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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04160039
Other study ID # PRO32773
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date November 10, 2019
Est. completion date September 1, 2022

Study information

Verified date March 2024
Source Medical College of Wisconsin
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 97
Est. completion date September 1, 2022
Est. primary completion date September 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

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

Locations

Country Name City State
United States Medical College of Wisconsin Milwaukee Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary Duration of mechanical ventilation Average number of days on mechanical ventilation Through study completion, average of 1 year
Secondary ICU length of stay Average length of stay in days Through study completion, average of 1 year
Secondary Number of participants who experience ICU readmission Total number of participants readmitted to ICU during study period Through study completion, average of 1 year
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