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Completed

NCT Number: NCT02367092

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.

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Key information

Conditions

End Stage Liver Disease Atrophy Digestive System Diseases Hepatic Insufficiency Liver Cirrhoses Liver Diseases Liver Failure Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco, San Francisco, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise Program

Behavioral

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.

Primary outcomes

  1. Liver Frailty Index

    Time frame: 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 outcomes

  1. Mortality at 24 weeks

    Time frame: 1 year

    Mortality status at 24 weeks

  2. Hospitalized days at 24 weeks

    Time frame: 1 year

    Number of days in the hospital from baseline to 24 weeks

  3. Quality of Life by CLDQ

    Time frame: 12 and 24 weeks after enrollment

    Quality of life assessed by the CLDQ at 12 and 24 weeks after enrollment

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Duke University
  • Johns Hopkins University

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 20, 2015
Registry last updated
Sep 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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