Critical IllnessNCT05287919
Neuromuscular Electrical Stimulation (NMES) Preserves Muscle Mass in Intensive Care Unit (ICU)
A study testing Patients received the standard physical therapy (SPT) programme (passive mobilization) twice a day., Patients received the low-frequency neuromuscular electrical stimulation (NMES) and Patients received the medium-frequency neuromuscular electrical stimulation (NMES) in people with Critical Illness and Physical Disability, run by Gabriel Nasri Marzuca-Nassr at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Critical Illness, Physical Disability, Muscle Atrophy
- What is being tested?
- Patients received the standard physical therapy (SPT) programme (passive mobilization) twice a day., Patients received the low-frequency neuromuscular electrical stimulation (NMES) and Patients received the medium-frequency neuromuscular electrical stimulation (NMES)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChile
- Study dates
- 1 Aug 2019to 31 Jan 2020
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients between 18-80 years old admitted in ICU with requirement of mechanical ventilation (MV) for longer than 72 h.
Who cannot join
- non-sedated patients;
- spinal cord injury;
- cerebrovascular accident;
- patients with pacemakers;
- history of deep vein thrombosis;
- pregnancy;
Show all 9Show fewer
- cardiac complications (history of myocardial infarction or congenital diseases);
- use of neuromuscular blockers;
- polytraumatized patients requiring tutor support.
Trial locations and contacts
1 site in 1 country.
Chile1 site
Department of Internal Medicine, Faculty of Medicine, Universidad de La Frontera
Temuco, 4780000
About this study
Official title: Effects of Low- and Medium-frequency Neuromuscular Electrical Stimulation on Skeletal Muscle Atrophy in Critically Ill Patients
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.
Read the detailed description
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.
Research question: The research question was is medium-frequency neuromuscular electrical stimulation (NMES) more effective than low-frequency NMES for the attenuation of skeletal muscle atrophy in critically ill patients?
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 muscle strength (MRC-SS), handgrip strength (dynamometry), functional status (FSS-ICU), degree of independence for activities of daily living (Barthel Index), functional mobility and dynamic balance (Timed Up and Go Test), quality of life (SF-36), and total days hospitalized.
- Conditions
- Critical Illness, Physical Disability, Muscle Atrophy
- Being tested
- Patients received the standard physical therapy (SPT) programme (passive mobilization) twice a day., Patients received the low-frequency neuromuscular electrical stimulation (NMES), Patients received the medium-frequency neuromuscular electrical stimulation (NMES)
- Keywords
- electrical stimulation therapy, skeletal muscle atrophy, critically ill patient, physical therapy, intensive care unit
- Medical subject headings
- Critical Illness, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients received the standard physical therapy (SPT) programme (passive mobilization) twice a day.Other
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).
Patients received the low-frequency neuromuscular electrical stimulation (NMES)Other
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.
Patients received the medium-frequency neuromuscular electrical stimulation (NMES)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Patients received the standard physical therapy (SPT) programme only (passive mobilization) twice a day. Receives: Other: Patients received the standard physical therapy (SPT) programme (passive mobilization) twice a day. |
| Low-frequency NMES group | Experimental | Patients submitted to low-frequency NMES and SPT twice a day. Receives: Other: Patients received the standard physical therapy (SPT) programme (passive mobilization) twice a day.; Other: Patients received the low-frequency neuromuscular electrical stimulation (NMES) |
| Medium-frequency NMES group | Experimental | Patients submitted to medium-frequency NMES and SPT twice a day. Receives: Other: Patients received the standard physical therapy (SPT) programme (passive mobilization) twice a day.; Other: Patients received the medium-frequency neuromuscular electrical stimulation (NMES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Day 1, Day 5, Day 9
Secondary outcomes (6)
Change in Clinical assessment of muscle strength while patients were in intensive care unit (ICU).
Clinical assessment of muscle strength via Medical Research Council-Sum Score (MRC-SS) (points), which ranges from 0 (complete paralysis) to 60 (normal strength).
Measured: Day 9, Day 11, Day 16, and Day 27
Change in Handgrip strength while patients were in hospital stay.
Handgrip strength via digital dynamometer (kg).
Measured: Day 9, Day 11, Day 16, and Day 27
Change in Functional status while patients were in Intensive Care unit (ICU).
Functional status via Functional Status Score for the Intensive Care Unit (FSS-ICU) (points). FSS-]ICU FSS-ICU score has a range of 0-35 with higher score indicating better functional status.
Measured: Day 9, Day 11, Day 16, and Day 27
Change in dynamic balance while patients were in hospital stay.
Dynamic balance via Timed Up and Go Test (seconds).
Measured: Day 16, and Day 27
Change in independence for activities of daily living while patients were in hospital stay.
Independence for activities of daily living via Barthel index (points). A patient scoring 0 points would be dependent in all assessed activities of daily living, whereas a score of 100 would reflect independence in these activities.
Measured: Day 16, and Day 27
Change in quality of life prior to hospital discharge.
Quality of life via Short Form 36 (SF-36) (points). The score go from 0 to 100. Higher scores mean a better outcome.
Measured: Day 27
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start1 Aug 2019
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gabriel Nasri Marzuca-Nassr
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gabriel Nasri Marzuca-Nassr, Universidad de La Frontera
- Investigators
- Gabriel N Marzuca-Nassr,, PT, MSc, PhD, Principal investigator, Universidad de La Frontera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05287919
- Sponsor's protocol ID
- Tesis UFRO #1676
- Status last verified
- Mar 2022
- First submitted
- 19 Feb 2022
- Last updated
- 18 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40807029
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low- and Medium-frequency Neuromuscular Electrical Stimulation on Skeletal Muscle Atrophy in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT05287919
- Acronym / sponsor ID
- Tesis UFRO #1676
- Conditions
- Critical Illness, Physical Disability, Muscle Atrophy
- Keywords
- electrical stimulation therapy, skeletal muscle atrophy, critically ill patient, physical therapy, intensive care unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Gabriel Nasri Marzuca-NassrUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 18 Mar 2022 (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.
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.
Detailed description
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.
Research question: The research question was is medium-frequency neuromuscular electrical stimulation (NMES) more effective than low-frequency NMES for the attenuation of skeletal muscle atrophy in critically ill patients?
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 muscle strength (MRC-SS), handgrip strength (dynamometry), functional status (FSS-ICU), degree of independence for activities of daily living (Barthel Index), functional mobility and dynamic balance (Timed Up and Go Test), quality of life (SF-36), and total days hospitalized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: Patients received the standard physical therapy (SPT) programme (passive mobilization) twice a day.Patients received the standard physical therapy (SPT) programme only (passive mobilization) twice a day. |
| Low-frequency NMES group | Experimental | Other: Patients received the standard physical therapy (SPT) programme (passive mobilization) twice a day., Other: Patients received the low-frequency neuromuscular electrical stimulation (NMES)Patients submitted to low-frequency NMES and SPT twice a day. |
| Medium-frequency NMES group | Experimental | Other: Patients received the standard physical therapy (SPT) programme (passive mobilization) twice a day., Other: Patients received the medium-frequency neuromuscular electrical stimulation (NMES)Patients submitted to medium-frequency NMES and SPT twice a day. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients between 18-80 years old admitted in ICU with requirement of mechanical ventilation (MV) for longer than 72 h.
Key exclusion criteria (9 listed)
- non-sedated patients;
- spinal cord injury;
- cerebrovascular accident;
- patients with pacemakers;
- history of deep vein thrombosis;
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 |
|---|---|---|
| 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 | Control group, Low-frequency NMES group, Medium-frequency NMES group |
| 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 | Low-frequency NMES group |
| 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. | Other | Medium-frequency NMES group |
Primary outcome
Change in thickness of the quadriceps muscle, evaluated with ultrasonography while patients were in intensive critical unit (ICU).
Time frame: Day 1, Day 5, Day 9
Thickness of the quadriceps muscle via ultrasonography (mm).
Change in quality of the quadriceps muscle, evaluated with ultrasonography while patients were in intensive critical unit (ICU).
Time frame: Day 1, Day 5, Day 9
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.
6 secondary outcomes
Change in Clinical assessment of muscle strength while patients were in intensive care unit (ICU).
Time frame: Day 9, Day 11, Day 16, and Day 27
Change in Handgrip strength while patients were in hospital stay.
Time frame: Day 9, Day 11, Day 16, and Day 27
Change in Functional status while patients were in Intensive Care unit (ICU).
Time frame: Day 9, Day 11, Day 16, and Day 27
Change in dynamic balance while patients were in hospital stay.
Time frame: Day 16, and Day 27
Change in independence for activities of daily living while patients were in hospital stay.
Time frame: Day 16, and Day 27
Change in quality of life prior to hospital discharge.
Time frame: Day 27
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 18 Mar 2022.
- Derived from this study: PubMed 40807029Guerra-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.
- Individual participant dataSharing planned: Undecided
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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.
Gabriel N Marzuca-Nassr,, PT, MSc, PhD principal investigator
Universidad de La Frontera
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients received the standard physical therapy (SPT) programme (passive mobilization) twice a day., Patients received the low-frequency neuromuscular electrical stimulation (NMES) and Patients received the medium-frequency neuromuscular electrical stimulation (NMES) in people with Critical Illness and Physical Disability, run by Gabriel Nasri Marzuca-Nassr at 1 site in Chile.
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 1 inclusion and 9 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 18 Mar 2022. 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 Chile. 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?
Change in thickness of the quadriceps muscle, evaluated with ultrasonography while patients were in intensive critical unit (ICU). (time frame: Day 1, Day 5, Day 9). The study lists 2 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 NCT05287919, which also lists 1 linked publication.
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 18 Mar 2022.