Exercise Intervention in Liver Transplant Patients

Not Applicable

Completed

• Conditions: Sarcopenia; End Stage Liver Disease; Liver Cirrhoses
• Interventions: Behavioral: Exercise Program

• Registration Number: NCT02367092
• Lead Sponsor: University of California, San Francisco

Brief Summary

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

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 Timeline

• Study First Submitted: 2014-12-20
• Study First Submitted QC: 2015-02-12
• Study First Posted: 2015-02-20
• Study Start: 2016-07
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-02
• Last Update Posted: 2022-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise Program	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States