Frailty in Liver Transplant Exercise (FLEX) Trial

Frailty Clinical Trial

— FLEX  

Official title:

Frailty in Liver Transplant Exercise (FLEX) Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04200846
• Other study ID #: STUDY00014084
• Status: Withdrawn
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: June 2021
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Frailty
• Liver Transplants

Intervention

Behavioral:
• Exercise 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants able to complete the trial	Defined as 50% of subjects completing >80% of the sessions.	up to 52 weeks
Primary	Incidence of Treatment-Emergent Adverse Events as assessed by GCP guidelines	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.	up to 52 weeks
Primary	Rate of enrollment	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.	up to 52 weeks