Frailty, Liver Transplants
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALExercise intervention
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.
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
An interventional pilot trial will be performed with 21 randomized subjects who are aged 18-75 years who are frail according to the LFI to a 3-month exercise intervention (n=14) versus standard of care (n=7) with no change in activity.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adults age ≥18 or ≤75 years * Frail as defined by a LFI score of \>4.5 * Under evaluation or listed for liver transplant
Exclusion criteria
* Active cardiac symptoms (e.g., chest pain, shortness of breath at rest, palpitations) * Positive response to Get Active Questionnaire (GAQ) (validated activity questionnaire that indicates if exercise is unsafe) * Institutionalized/prisoner * Severe medical comorbidities/psychiatric illness at the discretion of the Study Principal Investigator (PI)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants able to complete the trial | up to 52 weeks | Defined as 50% of subjects completing \>80% of the sessions. |
| Incidence of Treatment-Emergent Adverse Events as assessed by GCP guidelines | up to 52 weeks | 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. |
| Rate of enrollment | up to 52 weeks | 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. |
Outcome results
None listed