Early rehabilitation using a passive cycle ergometer on muscle morphology in mechanically ventilated critically ill patients in the Intensive Care Unit (MoVe-ICU study) : study protocol for a randomized controlled trial

Background: Patients in Intensive Care Units (ICU) are often exposed to prolonged immobilization which, in turn, plays an important role in neuromuscular complications. Exercise with a cycle ergometer is a treatment option that can be used to improve the rehabilitation of patients on mechanical ventilation (MV) in order to minimize the harmful effects of immobility. Methods/Design: A single-blind randomized controlled trial (the MoVe ICU study) will be conducted to evaluate and compare the effects of early rehabilitation using a bedside cycle ergometer with conventional physical therapy on the muscle morphology of the knee extensors and diaphragm in critical ill patients receiving MV. A total of 28 adult patients will be recruited for this study from among those admitted to the intensive care department at the Hospital de Clínicas de Porto Alegre. Eligible patients will be treated with MV from a period of 24 to 48 h, will have spent maximum of 1 week in hospital and will not exhibit any characteristics restricting lower extremity mobility. These subjects will be randomized to receive either conventional physiotherapy or conventional physiotherapy with an additional cycle ergometer intervention. The intervention will be administered passively for 20 min, at 20 revolutions per minute (rpm), once per day, 7 days a week, throughout the time the patients remain on MV. Outcomes will be cross-sectional quadriceps thickness, length of fascicle, pennation angle of fascicles, thickness of vastus lateralis muscle, diaphragm thickness and excursion of critical ICU patients on MV measured with ultrasound. Discussion: The MoVe-ICU study will be the first randomized controlled trial to test the hypothesis that early rehabilitation with a passive cycle ergometer can preserve the morphology of knee extensors and diaphragm in critical patients on MV in ICUs. Trial registration: NCT02300662 (25 November 2014)