Franz Alexander, Wolf Katharina Friederike, Behrens Julika, Koos Björn, Adamzik Michael, Ehrentraut Stefan Felix
Department of Orthopedics and Trauma Surgery, University Hospital Bonn, Venusberg-Campus 1, Bonn, 53127 , Germany.
Department of Trauma and Orthopedic Surgery, BG Klinik Ludwigshafen, Ludwigshafen, Germany.
Trials. 2025 Jun 1;26(1):182. doi: 10.1186/s13063-025-08874-y.
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.
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.
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.
ClinicalTrials.gov DRKS00033592. Registered on March 05, 2024.
重症监护病房获得性肌无力（ICUAW）是危重症患者中一种常见的继发性疾病，其特征是肌肉质量和力量显著丧失，常导致重症监护病房住院时间延长、死亡率增加以及出院后生活质量下降。尽管指南推荐早期活动，但后勤方面的挑战以及疗效不明确限制了其对ICUAW患病率的影响。本研究旨在评估单纯被动物理治疗干预措施的可行性、安全性和临床疗效，这些干预措施包括血流限制/缺血预处理（BFR/IPC）和肌电刺激（EStim），作为经常接受镇静或无法参与主动康复的ICU患者肌肉保护的潜在替代方法。
这项前瞻性随机对照试验将从波恩大学医院外科重症监护病房招募120名符合入住重症监护病房超过48小时纳入标准的患者。患者将被随机分为四组：假对照、BFR/IPC、EStim以及联合BFR/IPC + EStim。该研究的主要终点包括可行性和安全性指标，如患者依从性和应激反应，以及与临床结局相关的次要终点，如重症监护病房住院时间、ICUAW患病率、肌肉质量维持和康复疗效。测量包括肌肉质量的非侵入性评估、用于监测代谢和炎症标志物的肌内微透析，以及出院后的健康相关生活质量评估。
初步文献和系统评价强调了在重症监护病房环境中需要资源高效、非侵入性的干预措施。BFR/IPC和EStim呈现出有前景的结果，但关于它们在ICU人群中疗效的现有数据有限。本研究的结果将为被动物理治疗技术在重症监护病房环境中的可行性提供基础数据，有可能改善患者结局并降低与重症监护病房住院时间延长相关的医疗成本。如果成功，这些结果将为多中心随机试验提供信息，以进一步评估这些干预措施。这项研究是制定可行的康复方案以减轻ICUAW的关键一步，解决了重症监护管理和康复中的一个关键差距。
ClinicalTrials.gov DRKS00033592。于2024年3月5日注册。
