Effect of In-Bed Leg Cycling and Electrical Stimulation of the Quadriceps on Global Muscle Strength in Critically Ill Adults: A Randomized Clinical Trial

• Published in: JAMA : the journal of the American Medical Association Vol. 320; no. 4; pp. 368 - 378
• Main Authors: Fossat, Guillaume, Baudin, Florian, Courtes, Léa, Bobet, Sabrine, Dupont, Arnaud, Bretagnol, Anne, Benzekri-Lefèvre, Dalila, Kamel, Toufik, Muller, Grégoire, Bercault, Nicolas, Barbier, François, Runge, Isabelle, Nay, Mai-Anh, Skarzynski, Marie, Mathonnet, Armelle, Boulain, Thierry
• Format: Journal Article
• Language: English
• Published: United States American Medical Association 24-07-2018
• Subjects: Adult; Adults; Aged; Autonomy; Clinical significance; Clinical trials; Critical Care; Critical Illness - rehabilitation; Cycles; Electric Stimulation; Electrical stimuli; Evaluation; Exercise Therapy; Female; Humans; Intensive Care Units; Intervention; Leg; Male; Mechanical ventilation; Medical research; Medical treatment; Metabolic disorders; Middle Aged; Mobility; Muscle recovery; Muscle Strength; Muscles; Patients; Preliminary Communication; Quadriceps muscle; Quadriceps Muscle - physiology; Quality assessment; Quality of life; Rehabilitation; Rehabilitation - methods; Stimulation; Ventilation; Walking; Walking - physiology
• ISSN: 0098-7484; 1538-3598
• DOI: 10.1001/jama.2018.9592

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. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02185989