Frailty in Liver Transplant Exercise (FLEX) Trial

NCT ID: NCT04200846

Last Updated: 2021-06-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2022-12-01

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.

Conditions

Frailty; Liver Transplants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercise intervention

Private supervised strength training exercise (e.g., body weight or dumbbell exercises) will occur in the Cancer Center Exercise Medicine Unit or the Hershey Center for Applied Research (HCAR) two days a week. In addition, subjects will be instructed to exercise on their own, at home, three days a week doing 30 minutes of moderate intensity aerobic exercise (e.g., walking at 45-55% maximum heart rate determined by the formula max heart rate = 220bpm - 0.64\*age in years).

Group Type: EXPERIMENTAL

Exercise intervention

Intervention Type: BEHAVIORAL

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.

Control

Subjects in the control condition will be instructed to continue their medical care at the discretion of their treating medical professional and to maintain their current exercise level. Weekly phone calls will be performed to ensure adherence to the protocol (no changes in activity). Subjects will report to Penn State on a monthly basis for interim history and physical to confirm self-reports. Subjects will also be given a FitBit ChargeHR3 and downloaded data review will be performed monthly at the in-person visits.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Stine

Assistant Professor of Medicine & Public Health Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

STUDY00014084

Identifier Type: -

Identifier Source: org_study_id