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 1,100-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 to 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 to 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 = 0.28). 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 = 0.52). 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 = 0.24). 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. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02185989.

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