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

• Sponsor: Melissa Wong, MD, FACS (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04160039
• Collaborator: (none)
• Enrollment: 201
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 61.7
• Patients Per Site Per Month: 3.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Cirrhoses; Liver Failure; ICU Acquired Weakness	Device: Cycle ergometry	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 201 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Early Cycle Ergometry for Critically-Ill Liver Failure Patients in a Transplant Intensive Care Unit
• Actual Study Start Date: Nov 10, 2019
• Anticipated Primary Completion Date: Jan 31, 2022
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cycle Ergometry + Standard PT/OT	Device: Cycle ergometry; Lower extremity cycle ergometry, passive and/or active, up to 20 minutes per session, up to 5 sessions per week
No Intervention: Standard PT/OT alone

Outcome Measures

Primary Outcome Measures

1. Functional Status Score for the Intensive Care Unit (FSS-ICU) [Through study completion, average of 1 year]

   Standardized assessment tool for functional status in ICU patients. Score ranges from 0 (unable to perform) to 35 (highest function).

Secondary Outcome Measures

1. Number of participants who experience an adverse event during therapy [Through study completion, average of 1 year]

2. Duration of mechanical ventilation [Through study completion, average of 1 year]

3. ICU length of stay [Through study completion, average of 1 year]

4. Number of participants who experience ICU readmission [Through study completion, average of 1 year]

5. Post-transplant survival [Up to five years]

Other Outcome Measures

1. Medical Research Council Sum Score (MRC) [Through study completion, average of 1 year]

   Range from 0 (paralysis) to 60 (normal strength)

2. 5-times Sit-to-Stand time [Through study completion, average of 1 year]

3. Dynamometry [Through study completion, average of 1 year]

   Handgrip strength will be measured with a dynamometer

4. Activity Measure for Post-Acute Care (AM-PAC) 6-Clicks [Through study completion, average of 1 year]

   Ranges from 6 (complete functional impairment) to 24 (full function)

5. Johns Hopkins Highest Level of Mobility (JH-HLM) [Through study completion, average of 1 year]

   Ranges from 1 (lying in bed) to 8 (walks 250 feet or more)

6. Number of participants who do not have decisional capacity [Through study completion, average of 1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226

Sponsors and Collaborators

• Melissa Wong, MD, FACS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Melissa Wong, MD, FACS, Assistant Professor of Surgery, Medical College of Wisconsin
• ClinicalTrials.gov Identifier: NCT04160039
• Other Study ID Numbers: PRO32773
• First Posted: Nov 12, 2019
• Last Update Posted: May 10, 2021
• Last Verified: May 1, 2021

• 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
• Keywords provided by Melissa Wong, MD, FACS, Assistant Professor of Surgery, Medical College of Wisconsin: Cycle Ergometry; Physical Therapy; Rehabilitation
• Additional relevant MeSH terms: Liver Cirrhosis; Liver Failure; Hepatic Insufficiency

Study Results

No Results Posted as of May 10, 2021