Safety and effects of early mobilization with in-bed cycloergometry versus conventional physiotherapy in critically ill patients: A randomized control trial.

OBJECTIVE: To compare the safety of conventional physiotherapy alone versus its combination with cycloergometry by analysing session interruptions and physiological tolerance in critically ill patients. Secondarily, efficacy was assessed through strength and functional related outcomes. DESIGN: Single-centre, parallel, two-arm, randomized clinical trial. SETTING: Intensive Care Department. PARTICIPANTS: Mechanically ventilated patients. INTERVENTION: Control group received 30-min of conventional physiotherapy; intervention group received 15-min of cycloergometry and 15-min of conventional physiotherapy. MAIN VARIABLES OF INTEREST: and tidal volume before and after sessions. Muscle strength (modified Medical Research Council score, quadriceps and handgrip strength) was evaluated at first cooperation of participants, ICU discharge, 28-day and 6-month follow-up; Activities of Daily Living score and mobility scale at ICU discharge, 28 days and 6 months; and six-minute walking test and Short Form-36 at 28 days and 6 months. RESULTS: 46 participants completed 732 sessions. Both interventions produced significant but comparable physiological changes. Cycloergometry sessions were longer (30 vs. 25 min, p < 0.001) and had more interruptions (13% vs. 7%, p = 0.008), mainly due to fatigue and lack of cooperation. With the applied methodology no significant differences were observed in muscle strength or functional outcomes at any time point. CONCLUSION: Partially replacing conventional physiotherapy with cycloergometry was safe and well tolerated in critically ill patients. However, due to methodological limitations and the small sample size, no firm conclusions regarding efficacy can be drawn.