Cardiopulmonary Physical Therapy Laboratory, Department of Physical Therapy, Federal University of São Carlos, Rod. Washington Luiz, km 235 - SP 310, CEP 13565-905, São Carlos, Brazil.
Laboratory of Neuromuscular Adaptations to Resistance Training, Department of Physical Education, Federal University of São Carlos, São Carlos, Brazil.
Trials. 2021 Dec 30;22(1):969. doi: 10.1186/s13063-021-05916-z.
Intensive care unit-acquired atrophy and weakness are associated with high mortality, a reduction in physical function, and quality of life. Passive mobilization (PM) and neuromuscular electrical stimulation were applied in comatose patients; however, evidence is inconclusive regarding atrophy and weakness prevention. Blood flow restriction (BFR) associated with PM (BFRp) or with electrical stimulation (BFRpE) was able to reduce atrophy and increase muscle mass in spinal cord-injured patients, respectively. Bulky venous return occurs after releasing BFR, which can cause unknown repercussions on the cardiovascular system. Hence, the aim of this study was to investigate the effect of BFRp and BFRpE on cardiovascular safety and applicability, neuromuscular adaptations, physical function, and quality of life in comatose patients in intensive care units (ICUs).
Thirty-nine patients will be assessed at baseline (T0-18 h of coma) and randomly assigned to the PM (control group), BFRp, or BFRpE groups. The training protocol will be applied in both legs alternately, twice a day with a 4-h interval until coma awake, death, or ICU discharge. Cardiovascular safety and applicability will be evaluated at the first training session (T1). At T0 and 12 h after the last session (T2), muscle thickness and quality will be assessed. Global muscle strength and physical function will be assessed 12 h after T2 and ICU and hospital discharge for those who wake up from coma. Six and 12 months after hospital discharge, physical function and quality of life will be re-assessed.
In view of applicability, the data will be used to inform the design and sample size of a prospective trial to clarify the effect of BFRpE on preventing muscle atrophy and weakness and to exert the greatest beneficial effects on physical function and quality of life compared to BFRp in comatose patients in the ICU.
Universal Trial Number (UTN) Registry UTN U1111-1241-4344. Retrospectively registered on 2 October 2019. Brazilian Clinical Trials Registry (ReBec) RBR-2qpyxf . Retrospectively registered on 21 January 2020, http://ensaiosclinicos.gov.br/rg/RBR-2qpyxf/.
重症监护病房获得性萎缩和无力与高死亡率、身体功能下降和生活质量降低有关。被动运动（PM）和神经肌肉电刺激已应用于昏迷患者；然而，关于预防萎缩和无力的证据尚无定论。血流限制（BFR）与 PM（BFRp）或电刺激（BFRpE）联合应用可分别减少脊髓损伤患者的萎缩并增加肌肉量。释放 BFR 后会出现大量静脉回流，这可能对心血管系统造成未知的影响。因此，本研究旨在探讨 BFRp 和 BFRpE 对 ICU 昏迷患者心血管安全性和适用性、神经肌肉适应性、身体功能和生活质量的影响。
39 名患者将在基线（昏迷后 18 小时内）进行评估，并随机分配到 PM（对照组）、BFRp 或 BFRpE 组。训练方案将在两腿之间交替进行，每天两次，间隔 4 小时，直到昏迷清醒、死亡或 ICU 出院。在第一次训练课程（T1）时评估心血管安全性和适用性。在 T0 和最后一次训练课程后 12 小时（T2）评估肌肉厚度和质量。在 T2 后 12 小时和昏迷患者苏醒后 ICU 和医院出院时评估全身肌肉力量和身体功能。出院后 6 个月和 12 个月，重新评估身体功能和生活质量。
鉴于适用性，数据将用于为前瞻性试验的设计和样本量提供信息，以阐明 BFRpE 对预防肌肉萎缩和无力的影响，并与 ICU 昏迷患者的 BFRp 相比，对身体功能和生活质量产生最大的有益影响。
通用试验编号（UTN）注册表 UTN U1111-1241-4344。于 2019 年 10 月 2 日回顾性注册。巴西临床试验注册处（ReBec）RBR-2qpyxf. 于 2020 年 1 月 21 日回顾性注册，http://ensaiosclinicos.gov.br/rg/RBR-2qpyxf/。
