Clinical trial NCT02367092: Exercise Intervention in Liver Transplant Patients
Official title: Exercise Intervention in Liver Transplant Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Liver Disease
Sarcopenia
Liver Cirrhoses
Keywords: Liver Transplantation
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: Duke University
First posted: 2015-02-20
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Liver Frailty Index
timeFrame: 12 and 24 weeks after enrollment
Secondary outcomes:
measure: Mortality at 24 weeks
timeFrame: 1 year
measure: Hospitalized days at 24 weeks
timeFrame: 1 year
measure: Quality of Life by CLDQ
timeFrame: 12 and 24 weeks after enrollment
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: University of California, San Francisco
name: Jennifer C Lai, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.