CYCLE Pilot (Critical Care Cycling to Improve Lower Extremity Strength): A Pilot Randomized Study of Early Cycle Ergometry versus Routine Physiotherapy in Mechanically Ventilated Patients
Background: Patients in the intensive care unit (ICU) are the sickest in hospital, and need advanced life-support. Survivors of critical illness are very vulnerable to weakness and disability. Up to 1 in 4 have severe leg weakness impairing their quality of life for as long as 5 years after ICU discharge. In-bed cycling employs special equipment that attaches to a patient’s hospital bed, allowing them gentle leg exercise while in the ICU. We will offer patients in-bed cycling while they are needing a breathing machine, to help them recover from weakness as fast as possible. Before doing a larger trial testing if in-bed cycling reduces disability, data on feasibility (Can we do it?) are needed.
Objectives: To study the feasibility of conducting a future multi-centre randomized clinical trial of in-bed leg cycling and routine physiotherapy versus routine physiotherapy alone in critically ill patients who need breathing machines.
Methods: Adult patients admitted to the ICU who need a breathing machine and are expected to survive their ICU stay are eligible. Patients will be randomized to receive 30 minutes of in-bed cycling each day while they are in the ICU and routine physiotherapy or routine physiotherapy alone. Specially trained physiotherapists will deliver both interventions.
Outcomes: We will study feasibility: whether patients can cycle on most days of their ICU stay, whether patients and their families agree to be a part of the study, and whether we can assess patients’ strength in the ICU and at hospital discharge.
Relevance: As the Canadian population ages, the demand for breathing machines during acute illness will increase dramatically. Effective methods of physiotherapy are needed for critically ill patients to minimize muscle weakness, speed recovery, and improve quality of life. This pilot study is the second of several future larger studies about in-bed cycling in the ICU. This program of research will help patients needing life support to regain their strength and recover as fast as possible from critical illness.