Intensive Care Unit Acquired WeaknessNCT06409611
Muscle Effects Of Neuromuscular Electrostimulation In Mechanically Ventilated Patients In An Icu
A study testing neuromuscular electrical stimulation in people with Intensive Care Unit Acquired Weakness, run by Universidade Federal do Rio de Janeiro at 3 sites in Brazil.
Trial summary
To prevent the development of ICUAW, both early mobilization and neuromuscular electrical stimulation (NMES) have been shown to prevent muscle atrophy in critically ill patients by preserving muscle mass. Read more about this study
- 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 3 sitesBrazil
- Study dates
- 1 May 2024to 30 Jul 2025
- 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
- Age ≥18 years;
- On mechanical ventilation in the first 24 hours;
- Provision of written, informed and/or agreed consent for a family member.
Who cannot join
- Trauma to the lower limb;
- History of neurological, neuromuscular or debilitating diseases;
- Spinal cord injury;
- Rhabdomyolysis;
- Vascular insufficiency or amputation of the lower limb;
- Previous immobility;
- Epilepsy;
- Musculoskeletal and skin conditions or situations that may interfere in conduct.
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites
Pedro Ernesto University Hospital
Rio de Janeiro, Rio de Janeiro, 20551-030
State University of Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, 20551-030
Universidade do Estado do Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, 20950-000
About this study
To prevent the development of ICUAW, both early mobilization and neuromuscular electrical stimulation (NMES) have been shown to prevent muscle atrophy in critically ill patients by preserving muscle mass. Furthermore, it is of great value that muscle assessment using kinesiological ultrasound becomes routine to monitor this patient's profile with regard to strength, muscle quality and muscle mass. Our objective is to evaluate the muscular changes promoted by NMES in patients under mechanical ventilation. This is a randomized clinical trial study, which will perform NMES sessions for at least 7 days in mechanically ventilated patients. They will also undergo ultrasound assessments of the quadriceps. Patients will be divided into a control group and an NMES group. In addition, general information recorded in the medical record will be collected, such as basic characteristics, laboratory tests and general assessments.
Read the detailed description
This is a randomized clinical trial study, which will be carried out at the Hospital Universitário Pedro Ernesto between the months of May 2024 and November 2025, where patients admitted to the General CTI will undergo muscle assessments through ultrasound and a protocol of NMES over a period of 7 days. Participants will be randomized and allocated into 2 groups: Control and NMES. After randomization, general information recorded in the medical record will be collected, such as baseline characteristics, laboratory tests, general assessments, Sequential Organ Failure Assessment Score (SOFA), Chelsea Critical Care Physical Assessment Tool (CPAx) functional scale, edema classification, quality and type of contraction during each NMES session, days on pressure support ventilation (PSV) and pressure or volume assist-controlled ventilation (PCV or VCV), use of neuromuscular blocker, corticosteroids, vasoactive amine and the type and days of diet. Patients will undergo ultrasound evaluation of the pennation angle (AP) of the vastus lateralis, cross-sectional area (CSA) of the rectus femoris, thickness (ESP) of the quadriceps and echogenicity (ECHO) of the rectus femoris, within the first 24h post intubation, at 3 days and 7 days post intubation. Muscle assessment was carried out by professional physiotherapists trained and certified for this purpose. For the NMES group, NMES therapy will be performed for 1 hour, once a day and for 7 days. Using the following parameters: Biphasic and symmetrical rectangular pulse, with a frequency of 50Hz, pulse width of 500μs, ON time of 10 seconds, OFF time of 15 seconds, 3 seconds of rise time and 2 seconds of descent time. The intensity is increased to the point that there is complete muscle contraction, visible or palpable. The maximum intensity will be 120 mA.
- Conditions
- Intensive Care Unit Acquired Weakness
- Being tested
- neuromuscular electrical stimulation
- Keywords
- neuromuscular electrical stimulation, Intensive Care Unit Acquired Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuromuscular electrical stimulationDevice
Application of neuromuscular electrical stimulation using the NeuroDyn III device (IBRAMED, Amparo - SP)
| Study group | Role | What they receive |
|---|---|---|
| neuromuscular electrical stimulation (NMES) | Experimental | For the NMES group, NMES therapy will be performed for 1 hour, once a day and for 10 days. Using the following parameters: Biphasic and symmetrical rectangular pulse, with a frequency of 50Hz, pulse width of 500μs, ON time of 10 seconds, OFF time of 15 seconds, 3 seconds of rise time and 2 seconds of descent time. The intensity is increased to the point that there is complete muscle contraction, visible or palpable. The maximum intensity will be 120 mA. Receives: Device: neuromuscular electrical stimulation |
| Placebo | Active comparator | This group will perform conventional physiotherapy according to institutional protocol. Rehabilitation was oriented towards achieving daily motor milestones (sitting on the edge of the bed, sitting in an armchair, getting up and walking) according to the CPAx scale. The same electrostimulation device will be installed, but it will not be turned on. Receives: Device: neuromuscular electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pennation angle (degrees)
Pennation angle measured by ultrasound
Measured: First, fifth and tenth days.
Secondary outcomes (6)
Cross-sectional area (cm2)
Cross-sectional area (cm2) measured by ultrasound
Measured: First, fifth and tenth days.
Echogenicity (AU)
Echogenicity (AU) measured by ultrasound
Measured: First, fifth and tenth days.
Thickness (cm)
Thickness (cm) measured by ultrasound
Measured: First, fifth and tenth days.
Days free from mechanical ventilation
Days free from mechanical ventilation within a 28-day interval.
Measured: 28-day interval.
Extubation success rate (%)
Extubation success rate (%)
Measured: 28-day interval.
ICU mortality rate (%).
ICU mortality rate (%).
Measured: 28-day interval.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start1 May 2024
- Primary completion30 Jun 2025
- Study completion30 Jul 2025
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
- fes/parametros
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Pedro Ernesto
- Responsible party
- Principal investigator, Jose Roberto Lapa e Silva, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06409611
- Sponsor's protocol ID
- 07071995
- Status last verified
- Apr 2026
- First submitted
- 7 May 2024
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Effects Of Neuromuscular Electrostimulation In Mechanically Ventilated Patients In An Icu
- ClinicalTrials.gov ID
- NCT06409611
- Acronym / sponsor ID
- 07071995
- Conditions
- Intensive Care Unit Acquired Weakness
- Keywords
- neuromuscular electrical stimulation, Intensive Care Unit Acquired Weakness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Collaborators
- Hospital Universitario Pedro Ernesto
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 10 May 2024 (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.
To prevent the development of ICUAW, both early mobilization and neuromuscular electrical stimulation (NMES) have been shown to prevent muscle atrophy in critically ill patients by preserving muscle mass. Furthermore, it is of great value that muscle assessment using kinesiological ultrasound becomes routine to monitor this patient's profile with regard to strength, muscle quality and muscle mass. Our objective is to evaluate the muscular changes promoted by NMES in patients under mechanical ventilation. This is a randomized clinical trial study, which will perform NMES sessions for at least 7 days in mechanically ventilated patients. They will also undergo ultrasound assessments of the quadriceps. Patients will be divided into a control group and an NMES group. In addition, general information recorded in the medical record will be collected, such as basic characteristics, laboratory tests and general assessments.
Detailed description
This is a randomized clinical trial study, which will be carried out at the Hospital Universitário Pedro Ernesto between the months of May 2024 and November 2025, where patients admitted to the General CTI will undergo muscle assessments through ultrasound and a protocol of NMES over a period of 7 days. Participants will be randomized and allocated into 2 groups: Control and NMES. After randomization, general information recorded in the medical record will be collected, such as baseline characteristics, laboratory tests, general assessments, Sequential Organ Failure Assessment Score (SOFA), Chelsea Critical Care Physical Assessment Tool (CPAx) functional scale, edema classification, quality and type of contraction during each NMES session, days on pressure support ventilation (PSV) and pressure or volume assist-controlled ventilation (PCV or VCV), use of neuromuscular blocker, corticosteroids, vasoactive amine and the type and days of diet. Patients will undergo ultrasound evaluation of the pennation angle (AP) of the vastus lateralis, cross-sectional area (CSA) of the rectus femoris, thickness (ESP) of the quadriceps and echogenicity (ECHO) of the rectus femoris, within the first 24h post intubation, at 3 days and 7 days post intubation. Muscle assessment was carried out by professional physiotherapists trained and certified for this purpose. For the NMES group, NMES therapy will be performed for 1 hour, once a day and for 7 days. Using the following parameters: Biphasic and symmetrical rectangular pulse, with a frequency of 50Hz, pulse width of 500μs, ON time of 10 seconds, OFF time of 15 seconds, 3 seconds of rise time and 2 seconds of descent time. The intensity is increased to the point that there is complete muscle contraction, visible or palpable. The maximum intensity will be 120 mA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- fes/parametros
| Arm | Type | Receives |
|---|---|---|
| neuromuscular electrical stimulation (NMES) | Experimental | Device: neuromuscular electrical stimulationFor the NMES group, NMES therapy will be performed for 1 hour, once a day and for 10 days. Using the following parameters: Biphasic and symmetrical rectangular pulse, with a frequency of 50Hz, pulse width of 500μs, ON time of 10 seconds, OFF time of 15 seconds, 3 seconds of rise time and 2 seconds of descent time. The intensity is increased to the point that there is complete muscle contraction, visible or palpable. The maximum intensity will be 120 mA. |
| Placebo | Active comparator | Device: neuromuscular electrical stimulationThis group will perform conventional physiotherapy according to institutional protocol. Rehabilitation was oriented towards achieving daily motor milestones (sitting on the edge of the bed, sitting in an armchair, getting up and walking) according to the CPAx scale. The same electrostimulation device will be installed, but it will not be turned on. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years;
- On mechanical ventilation in the first 24 hours;
- Provision of written, informed and/or agreed consent for a family member.
Key exclusion criteria (8 listed)
- Trauma to the lower limb;
- History of neurological, neuromuscular or debilitating diseases;
- Spinal cord injury;
- Rhabdomyolysis;
- Vascular insufficiency or amputation of the lower limb;
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 stimulationApplication of neuromuscular electrical stimulation using the NeuroDyn III device (IBRAMED, Amparo - SP) | Device | Placebo, neuromuscular electrical stimulation (NMES) |
Primary outcome
Pennation angle (degrees)
Time frame: First, fifth and tenth days.
Pennation angle measured by ultrasound
6 secondary outcomes
Cross-sectional area (cm2)
Time frame: First, fifth and tenth days.
Echogenicity (AU)
Time frame: First, fifth and tenth days.
Thickness (cm)
Time frame: First, fifth and tenth days.
Days free from mechanical ventilation
Time frame: 28-day interval.
Extubation success rate (%)
Time frame: 28-day interval.
ICU mortality rate (%).
Time frame: 28-day interval.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites 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 in people with Intensive Care Unit Acquired Weakness, run by Universidade Federal do Rio de Janeiro at 3 sites 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pennation angle (degrees) (time frame: First, fifth and tenth days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2026.