An interventional study of Cycle ergometry in Liver Cirrhoses, Liver Failure and ICU Acquired Weakness, sponsored by Medical College of Wisconsin. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-20.
Sponsored by Medical College of Wisconsin · Not applicable, Interventional, and Treatment
Critically-ill patients with liver disease are at high risk of developing sarcopenia and intensive care unit (ICU)-acquired weakness, which are associated with mortality and other poor outcomes. Early physical rehabilitation has shown benefit in ICU settings, but has not been studied in ICU patients with acute and chronic liver failure. Cycle ergometry, or stationary cycling in passive and active modes, may be especially beneficial to such patients due to their high prevalence of severe physical deconditioning and variable mentation. The aim of this study is to examine the feasibility, safety, and benefit of cycle ergometry over standard physical and occupational therapy (PT/OT) in critically-ill patients who have acute or chronic liver disease.
A single-blinded randomized controlled trial will be conducted in a transplant intensive care unit (TICU). Eligible adult patients will be enrolled within 72 hrs after TICU admission and randomly allocated to either (1) standard PT/OT care, or (2) PT/OT care and cycle ergometry sessions with trained PT/OT therapists or technicians. The outcome measures, tests of strength and function, will be assessed at baseline, every 14 days, and upon TICU discharge by a blinded PT/OT therapist.
1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.
This study's enrollment of 97 is above the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →Medical College of Wisconsin is the lead sponsor of 540 studies on the registry; 120 are open to participants now.
Of its 71 completed or terminated interventional studies of FDA-regulated products, 56 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The study intervention will include the same standard PT/OT procedures as the control arm (Standard PT/OT alone) with the addition of the Motomed Letto 2 lower extremity cycle ergometry sessions.
Device: Cycle ergometry
The control arm will involve standard PT/OT procedures that patients in the transplant intensive care unit receive routinely, with frequency to be determined by a physical and/or occupational therapist, and may include but are not limited to the following: Passive and active upper and lower extremity strength exercises, while in bed, sitting upright, and standing; stretching various muscle groups while supine in bed, sitting upright, and standing; in-bed mobility training including rolling and boosting; transfer training with and without an assistive device; gait training with and without an assistive device; balance exercises while sitting and standing; activities of daily living while sitting and standing; cognitive retraining
Lower extremity cycle ergometry, passive and/or active, up to 20 minutes per session, up to 5 sessions per week
Functional Status Score for the Intensive Care Unit (FSS-ICU)
Standardized assessment tool for functional status in ICU patients. Score ranges from 0 (unable to perform) to 35 (highest function).
Time frame: Through study completion, average of 1 year
Number of participants who experience an adverse event during therapy
Total number of participants who experience an adverse event during PT/OT and cycling sessions during course of study
Time frame: Through study completion, average of 1 year
Duration of mechanical ventilation
Average number of days on mechanical ventilation
Time frame: Through study completion, average of 1 year
ICU length of stay
Average length of stay in days
Time frame: Through study completion, average of 1 year
Number of participants who experience ICU readmission
Total number of participants readmitted to ICU during study period
Time frame: Through study completion, average of 1 year
This study is terminated, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Medical College of Wisconsin