Journal Article

Effects of passive blood-flow-restriction and electromyostimulation on ICU-acquired weakness (ICUAW): a study protocol for a randomized-controlled, parallel-group clinical trial

Koos, Björn, Franz, Alexander, Ehrentraut, Stefan Felix, Wolf, Katharina Friederike, Behrens, Julika, Adamzik, Michael

2025

Overview

Background Intensive care unit-acquired weakness (ICUAW) is a prevalent secondary disorder in critically ill patients, characterized by significant loss of muscle mass and strength, often leading to prolonged ICU stays, increased mortality, and reduced post-discharge quality of life. Despite guidelines recommending early mobilization, logistical challenges and inconclusive efficacy have limited its impact on ICUAW prevalence. This study aims to assess the feasibility, safety, and clinical efficacy of exclusively passive physiotherapeutic interventions, including blood flow restriction/ischemic preconditioning (BFR/IPC) and electromyostimulation (EStim), as potential alternatives for muscle preservation in ICU patients who are often sedated or unable to participate in active rehabilitation. Methods This prospective, randomized controlled trial will recruit 120 patients from the surgical ICU at the University Hospital Bonn, who meet the inclusion criteria of a > 48-h ICU stay. Patients will be randomized into four groups: Sham-Control, BFR/IPC, EStim, and combined BFR/IPC + EStim. The study’s primary endpoints include feasibility and safety metrics, such as patient compliance and stress response, alongside secondary endpoints related to clinical outcomes like ICU length of stay, ICUAW prevalence, muscle mass preservation, and rehabilitation efficacy. Measurements include non-invasive assessments of muscle mass, intramuscular microdialysis to monitor metabolic and inflammatory markers, and health-related quality of life evaluations post-discharge. Discussion Preliminary literature and a systematic review underscore the need for resource-efficient, non-invasive interventions in ICU settings. BFR/IPC and EStim present promising results, but existing data on their efficacy in ICU populations are limited. This study’s findings will provide foundational data on the viability of passive physiotherapy techniques in ICU settings, potentially improving patient outcomes and reducing healthcare costs associated with prolonged ICU stays. If successful, these results will inform a multicenter randomized trial to further evaluate these interventions. This research represents a crucial step in developing feasible rehabilitation protocols to mitigate ICUAW, addressing a critical gap in critical care management and rehabilitation. Trial registration ClinicalTrials.gov DRKS00033592. Registered on March 05, 2024.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Atrophy / Biomedicine / Blood flow restriction (BFR) / Critical Illness - rehabilitation / Electric Stimulation Therapy - adverse effects / Electric Stimulation Therapy - methods / Electromyostimulation (EStim) / Exercise / Feasibility Studies / Health aspects / Health Sciences / Hospital patients / Hospitals / Humans / ICU-acquired weakness (ICUAW) / Illnesses / Intensive care / Intensive care unit (ICU) interventions / Intensive Care Units / Intubation / Ischemia / Ischemic Preconditioning - adverse effects / Ischemic Preconditioning - methods / Medicine / Medicine & Public Health / Meta-analysis / Metabolism / Mortality / Muscle atrophy prevention / Muscle Strength / Muscle Weakness - etiology / Muscle Weakness - physiopathology / Muscle Weakness - rehabilitation / Muscle Weakness - therapy / Muscle, Skeletal - blood supply / Muscle, Skeletal - physiopathology / Neuromuscular electrical stimulation / Patient compliance / Patient safety / Physical fitness / Physical therapy / Physical Therapy Modalities / Prospective Studies / Quality of Life / Randomized Controlled Trials as Topic / Regional Blood Flow / Rehabilitation / Statistics for Life Sciences / Study Protocol / Treatment Outcome