ICU Acquired Weakness, Liver Cirrhoses, Liver Failure
Conditions
Keywords
Cycle Ergometry, Physical Therapy, Rehabilitation
Brief summary
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
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.
Interventions
DEVICECycle ergometry
Lower extremity cycle ergometry, passive and/or active, up to 20 minutes per session, up to 5 sessions per week
Sponsors
Medical College of Wisconsin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Status Score for the Intensive Care Unit (FSS-ICU) | Through study completion, average of 1 year | Standardized assessment tool for functional status in ICU patients. Score ranges from 0 (unable to perform) to 35 (highest function). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who experience an adverse event during therapy | Through study completion, average of 1 year | Total number of participants who experience an adverse event during PT/OT and cycling sessions during course of study |
| Duration of mechanical ventilation | Through study completion, average of 1 year | Average number of days on mechanical ventilation |
| ICU length of stay | Through study completion, average of 1 year | Average length of stay in days |
| Number of participants who experience ICU readmission | Through study completion, average of 1 year | Total number of participants readmitted to ICU during study period |
Countries
United States
Outcome results
None listed