IMPORTANCE Early in-bed cycling and electrical muscle stimulation may improve the benefits of rehabilitation in patients in the intensive care unit (ICU). OBJECTIVE To investigate whether early in-bed leg cycling plus electrical stimulation of the quadriceps muscles added to standardized early rehabilitation would result in greater muscle strength at discharge from the ICU. DESIGN, SETTING, AND PARTICIPANTS Single-center, randomized clinical trial enrolling critically ill adult patients at 1 ICU within an 1100-bed hospital in France. Enrollment lasted from July 2014 to June 2016 and there was a 6-month follow-up, which ended on November 24, 2016. INTERVENTIONS Patients were randomized to early in-bed leg cycling plus electrical stimulation of the quadriceps muscles added to standardized early rehabilitation (n = 159) or standardized early rehabilitation alone (usual care) (n = 155). MAIN OUTCOMES AND MEASURES The primary outcome was muscle strength at discharge from the ICU assessed by physiotherapists blinded to treatment group using the Medical Research Council grading system (score range, 0-60 points; a higher score reflects better muscle strength; minimal clinically important difference of 4 points). Secondary outcomes at ICU discharge included the number of ventilator-free days and ICU Mobility Scale score (range, 0-10; a higher score reflects better walking capability). Functional autonomy and health-related quality of life were assessed at 6 months. RESULTS Among 314 randomized patients, 312 (mean age, 66 years; women, 36%; receiving mechanical ventilation at study inclusion, 78%) completed the study and were included in the analysis. The median global Medical Research Council score at ICU discharge was 48 (interquartile range [IQR], 29 to 58) in the intervention group and 51 (IQR, 37 to 58) in the usual care group (median difference, −3.0 [95% CI, −7.0 to 2.8]; P = .28). The ICU Mobility Scale score at ICU discharge was 6 (IQR, 3 to 9) in both groups (median difference, 0 [95% CI, −1 to 2]; P = .52). The median number of ventilator-free days at day 28 was 21 (IQR, 6 to 25) in the intervention group and 22 (IQR, 10 to 25) in the usual care group (median difference, 1 [95% CI, −2 to 3]; P = .24). Clinically significant events occurred during mobilization sessions in 7 patients (4.4%) in the intervention group and in 9 patients (5.8%) in the usual care group. There were no significant between-group differences in the outcomes assessed at 6 months. CONCLUSIONS AND RELEVANCE In this single-center randomized clinical trial involving patients admitted to the ICU, adding early in-bed leg cycling exercises and electrical stimulation of the quadriceps muscles to a standardized early rehabilitation program did not improve global muscle strength at discharge from the ICU.
Background
Few studies have evaluated muscle strength in COVID-19 ICU survivors. We aimed to report the incidence of limb and respiratory muscle weakness in COVID-19 ICU survivors.
Method
We performed a cross sectional study in two ICU tertiary Hospital Settings. COVID-19 ICU survivors were screened and respiratory and limb muscle strength were measured at the time of extubation. An ICU mobility scale was performed at ICU discharge and walking capacity was self-evaluated by patients 30 days after weaning from mechanical ventilation.
Results
Twenty-three patients were included. Sixteen (69%) had limb muscle weakness and 6 (26%) had overlap limb and respiratory muscle weakness. Amount of physiotherapy was not associated with muscle strength. 44% of patients with limb weakness were unable to walk 100 m 30 days after weaning.
Conclusion
The large majority of COVID-19 ICU survivors developed ICU acquired limb muscle weakness. 44% of patients with limb weakness still had severely limited function one-month post weaning.
IntroductionCOVID-19 is responsible of severe hypoxaemia and acute respiratory distress syndrome (ARDS). Prone positioning improves oxygenation and survival in sedated mechanically patients with ARDS not related to COVID-19. Awake prone positioning is a simple and safe technique which improves oxygenation in non-intubated COVID-19 patients. We hypothesised that early prone positioning in COVID-19 patients breathing spontaneously in medical wards could decrease the rates of intubation or need for noninvasive ventilation or death.Methods and analysisPROVID-19 is an investigator-initiated, prospective, multicentre randomised, controlled, superiority trial comparing awake prone positioning to standard of care in hypoxaemic COVID-19 patients in 20 medical wards in France and Monaco. Patients are randomised to receive either awake prone position plus usual care or usual care alone with stratification on centres, body mass index and severity of hypoxaemia.The study objective is to compare the rate of treatment failure defined as a composite endpoint comprising the need for non-invasive ventilation (at two pressure levels) or for intubation or death, between the intervention group (awake prone position plus usual care) and the usual care (usual care alone) group at 28 days.Ethics and disseminationThe protocol and amendments have been approved by the ethics committees (Comité de protection des personnes Ouest VI, France, no 1279 HPS2 and Comité Consultatif d’Ethique en matière de Recherche Biomédicale, Monaco, no 2020.8894 AP/jv), and patients are included after written informed consent. The results will be submitted for publication in peer-reviewed journals.Trial registration numberNCT04363463.
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