The effect of passive mobilization associated with blood flow restriction and combined with electrical stimulation on cardiorespiratory safety, neuromuscular adaptations, physical function, and quality of life in comatose patients in an ICU: a randomized controlled clinical trial

Trials

Naiara Garcia Molina¹  Tamara Rodrigues da Silva Destro¹  Thaís Marina Pires de Campos Biazon¹  Flávia Rossi Caruso¹  Audrey Borghi-Silva¹  Renata Gonçalves Mendes¹  Jose Carlos Bonjorno Junior²  Cleiton Augusto Libardi³ 

[1] 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;Department of Medicine, Federal University of São Carlos, São Carlos, Brazil;Department of Anesthesiology and Intensive Care Unit at the Irmandade da Santa Casa de Misericórdia de São Carlos, São Carlos, Brazil;Laboratory of Neuromuscular Adaptations to Resistance Training, Department of Physical Education, Federal University of São Carlos, São Carlos, Brazil;

关键词: Blood flow restriction;    Electrical stimulation;    Cardiorespiratory safety;    Intensive care unit-acquired atrophy;    Intensive care unit-acquired weakness;    Neuromuscular adaptations;    Physical function;    Quality of life;    Critical care;   

DOI  :  10.1186/s13063-021-05916-z

来源: Springer

【 摘 要 】

BackgroundIntensive 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).MethodsThirty-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.DiscussionIn 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.Trial registrationUniversal 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/

【 授权许可】

CC BY