, USA). Five equidistant measurements will be taken from the superficial to deep aponeurosis of the VI, VL and VM muscles. RF diameter will be obtained from the transverse image obtained for muscle quality evaluation and will represent its MT. The mean value of the five measures of the VI, VL and VM muscles will be calculated for each image. The mean MT value from three ultrasound images will be calculated and will be used as the MT from each evaluated muscle (in cm).

20 secondary outcomes

Sit to stand test
Time frame: Immediately after each patient ICU discharge (7 to 15 days after admission, on average).
Waking Speed Test
Time frame: Immediately after each patient ICU discharge, until study completion (about 30 months).
Heart rate variability
Time frame: Immediately before and during NMES intervention protocols (daily, from 7 to 15 days on average).
Peripheral polyneuropathy
Time frame: Immediately before ICU discharge (7 to 15 days after admission, on average).
Inflammatory profile
Time frame: Immediately after each patient ICU admission and immediately before ICU discharge (7 to 15 days on average).
Muscular biochemical markers
Time frame: Immediately after each patient ICU admission and immediately before ICU discharge (7 to 15 days on average).
Mobility (PERME)
Time frame: Immediately before each patient ICU discharge (7 to 15 days after admission, on average).
Arterial pressure
Time frame: Daily from ICU admission to discharge day (7 to 15 days on average).
Heart rate
Time frame: Daily from ICU admission to discharge day (7 to 15 days on average).
Ventilatory mode
Time frame: Daily from ICU admission to discharge day (7 to 15 days on average).
Tidal volume
Time frame: Daily from ICU admission to discharge day (7 to 15 days on average).
Ventilator frequency
Time frame: Daily from ICU admission to discharge day (7 to 15 days on average).
Sensitivity
Time frame: Daily from ICU admission to discharge day (7 to 15 days on average).
FiO2
Time frame: Daily from ICU admission to discharge day (7 to 15 days on average).
PEEP
Time frame: Daily from ICU admission to discharge day (7 to 15 days on average).
Water balance
Time frame: Daily from ICU admission to discharge day (7 to 15 days on average).
Oxygenation rate
Time frame: Daily from ICU admission to discharge day (7 to 15 days on average).
Arterial blood gas analysis
Time frame: Daily from ICU admission to discharge day (7 to 15 days on average).
Glasgow scale
Time frame: Daily from ICU admission to discharge day (7 to 15 days on average).
RAMSAY scale
Time frame: Daily from ICU admission to discharge day (7 to 15 days on average).

Results and safety

The study was stopped early (reason given: Due to the pandemic we were unable to recruit patients from the hospital). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marco A Vaz, PhD principal investigator

Federal University of Rio Grande do Sul

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Neuromuscular Electrical Stimulation - NMES in people with Intensive Care Unit Acquired Weakness, run by Federal University of Rio Grande do Sul at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Due to the pandemic we were unable to recruit patients from the hospital). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total ICU time (time frame: Immediately after each patient discharge from the ICU (7 to 15 days after entry at the ICU, on average).). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04332263.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2024.