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

Not Applicable

Terminated

• Conditions: Liver Cirrhoses; ICU Acquired Weakness; Liver Failure
• Interventions: Device: Cycle ergometry

• Registration Number: NCT04160039
• Lead Sponsor: Medical College of Wisconsin

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.

Study Timeline

• Study First Submitted: 2019-11-06
• Study First Submitted QC: 2019-11-08
• Study Start: 2019-11-10
• Study First Posted: 2019-11-12
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-18
• Last Update Posted: 2024-03-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 97

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cycle Ergometry + Standard PT/OT	Cycle ergometry	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of participants who experience ICU readmission	Through study completion, average of 1 year	Total number of participants readmitted to ICU during study period
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
ICU length of stay	Through study completion, average of 1 year	Average length of stay in days
Duration of mechanical ventilation	Through study completion, average of 1 year	Average number of days on mechanical ventilation

Trial Locations

Locations (1)

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States