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

NCT ID: NCT04160039

Last Updated: 2024-03-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-10
• Study Completion Date: 2022-09-01

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.

Conditions

Liver Cirrhoses; Liver Failure; ICU Acquired Weakness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cycle ergometry

Intervention Type: DEVICE

Lower extremity cycle ergometry, passive and/or active, up to 20 minutes per session, up to 5 sessions per week

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cycle ergometry

Lower extremity cycle ergometry, passive and/or active, up to 20 minutes per session, up to 5 sessions per week

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Priyal Patel, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

PRO32773

Identifier Type: -

Identifier Source: org_study_id