Back to resultsEarly Cycle Ergometry for Critically-Ill Liver Failure Patients in a Transplant Intensive Care Unit
Primary Purpose
Liver Cirrhoses, Liver Failure, ICU Acquired Weakness
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cycle ergometry
Sponsored by
About this trial
This is an interventional treatment trial for Liver Cirrhoses focused on measuring Cycle Ergometry, Physical Therapy, Rehabilitation
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)
Sites / Locations
- Medical College of Wisconsin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Cycle Ergometry + Standard PT/OT
Standard PT/OT alone
Arm Description
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.
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
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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
Duration of mechanical ventilation
Average number of days on mechanical ventilation
ICU length of stay
Average length of stay in days
Number of participants who experience ICU readmission
Total number of participants readmitted to ICU during study period
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04160039
Brief Title
Early Cycle Ergometry for Critically-Ill Liver Failure Patients in a Transplant Intensive Care Unit
Official Title
Early Cycle Ergometry for Critically-Ill Liver Failure Patients in a Transplant Intensive Care Unit
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
Principal Investigator left institution
Study Start Date
November 10, 2019 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
September 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Priyal Patel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhoses, Liver Failure, ICU Acquired Weakness
Keywords
Cycle Ergometry, Physical Therapy, Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cycle Ergometry + Standard PT/OT
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard PT/OT alone
Arm Type
No Intervention
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Cycle ergometry
Intervention Description
Lower extremity cycle ergometry, passive and/or active, up to 20 minutes per session, up to 5 sessions per week
Primary Outcome Measure Information:
Title
Functional Status Score for the Intensive Care Unit (FSS-ICU)
Description
Standardized assessment tool for functional status in ICU patients. Score ranges from 0 (unable to perform) to 35 (highest function).
Time Frame
Through study completion, average of 1 year
Secondary Outcome Measure Information:
Title
Number of participants who experience an adverse event during therapy
Description
Total number of participants who experience an adverse event during PT/OT and cycling sessions during course of study
Time Frame
Through study completion, average of 1 year
Title
Duration of mechanical ventilation
Description
Average number of days on mechanical ventilation
Time Frame
Through study completion, average of 1 year
Title
ICU length of stay
Description
Average length of stay in days
Time Frame
Through study completion, average of 1 year
Title
Number of participants who experience ICU readmission
Description
Total number of participants readmitted to ICU during study period
Time Frame
Through study completion, average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Priyal Patel, MD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Early Cycle Ergometry for Critically-Ill Liver Failure Patients in a Transplant Intensive Care Unit
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