Biomedical Research Institute, Seoul National University Hospital, Seoul, South Korea.
Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, South Korea.
PLoS One. 2024 May 10;19(5):e0301368. doi: 10.1371/journal.pone.0301368. eCollection 2024.
Intensive care unit (ICU)-acquired weakness (ICU-AW) is one of the most common complications of post-ICU syndrome. It is the leading cause of gait disturbance, decreased activities of daily living, and poor health-related quality of life. The early rehabilitation of critically ill patients can reduce the ICU-AW. We designed a protocol to investigate the feasibility and safety of conventional rehabilitation with additional in-bed cycling/stepping in critically ill patients.
The study is designed as a single-center, single-blind, pilot, randomized, parallel-group study. After the screening, participants are randomly allocated to two groups, stratified by mechanical ventilation status. The intervention group will be provided with exercises of in-bed cycling/stepping according to the level of consciousness, motor power, and function in addition to conventional rehabilitation. In contrast, the control group will be provided with only conventional rehabilitation. The length of intervention is from ICU admission to discharge, and interventions will be conducted for 20 minutes, a maximum of three sessions per day.
The outcomes are the number and percentage of completed in-bed cycling/stepping sessions, the duration and percentage of in-bed cycling/stepping sessions, and the number of cessations of in-bed cycling/stepping sessions, the interval from ICU admission to the first session of in-bed cycling/stepping, the number and percentage of completed conventional rehabilitation sessions, the duration and percentage of conventional rehabilitation sessions, the number of cessations of conventional rehabilitation sessions, the number of adverse events, level of consciousness, functional mobility, muscle strength, activities of daily living, and quality of life.
This study is a pilot clinical trial to investigate the feasibility and safety of conventional rehabilitation with additional in-bed cycling/stepping in critically ill patients. If the expected results are achieved in this study, the methods of ICU rehabilitation will be enriched.
clinicialtrials.gov, Clinical Trials Registration #NCT05868070.
重症监护病房获得性肌无力（ICU-AW）是 ICU 后综合征最常见的并发症之一。它是导致步态障碍、日常生活活动减少和健康相关生活质量下降的主要原因。对危重症患者进行早期康复可以减少 ICU-AW。我们设计了一项方案，旨在研究对危重症患者进行常规康复治疗基础上增加床上踏车/踏步训练的可行性和安全性。
该研究设计为单中心、单盲、先导、随机、平行组研究。筛选后，参与者按照机械通气状态分层随机分配至两组。干预组将在常规康复治疗的基础上，根据意识水平、运动力量和功能，进行床上踏车/踏步运动。相比之下，对照组将仅接受常规康复治疗。干预时间从 ICU 入院到出院，干预每天最多进行 3 次，每次 20 分钟。
主要结局指标为完成床上踏车/踏步训练的次数和比例、床上踏车/踏步训练的持续时间和比例、床上踏车/踏步训练的停止次数、从 ICU 入院到开始第一次床上踏车/踏步训练的时间、完成常规康复治疗的次数和比例、常规康复治疗的持续时间和比例、常规康复治疗的停止次数、不良事件的发生数量、意识水平、功能性移动能力、肌肉力量、日常生活活动能力和生活质量。
本研究是一项探索对危重症患者进行常规康复治疗基础上增加床上踏车/踏步训练的可行性和安全性的先导性临床试验。如果本研究达到预期结果，将丰富 ICU 康复治疗方法。
ClinicalTrials.gov，临床试验注册号 NCT05868070。
