Improved Muscle Metabolism by Combination of Muscle Activation and Protein Substitution ( IMEMPRO )

NCT05919940 | Recruiting DMC

• 1 other identifier: IMEMPRO
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 4

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  day 1 (study inclusion) and 14 days

Secondary Outcomes (14)

• change in muscle thickness of the rectus femoris

  day 1 (study inclusion) until 90-day Follow-up

• change in echogenicity of the rectus femoris

  day 1 (study inclusion) until 90-day Follow-up

• change of the pennation angle of the rectus femoris

  day 1 (study inclusion) until 90-day Follow-up

• change of the muscle strength, measured by the Medical Research Council score (MRC-score)

  day 1 (study inclusion) until 90-day Follow-up

• change of the muscle strength, measured by handgrip dynamometry

  day 1 (study inclusion) until 90-day Follow-up

Other Outcomes (10)

• in-hospital mortality

  until 90-day Follow-up

• Hospital LOS

  until 90-day Follow-up

• ICU-LOS

  until 90-day Follow-up

Study Arms (2)

Intervention

EXPERIMENTAL

High protein substitution plus NMES and EM

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.

Interventions

Dietary Supplement: additional substitution of protein DIETARY_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

Intervention

Neuromuscular electrical stimulation DEVICE

twice daily 60 minutes till day 28 or ICU discharge

Intervention

Early Mobilization OTHER

at least 20 minutes a day following the SOMS concept. Duration: till 28 day or ICU discharge

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medicine Greifswald: collaborator
• Berlin Institute of Health: collaborator
• Universitätsklinikum Ulm: collaborator
• Medical University of Vienna: collaborator
• Technical University of Munich: lead
• Fresenius Kabi: collaborator

Study Sites (4)

Medical University of Vienna

Vienna, Vienna, 1090, Austria

RECRUITING

Klinikum rechts der Isar, School of Medicine, Technical Universtity of Munich

Munich, Bavaria, 81675, Germany

ACTIVE NOT RECRUITING

Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

ACTIVE NOT RECRUITING

Universitätsklinikum Ulm

Ulm, 89070, Germany

RECRUITING

MeSH Terms

Conditions

Muscular Atrophy; Protein-Energy Malnutrition; Morphological and Microscopic Findings

Interventions

Early Ambulation

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Protein Deficiency; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Stefan J Schaller, MD

  Medical University of Vienna & Charité - Universitätsmedizin Berlin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan J Schaller, MD

CONTACT

+498941409635; s.schaller@tum.de

Marian Demitsch

CONTACT

aai-research@muv.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 27, 2023
• Study Start: June 27, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After publication of scientific manuscript.
• Access Criteria: Deidentified data can be requested on reasonable scientific request and data sharing contract, if necessary.

Locations

AU (1); DE (3)