Exercise Intervention in Liver Transplant Patients

The purpose of this study is to learn more about the effects of exercise on functional status and outcomes on patients with end-stage liver disease on the liver transplant waiting list and who have undergone liver transplantation.

Study Overview

• Status: Completed
• Conditions: End Stage Liver Disease; Sarcopenia; Liver Cirrhoses
• Intervention / Treatment: Behavioral: Exercise Program

Detailed Description

This study aims to evaluate the effects of a home-based exercise intervention on outcomes in liver transplant candidates and recipients. This home-based intervention consists of a 30-minute exercise session available on digital video disc or on the internet. This intervention was originally developed to improve functional status in community-dwelling older adults and therefore, has been designed to maximize the safety for even the most frail individuals. Subjects enrolled in this study will be randomized to one of two arms: (a) the exercise intervention arm in which the subjects will be asked perform this exercise session three to four times per week or (b) the standard-of-care arm in which the patient will be encouraged to exercise by their transplant clinician at every clinic visit. Subjects in the exercise intervention arm will undergo this intervention for 6 months. All subjects will be followed for up to two years from the time of enrollment to ascertain outcomes.

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • Johns Hopkins University
  • North Carolina
    • Durham, North Carolina, United States, 27708
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult (>=18 years of age)
• Listed for liver transplantation or post-liver transplantation
• English speaking

Exclusion Criteria:

• Contraindications to weight-bearing exercise
• Non-English speaking
• Requires an assistive device for ambulation
• Active hepatic encephalopathy at the time of baseline assessment for enrollment in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise Program; The exercise intervention consists of a 30 minute exercise session led by an instructor through a DVD or a video available on the internet.	Behavioral: Exercise Program; They will perform low-intensity, low-resistance exercise facilitated by a DVD video in their home. This exercise program lasts for 30 minutes at a time. Patients will be instructed to engage in this exercise program 3-4 times per week but not more often than 4 times per week. Pre-transplant patients will be asked to do the exercises from enrollment to transplant. Post-transplant patients will be asked to do the exercises for 6 months.
No Intervention: Standard of care; Standard of care which consists of encouragement to exercise by the subject's transplant clinician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver Frailty Index	Liver Frailty Index as measured by score in functional assessments of grip strength (kg), balance (seconds), and chair stands (seconds).	12 and 24 weeks after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality at 24 weeks	Mortality status at 24 weeks	1 year
Hospitalized days at 24 weeks	Number of days in the hospital from baseline to 24 weeks	1 year
Quality of Life by CLDQ	Quality of life assessed by the CLDQ at 12 and 24 weeks after enrollment	12 and 24 weeks after enrollment

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Johns Hopkins University; Duke University

Publications and helpful links

General Publications

• Dasarathy S. Consilience in sarcopenia of cirrhosis. J Cachexia Sarcopenia Muscle. 2012 Dec;3(4):225-37. doi: 10.1007/s13539-012-0069-3. Epub 2012 May 31.
• Jones JC, Coombes JS, Macdonald GA. Exercise capacity and muscle strength in patients with cirrhosis. Liver Transpl. 2012 Feb;18(2):146-51. doi: 10.1002/lt.22472.
• Murray KF, Carithers RL Jr; AASLD. AASLD practice guidelines: Evaluation of the patient for liver transplantation. Hepatology. 2005 Jun;41(6):1407-32. doi: 10.1002/hep.20704. No abstract available.
• Lai JC, Feng S, Terrault NA, Lizaola B, Hayssen H, Covinsky K. Frailty predicts waitlist mortality in liver transplant candidates. Am J Transplant. 2014 Aug;14(8):1870-9. doi: 10.1111/ajt.12762. Epub 2014 Jun 16.

Helpful Links

• National Center for Health Statistics
• United Network for Organ Sharing

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: December 20, 2014
• First Submitted That Met QC Criteria: February 12, 2015
• First Posted (Estimate): February 20, 2015

Study Record Updates

• Last Update Posted (Actual): September 7, 2022
• Last Update Submitted That Met QC Criteria: September 2, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Liver Transplantation
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Fibrosis; Muscular Atrophy; Atrophy; Liver Diseases; End Stage Liver Disease; Liver Cirrhosis; Sarcopenia
• Other Study ID Numbers: 14-14783