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

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.

Study Overview

• Status: Terminated
• Conditions: Liver Failure; ICU Acquired Weakness; Liver Cirrhoses
• Intervention / Treatment: Device: Cycle ergometry

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 Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Investigators: Principal Investigator: Priyal Patel, MD, Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2019
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: November 6, 2019
• First Submitted That Met QC Criteria: November 8, 2019
• First Posted (Actual): November 12, 2019

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Rehabilitation; Physical Therapy; Cycle Ergometry
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Failure; Hepatic Insufficiency; Liver Cirrhosis
• Other Study ID Numbers: PRO32773

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes