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

NCT04160039 | Terminated

• 1 other identifier: PRO32773
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhoses; Liver Failure; ICU Acquired Weakness

Keywords

Cycle Ergometry; Physical Therapy; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of participants who experience an adverse event during therapy

  Through study completion, average of 1 year

• Duration of mechanical ventilation

  Through study completion, average of 1 year

• ICU length of stay

  Through study completion, average of 1 year

• Number of participants who experience ICU readmission

  Through study completion, average of 1 year

Study Arms (2)

Cycle Ergometry + Standard PT/OT

EXPERIMENTAL

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

Standard PT/OT alone

NO INTERVENTION

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

Interventions

Cycle ergometry DEVICE

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

Cycle Ergometry + Standard PT/OT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Liver Failure

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Officials

• Priyal Patel, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 12, 2019
• Study Start: November 10, 2019
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: March 20, 2024

Record last verified: 2024-03

Locations

US (1)