Status:
COMPLETED
TryCYCLE: A Pilot Study of Early In-bed Leg Cycle Ergometry in Mechanically Ventilated Patients
Lead Sponsor:
McMaster University
Collaborating Sponsors:
St. Joseph's Healthcare Hamilton
Conditions:
Intensive Care Unit Acquired Weakness
Critical Care
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01885442
Start Date
September 1 2013
End Date
January 1 2015
Last Update
April 6 2016
Active Locations (1)
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1
St. Joseph's Healthcare Intensive Care Unit
Hamilton, Ontario, Canada, L8N 4A6