End Stage Liver Disease, Liver Cirrhoses, Sarcopenia
Conditions
Keywords
Liver Transplantation
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.
Interventions
BEHAVIORALExercise 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.
Sponsors
Johns Hopkins University
Duke University
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Liver Frailty Index | 12 and 24 weeks after enrollment | Liver Frailty Index as measured by score in functional assessments of grip strength (kg), balance (seconds), and chair stands (seconds). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality at 24 weeks | 1 year | Mortality status at 24 weeks |
| Hospitalized days at 24 weeks | 1 year | Number of days in the hospital from baseline to 24 weeks |
| Quality of Life by CLDQ | 12 and 24 weeks after enrollment | Quality of life assessed by the CLDQ at 12 and 24 weeks after enrollment |
Countries
United States
Outcome results
None listed