Frailty is common in patients with end-stage liver disease. It's characterized by reduced strength, low endurance and reduced physical function. While exercise intervention can improve frailty in geriatric patients without liver disease, whether or not exercise intervention can improve frailty in liver transplant candidates remains unknown.
The long-term goal is to better understand how exercise impacts frailty in order to identify treatments that can improve both patient-oriented outcomes and access to liver transplantation for end-stage liver disease patients. The specific objective of this proposal is to generate pilot feasibility data required for future multicenter R01 application to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) which will test the novel central hypothesis that exercise improves frailty and lessens waiting-list mortality. Additionally, another goal of the study is to establish an optimal frailty tool for liver transplant candidates.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Subjects in this group will be asked to exercise 5 days a week. Two days on-site with an Exercise Physiologist and the other 3 days at home.
Number of participants able to complete the trial
Defined as 50% of subjects completing \>80% of the sessions.
Time frame: up to 52 weeks
Incidence of Treatment-Emergent Adverse Events as assessed by GCP guidelines
This study aims to examine the incidence of adverse events. If exercise in frail liver transplant candidates is safe. 5% serious adverse events or fewer will deem the trial as safe. If more than 5% serious adverse events occur, the trial is determined to be unsafe.
Time frame: up to 52 weeks
Rate of enrollment
Net enrollment rates, which are calculated by dividing the number of subjects approached by the number of subjects that enroll in the trial. The work with the ongoing NASHFit and completed ENACT Trials and the work of others performing exercise-based trials in patients with cirrhosis(50) has established \>50% enrollment of subjects approached as a threshold of acceptability.
Time frame: up to 52 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.