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

NCT04160039 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2024-03-20

No results posted yet for this study

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

Interventions

DEVICE

Cycle ergometry

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

Sponsors & Collaborators

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Priyal Patel, MD · Medical College of Wisconsin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-10
Primary Completion
2022-09-01
Completion
2022-09-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04160039 on ClinicalTrials.gov