TryCYCLE: A Pilot Study of Early In-bed Leg Cycle Ergometry in Mechanically Ventilated Patients
Sponsored by McMaster University
About this trial
Last updated 9 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended 10 years ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
- Adult patients ≥18 years old
- Invasively mechanically ventilated ≤4 days
- Expected additional 2 day ICU stay
- Ability to ambulate independently pre-hospital (with or without a gait aid)
Exclusion Criteria
- Unable to follow simple commands at baseline
- Pregnancy
- Acute conditions impairing ability to walk or cycle (e.g., leg or foot fracture)
- Acute central condition or peripheral injury resulting in neuromuscular weakness (e.g., stroke, Guillain Barré syndrome)
- Primary generalized weakness of the central or peripheral nervous system (e.g., multiple sclerosis, myasthenia gravis, Parkinson's disease, amyotrophic lateral sclerosis)
- Temporary pacemaker wires
- Expected hospital mortality> 90%
- Cycling equipment unable to fit patient's body dimensions (e.g., leg amputation or obesity)
- Specific surgical exclusion as stipulated by attending ->7 day ICU stay
- Physician declines
- Patient did not meet daily screening criteria to provide in-bed leg cycling during the first 4 days of mechanical ventilation