Clinical trial Recruiting at 2 sites Interventional Ages 18 and up

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.

More Muscle Atrophy trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment40 (estimated)
SponsorTechnical University of Munich
Academic / other
Locations4 sites (Vienna, State of Vienna and 3 other locations)
StatusRecruiting
StartedJune 27, 2023
Main results expectedDecember 31, 2026
Study endsJanuary 31, 2027
Registry record updatedMarch 3, 2026
Trial IDNCT05919940 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.