ICU Acquired WeaknessNCT05919940
Improved Muscle Metabolism by Combination of Muscle Activation and Protein Substitution ( IMEMPRO )
A study testing Dietary Supplement: additional substitution of protein, Neuromuscular electrical stimulation and Early Mobilization in people with ICU Acquired Weakness and Muscle Atrophy, run by Technical University of Munich at 4 sites in 2 countries.
Trial summary
Intensive Care Unit Acquired Weakness (ICUAW) describes muscle weakness that occurs in around 40% of patients during an intensive care stay. The morbidity and mortality of these patients is significantly increased over a 5-year period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICU Acquired Weakness, Muscle Atrophy, Energy Malnutrition Protein
- What is being tested?
- Dietary Supplement: additional substitution of protein, Neuromuscular electrical stimulation and Early Mobilization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 27 Jun 2023to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- critically ill adults (≥ 18 years of age)
- newly admitted to the ICU (<48h)
- mechanically ventilated, expected to remain for at least 72h
- enteral nutrition is feasible
Who cannot join
- a BMI > 30
- expected death or withdrawal of life-sustaining treatments
- prior neuromuscular disease (e.g. paresis, myopathies, neuropathies)
- injury or disease preventing neuromuscular electrical stimulation or early mobilization (e.g., elevated intracranial pressure, unstable spine)
- a pacemaker or other electronic implant
- allergy to components of NMES adhesive
- have been dependent during activities of daily living prior to the hospital admission
- a language barrier
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Marian Demitsch contact
4 sites in 2 countries
Germany3 sites, 1 recruiting
- Active, not recruiting
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, 10117
- Active, not recruiting
Klinikum rechts der Isar, School of Medicine, Technical Universtity of Munich
Munich, Bavaria, 81675
- Recruiting
Universitätsklinikum Ulm
Ulm, 89070
Flora Scheffenbichler, MD, flora.scheffenbichler@uni-ulm.de
Bettina Jungwirth, MD, ains@uniklinik- ulm.de
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, State of Vienna, 1090
Stefan J Schaller, MD, +4314040041020, stefan.schaller@meduniwien.ac.at
Study Coordinator, +4314040041020, aai-research@meduniwien.ac.at
About this study
Official title: Improved Muscle Metabolism by Combination of Muscle Activation and Protein Substitution: a Randomized, Outcome-assessor Blinded, Proof-of-concept Study (IMEMPRO)
Intensive Care Unit Acquired Weakness (ICUAW) describes muscle weakness that occurs in around 40% of patients during an intensive care stay. The morbidity and mortality of these patients is significantly increased over a 5-year period. The aim of this study is to investigate the combined effect of early enteral high-protein nutrition and early muscle activation on muscle atrophy in critically ill patients.
The study will include 40 patients (20 intervention, 20 observation) with requirement for enteral nutrition at time of inclusion. In the intervention group the maximum possible level of mobilization is carried out and muscles are activated twice a day using neuromuscular electrical stimulation (NMES). The nutrition plan of the intervention group is based on the applicable guidelines for intensive care medicine with exception of increased protein intake. The control group receives therapy without deviating from the standard according of the DGEM guideline.
The study aims to show that the decrease in muscle mass is significantly less than in the control group (primary hypothesis) via ultrasound of the rectus femoris muscle and in case of given consent muscle biopsy. As secondary hypothesis it is examined whether the combination of early high protein intake and muscle activation improves muscle strength and endurance.
Read the detailed description
Intensive Care Unit Acquired Weakness (ICUAW) describes the clinically diagnosed manifestation of a neuromuscular organ dysfunction. It develops in approximately 40% of all intensive care unit patients amounting to at least 1.2 million patients annually in Germany. All these patients face a broad range of sequeleae and an increased mortality up to 5 years after ICU discharge. A characteristic pathophysiological phenomenon is an early severe muscle atrophy reaching 10% during the first days after ICU admission.
The current preventative and therapeutic approach for ICUAW is a combination of targeted risk factor management as well as early activation of muscles, i.e. neuromuscular electrical stimulation (NMES) and early mobilization as they have been shown to counteract the muscle atrophy and mediate different outcome benefits such as shorter ICU stay.
Nutrition is a key element of our daily life. Protein intake has been shown to affect lean mass and muscle mass. Research into specific nutritional strategies to treat or prevent ICUAW are scarce and the combination with early muscle activation has not been adequately explored.
The study will include 40 patients (20 intervention, 20 observation) who were admitted to an intensive care unit within the last 48 hours. A basic requirement for inclusion is an indication for enteral (via the gastrointestinal tract) nutrition at time of inclusion. In the intervention group, the ability to mobilize is assessed daily and the maximum possible level of mobilization is carried out and additional muscles are activated twice a day using neuromuscular electrical stimulation (NMES). The nutrition plan of the intervention group is based on the applicable guidelines for intensive care medicine. In this study, protein intake is increased in the interventional group. The control group receives therapy without deviating from the standard according to the SOP and DGEM guideline: "Clinical nutrition in intensive care medicine" 2018.
The study aims to show that the decrease in muscle mass is significantly less than in the control group (primary hypothesis) via ultrasound of the rectus femoris muscle and muscle biopsy. As a second hypothesis it is examined whether the combination of early high protein intake and muscle activation improves muscle strength and endurance compared to the control group.
Further exploratory analyses will investigate changes in the skeletal muscle glycogen content, skeletal muscle histology, skeletal muscle gene expression, skeletal muscle protein level, as well as metabolomic changes in blood and urine.
An additional blood sample will be taken after 90 days as part of a follow-up.
- Conditions
- ICU Acquired Weakness, Muscle Atrophy, Energy Malnutrition Protein, Quality of Life, Morphological and Microscopic Findings, Metabolic Disturbance
- Being tested
- Dietary Supplement: additional substitution of protein, Neuromuscular electrical stimulation, Early Mobilization
- Keywords
- Early Mobilization and high-protein nutrition
- Medical subject headings
- Muscular Atrophy, Protein-Energy Malnutrition, Morphological and Microscopic Findings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Supplement: additional substitution of proteinDietary supplement
Day one (admission) no nutrition is applied.
Protein target is increased as follows:
- to a level of 1,2g/kg/d on day 1 after ICU admission
- to a level of 1,4g/kg/d on day 2 after ICU admission
- to a level of 1,6g/kg/d on day 3 after ICU admission
- to a level of 1,8g/kg/d on day 4 after ICU admission
- to a level of 2,0g/kg/d from day 5 onwoards
Additional protein is given within 2 hours after mobilization respectively:
- to 0,125g/kg/d on day 1 after ICU admission
- to 0,2g/kg/d on day 2 after ICU admission
- to 0,25g/kg/d on day 3 after ICU admission
- to 0,3g/kg/d from day 4 after ICU admission onwoards
Neuromuscular electrical stimulationDevice
twice daily 60 minutes till day 28 or ICU discharge
Early MobilizationOther
at least 20 minutes a day following the SOMS concept. Duration: till 28 day or ICU discharge
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | High protein substitution plus NMES and EM Receives: Dietary Supplement: Dietary Supplement: additional substitution of protein; Device: Neuromuscular electrical stimulation; Other: Early Mobilization |
| Control Group | No intervention | Nutrition and mobilization are carried out according to standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cross sectional area (ΔCSA) of the rectus femoris
Change in muscle mass between study inclusion and study day 14; measured as change of the cross sectional area (ΔCSA) of the rectus femoris muscle via ultrasound.
Measured: day 1 (study inclusion) and 14 days
Secondary outcomes (14)
change in muscle thickness of the rectus femoris
change in muscle thickness from study inclusion until 90-day follow-up, measured via ultrasound.
Measured: day 1 (study inclusion) until 90-day Follow-up
change in echogenicity of the rectus femoris
change in echogenicity from study inclusion until 90-day follow-up, measured via ultrasound.
Measured: day 1 (study inclusion) until 90-day Follow-up
change of the pennation angle of the rectus femoris
change of the pennation angle from study inclusion until 90-day follow-up, measured via ultrasound.
Measured: day 1 (study inclusion) until 90-day Follow-up
change of the muscle strength, measured by the Medical Research Council score (MRC-score)
change of the muscle strength, measured by the Medical Research Council score (MRC-score) from study inclusion until 90-day follow-up
Measured: day 1 (study inclusion) until 90-day Follow-up
change of the muscle strength, measured by handgrip dynamometry
change of the muscle strength, measured by handgrip dynamometry from study inclusion until 90-day follow-up
Measured: day 1 (study inclusion) until 90-day Follow-up
change in muscle endurance
change in muscle endurance, measured by the 6-minute walking test up to 90-day follow-up
Measured: up to 90 day follow up
change in physical physical function
change in physical physical function, measured by the Short Physical Performance Battery up to 90-day follow-up
Measured: up to 90-day follow-up
development of quality of life
development of quality of life, measured by the Short Form-36 up to 90-day follow-up
Measured: up to 90-day follow-up
change in Skeletal muscle mass
change in Skeletal muscle mass, measured with bioelectrical impedance analysis up to 90-day follow-up.
Measured: day 1 (study inclusion) until 90-day Follow-up
change in extracellular volume
change in extracellular volume, measured by the Body impedance analysis
Measured: day 1 (study inclusion) until 90-day Follow-up
change in the REE (Resting Energy Expenditure)
change in the REE (Resting Energy Expenditure), measured by indirect calorimetry
Measured: day 1 (study inclusion) until 90-day Follow-up
urea-to-creatinine ratio
urea-to-creatinine ratio from blood sample
Measured: day 1 (study inclusion) until 90-day Follow-up
Identify possible predictors of muscle wasting in urine metabolomics at ICU admission
Among the urine metabolomics that will be measured, identify metabolites or combinations of metabolites whose high or low concentration(s) at ICU admission associate(s) with the amount of muscle loss. These metabolites are candidate biomarkers that could be used to identify individuals at risk of large muscle wasting and may give further insights into the mechanisms of muscle wasting.
Measured: day 1 (study inclusion) until 90-day Follow-up
Identify possible predictors of muscle wasting in the blood metabolome at ICU admission
Among the blood metabolome that will be measured, identify metabolites or combinations of metabolites whose high or low concentration(s) at ICU admission associate(s) with the amount of muscle loss. These metabolites are candidate biomarkers that could be used to identify individuals at risk of large muscle wasting and may give further insights into the mechanisms of muscle wasting.
Measured: day 1 (study inclusion) until 90-day Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start27 Jun 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICU Acquired WeaknessStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Fresenius Kabi, University Medicine Greifswald, Berlin Institute of Health, Universitätsklinikum Ulm, Medical University of Vienna
- Responsible party
- Principal investigator, Prof. Dr. Stefan Schaller, MD, Medical University of Vienna
- Investigators
- Stefan J Schaller, MD, Principal investigator, Medical University of Vienna & Charité - Universitätsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05919940
- Sponsor's protocol ID
- IMEMPRO
- Status last verified
- Feb 2026
- First submitted
- 6 Jun 2023
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data can be requested on reasonable scientific request and data sharing contract, if necessary.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Muscle Metabolism by Combination of Muscle Activation and Protein Substitution: a Randomized, Outcome-assessor Blinded, Proof-of-concept Study (IMEMPRO)
- ClinicalTrials.gov ID
- NCT05919940
- Acronym / sponsor ID
- IMEMPRO
- Conditions
- ICU Acquired Weakness, Muscle Atrophy, Energy Malnutrition Protein, Quality of Life, Morphological and Microscopic Findings, Metabolic Disturbance
- Keywords
- Early Mobilization and high-protein nutrition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- Fresenius Kabi, University Medicine Greifswald, Berlin Institute of Health, Universitätsklinikum Ulm, Medical University of Vienna
- Study start
- 27 Jun 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 27 Jun 2023 (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.
Intensive Care Unit Acquired Weakness (ICUAW) describes muscle weakness that occurs in around 40% of patients during an intensive care stay. The morbidity and mortality of these patients is significantly increased over a 5-year period. The aim of this study is to investigate the combined effect of early enteral high-protein nutrition and early muscle activation on muscle atrophy in critically ill patients.
The study will include 40 patients (20 intervention, 20 observation) with requirement for enteral nutrition at time of inclusion. In the intervention group the maximum possible level of mobilization is carried out and muscles are activated twice a day using neuromuscular electrical stimulation (NMES). The nutrition plan of the intervention group is based on the applicable guidelines for intensive care medicine with exception of increased protein intake. The control group receives therapy without deviating from the standard according of the DGEM guideline.
The study aims to show that the decrease in muscle mass is significantly less than in the control group (primary hypothesis) via ultrasound of the rectus femoris muscle and in case of given consent muscle biopsy. As secondary hypothesis it is examined whether the combination of early high protein intake and muscle activation improves muscle strength and endurance.
Detailed description
Intensive Care Unit Acquired Weakness (ICUAW) describes the clinically diagnosed manifestation of a neuromuscular organ dysfunction. It develops in approximately 40% of all intensive care unit patients amounting to at least 1.2 million patients annually in Germany. All these patients face a broad range of sequeleae and an increased mortality up to 5 years after ICU discharge. A characteristic pathophysiological phenomenon is an early severe muscle atrophy reaching 10% during the first days after ICU admission.
The current preventative and therapeutic approach for ICUAW is a combination of targeted risk factor management as well as early activation of muscles, i.e. neuromuscular electrical stimulation (NMES) and early mobilization as they have been shown to counteract the muscle atrophy and mediate different outcome benefits such as shorter ICU stay.
Nutrition is a key element of our daily life. Protein intake has been shown to affect lean mass and muscle mass. Research into specific nutritional strategies to treat or prevent ICUAW are scarce and the combination with early muscle activation has not been adequately explored.
The study will include 40 patients (20 intervention, 20 observation) who were admitted to an intensive care unit within the last 48 hours. A basic requirement for inclusion is an indication for enteral (via the gastrointestinal tract) nutrition at time of inclusion. In the intervention group, the ability to mobilize is assessed daily and the maximum possible level of mobilization is carried out and additional muscles are activated twice a day using neuromuscular electrical stimulation (NMES). The nutrition plan of the intervention group is based on the applicable guidelines for intensive care medicine. In this study, protein intake is increased in the interventional group. The control group receives therapy without deviating from the standard according to the SOP and DGEM guideline: "Clinical nutrition in intensive care medicine" 2018.
The study aims to show that the decrease in muscle mass is significantly less than in the control group (primary hypothesis) via ultrasound of the rectus femoris muscle and muscle biopsy. As a second hypothesis it is examined whether the combination of early high protein intake and muscle activation improves muscle strength and endurance compared to the control group.
Further exploratory analyses will investigate changes in the skeletal muscle glycogen content, skeletal muscle histology, skeletal muscle gene expression, skeletal muscle protein level, as well as metabolomic changes in blood and urine.
An additional blood sample will be taken after 90 days as part of a follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Dietary Supplement: additional substitution of protein, Device: Neuromuscular electrical stimulation, Other: Early MobilizationHigh protein substitution plus NMES and EM |
| Control Group | No intervention | –Nutrition and mobilization are carried out according to standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- critically ill adults (≥ 18 years of age)
- newly admitted to the ICU (<48h)
- mechanically ventilated, expected to remain for at least 72h
- enteral nutrition is feasible
Key exclusion criteria (8 listed)
- a BMI > 30
- expected death or withdrawal of life-sustaining treatments
- prior neuromuscular disease (e.g. paresis, myopathies, neuropathies)
- injury or disease preventing neuromuscular electrical stimulation or early mobilization (e.g., elevated intracranial pressure, unstable spine)
- a pacemaker or other electronic implant
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 |
|---|---|---|
| Dietary Supplement: additional substitution of proteinDay one (admission) no nutrition is applied. Protein target is increased as follows: * to a level of 1,2g/kg/d on day 1 after ICU admission * to a level of 1,4g/kg/d on day 2 after ICU admission * to a level of 1,6g/kg/d on day 3 after ICU admission * to a level of 1,8g/kg/d on day 4 after ICU admission * to a level of 2,0g/kg/d from day 5 onwoards Additional protein is given within 2 hours after mobilization respectively: * to 0,125g/kg/d on day 1 after ICU admission * to 0,2g/kg/d on day 2 after ICU admission * to 0,25g/kg/d on day 3 after ICU admission * to 0,3g/kg/d from day 4 after ICU admission onwoards | Dietary supplement | Intervention |
| Neuromuscular electrical stimulationtwice daily 60 minutes till day 28 or ICU discharge | Device | Intervention |
| Early Mobilizationat least 20 minutes a day following the SOMS concept. Duration: till 28 day or ICU discharge | Other | Intervention |
Primary outcome
Change in cross sectional area (ΔCSA) of the rectus femoris
Time frame: day 1 (study inclusion) and 14 days
Change in muscle mass between study inclusion and study day 14; measured as change of the cross sectional area (ΔCSA) of the rectus femoris muscle via ultrasound.
14 secondary outcomes
change in muscle thickness of the rectus femoris
Time frame: day 1 (study inclusion) until 90-day Follow-up
change in echogenicity of the rectus femoris
Time frame: day 1 (study inclusion) until 90-day Follow-up
change of the pennation angle of the rectus femoris
Time frame: day 1 (study inclusion) until 90-day Follow-up
change of the muscle strength, measured by the Medical Research Council score (MRC-score)
Time frame: day 1 (study inclusion) until 90-day Follow-up
change of the muscle strength, measured by handgrip dynamometry
Time frame: day 1 (study inclusion) until 90-day Follow-up
change in muscle endurance
Time frame: up to 90 day follow up
change in physical physical function
Time frame: up to 90-day follow-up
development of quality of life
Time frame: up to 90-day follow-up
change in Skeletal muscle mass
Time frame: day 1 (study inclusion) until 90-day Follow-up
change in extracellular volume
Time frame: day 1 (study inclusion) until 90-day Follow-up
change in the REE (Resting Energy Expenditure)
Time frame: day 1 (study inclusion) until 90-day Follow-up
urea-to-creatinine ratio
Time frame: day 1 (study inclusion) until 90-day Follow-up
Identify possible predictors of muscle wasting in urine metabolomics at ICU admission
Time frame: day 1 (study inclusion) until 90-day Follow-up
Identify possible predictors of muscle wasting in the blood metabolome at ICU admission
Time frame: day 1 (study inclusion) until 90-day Follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: Yes. Deidentified data can be requested on reasonable scientific request and data sharing contract, if necessary.
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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.
Marian Demitsch contact
Stefan J Schaller, MD principal investigator
Medical University of Vienna & Charité - Universitätsmedizin Berlin
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Supplement: additional substitution of protein, Neuromuscular electrical stimulation and Early Mobilization in people with ICU Acquired Weakness and Muscle Atrophy, run by Technical University of Munich at 4 sites in 2 countries.
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 4 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: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Austria. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefan J Schaller, MD (+498941409635, s.schaller@tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cross sectional area (ΔCSA) of the rectus femoris (time frame: day 1 (study inclusion) and 14 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 3 Mar 2026.