Early Cycle Ergometry for Critically-Ill Liver Failure Patients in a Transplant Intensive Care Unit

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Early Cycle Ergometry for Critically-Ill Liver Failure Patients in a Transplant Intensive Care Unit

Conditions
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Liver Cirrhoses, Liver Failure, ICU Acquired Weakness

Intervention / Treatment
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* Device: Cycle ergometry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults 18 ≥ years with acute or chronic liver disease admitted to Transplant Intensive Care Unit (TICU), or admitted to TICU following a liver or liver-kidney transplant Expected to remain in ICU for ≥ 5 days Spoken English fluency Exclusion Criteria: Known primary systemic neuromuscular disease or intracranial process causing increased intracranial pressure Lower extremity amputation Anticipated death or palliative withdrawal of life support within 5 days Cycle ergometer weight limit (135 kg or 297.6 lbs per manufacturer)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cycle Ergometry + Standard PT/OT<br>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<br>* Lower extremity cycle ergometry, passive and/or active, up to 20 minutes per session, up to 5 sessions per week<br>|
| No Intervention: Standard PT/OT alone<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Through study completion, average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Through study completion, average of 1 year | 
| Duration of mechanical ventilation | Average number of days on mechanical ventilation | Through study completion, average of 1 year | 
| ICU length of stay | Average length of stay in days | Through study completion, average of 1 year | 
| Number of participants who experience ICU readmission | Total number of participants readmitted to ICU during study period | Through study completion, average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cycle Ergometry, Physical Therapy, Rehabilitation