Exercise Intervention in Liver Transplant Patients

NCT02367092 | Completed DMC

• 1 other identifier: 14-14783
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 3

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.

Conditions

End Stage Liver Disease; Sarcopenia; Liver Cirrhoses

Keywords

Liver Transplantation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Mortality at 24 weeks

  1 year

• Hospitalized days at 24 weeks

  1 year

• Quality of Life by CLDQ

  12 and 24 weeks after enrollment

Study Arms (2)

Exercise Program

EXPERIMENTAL

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

Standard of care

NO INTERVENTION

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

Interventions

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.

Exercise Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (\>=18 years of age)
• Listed for liver transplantation or post-liver transplantation
• English speaking

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Johns Hopkins University: collaborator
• Duke University: collaborator

Study Sites (3)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21218, United States

Location

Duke University

Durham, North Carolina, 27708, United States

Location

Related Publications (4)

• 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.

  PMID: 15880505 BACKGROUND

• 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.

  PMID: 24935609 BACKGROUND

• 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.

  PMID: 22648736 BACKGROUND

• 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.

  PMID: 22139897 BACKGROUND

Related Links

• United Network for Organ Sharing

MeSH Terms

Conditions

End Stage Liver Disease; Sarcopenia

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jennifer C Lai, MD, MBA

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2014
• First Posted: February 20, 2015
• Study Start: July 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: September 7, 2022

Record last verified: 2022-09

Locations

US (3)