Frailty in Liver Transplant Exercise (FLEX) Trial

NCT04200846 | Withdrawn DMC

• 1 other identifier: STUDY00014084
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Frailty; Liver Transplants

Outcome Measures

Primary Outcomes (3)

• Number of participants able to complete the trial

  Defined as 50% of subjects completing \>80% of the sessions.

  up to 52 weeks

• 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

• 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

Study Arms (2)

Exercise intervention

EXPERIMENTAL

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).

Behavioral: Exercise intervention

Control

NO INTERVENTION

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.

Interventions

Exercise intervention 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.

Exercise intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults age ≥18 or ≤75 years
• Frail as defined by a LFI score of \>4.5
• Under evaluation or listed for liver transplant

You may not qualify if:

• 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)

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine & Public Health Sciences

Model Details: An interventional pilot trial will be performed with 21 randomized subjects who are aged 18-75 years who are frail according to the LFI to a 3-month exercise intervention (n=14) versus standard of care (n=7) with no change in activity.

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 16, 2019
• Study Start: July 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: December 1, 2022
• Last Updated: June 29, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share