Combining muscle activation and high-protein nutrition to improve muscle health in ICU patients
Official title: Improved Muscle Metabolism by Combination of Muscle Activation and Protein Substitution: a Randomized, Outcome-assessor Blinded, Proof-of-concept Study (IMEMPRO)
Run by Technical University of Munich · NCT05919940 · Data updated 2026-11-12
This study is testing if giving high-protein nutrition along with muscle activation exercises can help critically ill patients in the ICU keep their muscles strong and recover better.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Technical University of Munich Academic / other |
| Locations | 4 sites (Vienna, State of Vienna and 3 other locations) |
| Status | Recruiting |
| Started | June 27, 2023 |
| Main results expected | December 31, 2026 |
| Study ends | January 31, 2027 |
| Registry record updated | March 3, 2026 |
| Trial ID | NCT05919940 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are critically ill adults aged 18 and older, newly admitted to the ICU within the last 48 hours, and requiring enteral nutrition.
✕Probably not a fit
Patients with a BMI over 30, prior neuromuscular diseases, or those expected to die or withdraw life-sustaining treatments may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effects of early enteral high-protein nutrition combined with early muscle activation on muscle atrophy in critically ill patients suffering from ICU Acquired Weakness (ICUAW). It will enroll 40 patients who require enteral nutrition and will be divided into two groups: one receiving enhanced protein intake and neuromuscular electrical stimulation (NMES) alongside mobilization, and the other receiving standard care. The aim is to assess whether this combined approach can mitigate muscle atrophy and improve patient outcomes during and after their ICU stay.
Why it matters
Potential benefit: If successful, this approach could significantly reduce muscle atrophy and improve recovery outcomes for critically ill patients.
How similar studies have gone: While the combination of early mobilization and high-protein nutrition has been explored separately, this specific approach is novel and has not been adequately tested in previous studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where it's running
-
Medical University of Vienna
Vienna, State of Vienna, Austria Recruiting -
Universitätsklinikum Ulm
Ulm, Germany Recruiting -
Klinikum rechts der Isar, School of Medicine, Technical Universtity of Munich
Munich, Bavaria, Germany Active not recruiting -
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, Germany Active not recruiting
Study contacts
- Principal investigator: Stefan J Schaller, MD — Medical University of Vienna & Charité - Universitätsmedizin Berlin
- Study coordinator: Stefan J Schaller, MD
- Email: s.schaller@tum.de
- Phone: +498941409635
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.