Respiratory Failure Clinical Trial
Official title:
TryCYCLE (Critical Care Cycling to Improve Lower Extremity Strength): A Prospective Pilot Study of the Safety and Feasibility of Early In-bed Leg Cycle Ergometry 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. The
investigators 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 safety (Is it safe?) and feasibility (Can the
investigators do it?) are needed.
Objectives: To study the safety and feasibility of in-bed leg cycling 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. Specially trained physiotherapists will provide
patients with 30 minutes of in-bed cycling each day while they are in the ICU.
Outcomes: The investigators will study (1) Safety: the heart rate and breathing patterns of
patients doing in-bed cycling, while carefully monitoring for safety. (2) 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 the investigators 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 first 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.
n/a
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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