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Exercise Intervention in Liver Transplant Patients

Primary Purpose

End Stage Liver Disease, Sarcopenia, Liver Cirrhoses

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Program
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Liver Disease focused on measuring Liver Transplantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, San Francisco
  • Johns Hopkins University
  • Duke University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise Program

Standard of care

Arm Description

The exercise intervention consists of a 30 minute exercise session led by an instructor through a DVD or a video available on the internet.

Standard of care which consists of encouragement to exercise by the subject's transplant clinician.

Outcomes

Primary Outcome Measures

Liver Frailty Index
Liver Frailty Index as measured by score in functional assessments of grip strength (kg), balance (seconds), and chair stands (seconds).

Secondary Outcome Measures

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

Full Information

First Posted
December 20, 2014
Last Updated
September 2, 2022
Sponsor
University of California, San Francisco
Collaborators
Johns Hopkins University, Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT02367092
Brief Title
Exercise Intervention in Liver Transplant Patients
Official Title
Exercise Intervention in Liver Transplant Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Johns Hopkins University, Duke University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Liver Disease, Sarcopenia, Liver Cirrhoses
Keywords
Liver Transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise Program
Arm Type
Experimental
Arm Description
The exercise intervention consists of a 30 minute exercise session led by an instructor through a DVD or a video available on the internet.
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Standard of care which consists of encouragement to exercise by the subject's transplant clinician.
Intervention Type
Behavioral
Intervention Name(s)
Exercise Program
Intervention Description
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 Outcome Measure Information:
Title
Liver Frailty Index
Description
Liver Frailty Index as measured by score in functional assessments of grip strength (kg), balance (seconds), and chair stands (seconds).
Time Frame
12 and 24 weeks after enrollment
Secondary Outcome Measure Information:
Title
Mortality at 24 weeks
Description
Mortality status at 24 weeks
Time Frame
1 year
Title
Hospitalized days at 24 weeks
Description
Number of days in the hospital from baseline to 24 weeks
Time Frame
1 year
Title
Quality of Life by CLDQ
Description
Quality of life assessed by the CLDQ at 12 and 24 weeks after enrollment
Time Frame
12 and 24 weeks after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer C Lai, MD, MBA
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27708
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15880505
Citation
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.
Results Reference
background
PubMed Identifier
24935609
Citation
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.
Results Reference
background
PubMed Identifier
22648736
Citation
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.
Results Reference
background
PubMed Identifier
22139897
Citation
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.
Results Reference
background
Links:
URL
http://www.cdc.gov/nchs/faststats/liver-disease.htm
Description
National Center for Health Statistics
URL
https://optn.transplant.hrsa.gov
Description
United Network for Organ Sharing

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Exercise Intervention in Liver Transplant Patients

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