Exercise Intervention in Liver Transplant Patients

NCT ID: NCT02367092

Last Updated: 2022-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2019-12-31

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.

Conditions

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End Stage Liver Disease Sarcopenia Liver Cirrhoses

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Exercise Program

Intervention Type 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.

Standard of care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer C Lai, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status

Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Duke University

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 15880505 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24935609 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22648736 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22139897 (View on PubMed)

Related Links

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https://optn.transplant.hrsa.gov

United Network for Organ Sharing

Other Identifiers

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14-14783

Identifier Type: -

Identifier Source: org_study_id

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