Combining muscle activation and high-protein nutrition to improve muscle health in ICU patients
Improved Muscle Metabolism by Combination of Muscle Activation and Protein Substitution: a Randomized, Outcome-assessor Blinded, Proof-of-concept Study (IMEMPRO)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Technical University of Munich Academic / other |
| Locations | 4 sites (Vienna, State of Vienna and 3 other locations) |
| Trial ID | NCT05919940 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Vienna, State of Vienna and 3 other locations
- Medical University of Vienna — Vienna, State of Vienna, Austria (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)
- Universitätsklinikum Ulm — Ulm, Germany (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.