Exercise Intervention in Liver Transplant Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Exercise Intervention in Liver Transplant Patients

Conditions
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End Stage Liver Disease, Sarcopenia, Liver Cirrhoses

Intervention / Treatment
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* Behavioral: Exercise Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Program<br>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<br>* 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.<br>|
| No Intervention: Standard of care<br>Standard of care which consists of encouragement to exercise by the subject's transplant clinician. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver Transplantation