NCT05919940 Improved Muscle Metabolism by Combination of Muscle Activation and Protein Substitution ( IMEMPRO )
| NCT ID | NCT05919940 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Technical University of Munich |
| Condition | ICU Acquired Weakness |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-06-27 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2023-06-27 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility 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
Contact & Investigator
Stefan J Schaller, MD
PRINCIPAL INVESTIGATOR
Medical University of Vienna & Charité - Universitätsmedizin Berlin
Frequently Asked Questions
Who can join the NCT05919940 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying ICU Acquired Weakness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05919940 currently recruiting?
Yes, NCT05919940 is actively recruiting participants. Contact the research team at s.schaller@tum.de for enrollment information.
Where is the NCT05919940 trial being conducted?
This trial is being conducted at Vienna, Austria, Munich, Germany, Berlin, Germany, Ulm, Germany.
Who is sponsoring the NCT05919940 clinical trial?
NCT05919940 is sponsored by Technical University of Munich. The principal investigator is Stefan J Schaller, MD at Medical University of Vienna & Charité - Universitätsmedizin Berlin. The trial plans to enroll 40 participants.