NCT04160039

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Cirrhoses
• Liver Failure
• ICU Acquired Weakness

Interventions

Type	Name	Description
DEVICE	Cycle ergometry	Lower extremity cycle ergometry, passive and/or active, up to 20 minutes per session, up to 5 sessions per week

Timeline

• Start date: 2019-11-10
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2019-11-12
• Last updated: 2024-03-20

Locations

1 site across 1 country: United States