Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04836923
Status:
RECRUITING
Last Update Posted:
2023-02-13
First Post:
2021-04-05
Brief Title:
LIFT Intervention in Liver Transplant Candidates
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Home-based Physical Therapy Intervention to Decrease Frailty in Liver Transplant Candidates
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 The investigators also aim to perform Realistic Effort Action Planning REAP which is a form of personality-informed motivational interviewing in a subset of patients to determine if this enhances the LIFT intervention
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 The investigators also aim to perform Realistic Effort Action Planning REAP which is a form of personality-informed motivational interviewing in a subset of patients to determine if this enhances the LIFT intervention
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 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 investigators will also employ Realistic Effort Action Planning REAP a form of personality-informed motivational interviewing in a subset of patients to potentially enhance patient engagement and adherence to the home-exercise prescription
The central hypothesis is that the LIFT - REAP 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
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 investigators will also employ Realistic Effort Action Planning REAP a form of personality-informed motivational interviewing in a subset of patients to potentially enhance patient engagement and adherence to the home-exercise prescription
The central hypothesis is that the LIFT - REAP 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None