Cirrhosis, Frailty, Liver Transplant
Conditions
Brief summary
Frailty is a significant problem in patients undergoing liver transplant and is associated with poor outcomes and survival. Hence, optimizing physical fitness and counteracting frailty is important. However, many interventions are very resource intensive and therefore not feasible. In this study, the investigators aim to test the effectiveness of a newly designed intervention to improve frailty in liver transplant candidates. The "LIver FrailTy" intervention (LIFT) will consist of an evaluation by a physical therapist, an individualized home exercise prescription (HEP), exercise tracking using a smart phone application, daily text reminders to exercise and recurrent telephone check-ins.
Detailed description
Frailty is defined as a biologic syndrome of decreased physiologic reserve and increased vulnerability to health stressors. The concept of frailty has recently emerged as a critical determinant in the field of cirrhosis and liver transplantation. Frailty impacts pre- and post-transplant clinical outcomes, including waitlist mortality, post-transplant mortality, frequency of hospitalizations and duration of hospital admissions. Although the impact of frailty in liver transplantation has been established in the literature, there is a lack of data supporting effective interventions to decrease frailty prior to liver transplantation. Moreover, the studies that have tested interventions to improve physical function have relied on frequent supervised physical therapy (PT) sessions and access to exercise equipment that it is not financially or logistically feasible for the majority of patients. Patient engagement in PT also remains a critical barrier to overcome to decrease frailty in preparation for liver transplantation. Developing a practical and effective intervention to consistently engage patients in physical activity and decrease frailty is essential to improving clinical outcomes in the pre- and post-liver transplant setting. The investigators goal is to pilot test a novel PT intervention to decrease frailty in pre-transplant patients. The investigators have designed a prototype "LIver FrailTy" intervention (LIFT) that includes: PT evaluation, an individualized home exercise prescription (HEP), daily text message reminders to exercise and weekly telephone check-ins with team members. The central hypothesis is that the LIFT intervention will 1) improve adherence to recommended levels of exercise in end-stage liver disease 2) reduce pre-transplant frailty and 3) will improve pre- and post-transplant clinical outcomes.
Interventions
BEHAVIORAL"LIver FrailTy" intervention (LIFT)
Novel physical therapy intervention to decrease frailty in pre-transplant patients
Sponsors
Northwestern University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with a diagnosis of liver cirrhosis being evaluated for liver transplantation in hepatology/transplant evaluation clinic * English-speaking * Patients with access to a smart phone (with videoconference capabilities) * Vulnerable populations: We will include patients who are cognitively impaired due to hepatic encephalopathy and unable to consent for themselves.
Exclusion criteria
* Patients \< 18 years of age * Patients who require outpatient physical therapy. * Patients without the ability to consent for themselves or through a medical power of attorney.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frailty | Baseline and final frailty assessment (mean time from baseline to final frailty assessment was 216 (± 157) days) | Frailty is described as a biologic syndrome of decreased physiologic reserve and increased vulnerability to health stressors. This outcome is measured by the Liver frailty index \[LFI\]. LFI is composed of 3 performance-based tests (grip strength, chair stands, and balance). Patients are classified using established cutoffs (frail: LFI ≥ 4.5, pre-frail: LFI 3.3-4.4, robust: LFI ≤ 3.2). Higher LFI scores indicate a higher degree of frailty. |
| Patient-reported Physical Function | Baseline and final frailty assessment (mean time from baseline to final frailty assessment was 216 (± 157) days) | Patient-reported physical quality of life was measured using a validated patient-reported outcome measure (Patient-Reported Outcomes Measurement Information System Physical Function \[PROMIS-PF\]) completed in clinic. Patient-reported physical function was measured using a validated patient-reported outcome measure: Patient-Reported Outcomes Measurement Information System Physical Function \[PROMIS-PF\] Version 2.0 - Short Form 8c. A higher PROMIS T-score represents more of the concept being measured. A score of 50 is the average for the United States general population with a standard deviation of 10. A Physical Function T-score of 60 is one SD better than average. By comparison, a Physical Function T-score of 40 is one SD worse than average. Physical Function T-Scores range from 20.3 to 60.1. |
| Exercise Adherence Rate | 1 month and 3 months after Enrollment, throughout the follow-up period (mean follow-up time is 259 (±190) days) | Data continuously collected via TrueCoach smart phone application to document adherence to exercise regimen. If patients are unable to appropriately track adherence on the smart phone application, this data will be collected at weekly videoconference/telephone check-ins detailed below. Exercise adherence rates are defined as the number of completed or attempted exercise days/total exercise days prescribed. Overall, patients were classified as adherent to the exercise regimen if their adherence rate was ≥ 75% and partially adherent if ≥ 50%. Patients were classified as non-adherent if their adherence rate was \< 50%. The mean intervention rate was measured throughout the follow-up period (from enrollment to final assessment) - the mean follow-up time was 259 (±190) days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Outcomes - Liver Related Complications | Throughout the follow-up period (mean follow-up time is 259 (±190) days) | Data collected from medical chart for liver related complications including but not limited to diagnosis of: ascites, hepatic encephalopathy, variceal bleeding, hepatorenal syndrome, hepatopulmonary syndrome, infection. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDaniela Ladner, MD
Northwestern University
Participant flow
Pre-assignment details
The study team proposed to employ a "Realistic Effort Action Planning" (REAP) intervention, which is a form of personality-informed motivational interviewing, in a subset of patients to determine if this enhances the LIFT intervention. Due to funding and time restrictions, the study team was unable to employ this intervention and focused solely on the LIFT intervention. The record has been revised appropriately and these details have also been provided in the Limitations section.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 57.2 years STANDARD_DEVIATION 9.9 |
| Baseline Frailty Status by Liver Frailty Index Frail (LFI ≥ 4.5) | 17 Participants |
| Baseline Frailty Status by Liver Frailty Index Pre-Frail (LFI 3.3-4.4) | 23 Participants |
| Baseline Frailty Status by Liver Frailty Index Robust (LFI ≤ 3.2) | 14 Participants |
| Baseline Liver Frailty Index | 3.63 units on a scale STANDARD_DEVIATION 0.6 |
| Baseline Patient-Reported Physical Function T-score | 46.6 units on a scale STANDARD_DEVIATION 8.3 |
| Beta-blocker prescribed | 11 Participants |
| BMI | 29.2 kg/m² STANDARD_DEVIATION 5.9 |
| Comorbidities Chronic Kidney Disease | 3 Participants |
| Comorbidities Coronary Artery Disease | 2 Participants |
| Comorbidities Diabetes Mellitus II | 11 Participants |
| Comorbidities Hyperlipidemia | 8 Participants |
| Comorbidities Hypertension | 10 Participants |
| Decompensated Ascites | 31 Participants |
| Decompensated Hepatic encephalopathy | 22 Participants |
| Decompensated Hepatocellular Carcinoma | 11 Participants |
| Decompensated History of Spontaneous Bacterial Peritonitis | 2 Participants |
| Decompensated History of Variceal Bleeding | 27 Participants |
| Etiology of Liver Disease Alcohol-associated liver disease (ALD) | 15 Participants |
| Etiology of Liver Disease Autoimmune Hepatitis (AIH) | 6 Participants |
| Etiology of Liver Disease Hepatitis C (HCV) | 10 Participants |
| Etiology of Liver Disease Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) | 10 Participants |
| Etiology of Liver Disease Other | 13 Participants |
| Model for End-Stage Liver Disease Sodium Score (MELD-Na) | 16.9 units on a scale STANDARD_DEVIATION 5.8 |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Race/Ethnicity, Customized Black | 4 Participants |
| Race/Ethnicity, Customized Hispanic | 1 Participants |
| Race/Ethnicity, Customized White | 47 Participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 81 |
| other Total, other adverse events | 0 / 81 |
| serious Total, serious adverse events | 0 / 81 |
Outcome results
None listed