Exercise Intervention in Liver Transplant Patients

Sarcopenia Clinical Trial

Official title:

Exercise Intervention in Liver Transplant Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02367092
• Other study ID #: 14-14783
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: December 2019

Study information

• Verified date: September 2022
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Liver Disease
• Liver Cirrhoses
• Liver Cirrhosis
• Liver Diseases
• Sarcopenia

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Duke University	Durham	North Carolina
United States	University of California, San Francisco	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	Duke University, Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. Review. — View 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. — View Citation

Murray KF, Carithers RL Jr; AASLD. AASLD practice guidelines: Evaluation of the patient for liver transplantation. Hepatology. 2005 Jun;41(6):1407-32. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mortality at 24 weeks	Mortality status at 24 weeks	1 year
Secondary	Hospitalized days at 24 weeks	Number of days in the hospital from baseline to 24 weeks	1 year
Secondary	Quality of Life by CLDQ	Quality of life assessed by the CLDQ at 12 and 24 weeks after enrollment	12 and 24 weeks after enrollment

External Links

•   National Center for Health Statistics