Frailty in Liver Transplant Exercise (FLEX) Trial

Not Applicable

Withdrawn

• Conditions: Frailty; Liver Transplants

• Registration Number: NCT04200846
• Lead Sponsor: Milton S. Hershey Medical Center

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.

Study Timeline

• Study First Submitted: 2019-12-11
• Study First Submitted QC: 2019-12-13
• Study First Posted: 2019-12-16
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-25
• Last Update Posted: 2021-06-29
• Study Start: 2021-07-01
• Primary Completion: 2022-02-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.
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.