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Comparison of the Effect of Two Interventions on Liver Frailty Index in Pre-frail and Frail Cirrhotic Patients Enlisted for Liver Transplantation

NCT06149026 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-11-28

No results posted yet for this study

Summary

The goal of this prospective, double blind randomized clinical trial is to compare the effectiveness of two interventions in improve frailty (measured by Liver Frailty Index) and quality of life (measured by Chronic Liver Disease Questionnaire - CLDQ) in listed patients with cirrhosis.

The main questions it aims to answer are:

* if the intervention group (physical and nutritional therapy) could improve LFI over control group (physical and nutritional counseling).
* if the intervention group could improve secondary outcomes as CLDQ, hand grip and gait velocity.

Participants will be evaluated in a registry of basal variables such as demographic factors, weight, height and brachial circumference, comorbidities, MELD and MELD-Na, Child Pugh classification, general blood exams, etiology of cirrhosis, presence of hepatocellular carcinoma, ascites, or hepatic encephalopathy and their basal LFI, gait velocity, hand grip and CLDQ. The participants will be randomized in an intervention group or in a control group at the same time of their first evaluation and will receive the group instructions depending on what group the participants belong, and will be evaluated at 4 weeks, 8 weeks, and 12 weeks with applying LFI, measuring of gait velocity, hand grip and a nutritional survey with the intake in the last 24 hours. Finally, researchers will compare interventional group with control group if the first group could improve frailty, measured by Liver Frailty Index and the secondary outcomes with the nutritional and physical therapy.

Conditions

  • Cirrhosis, Liver

Interventions

OTHER

Physical and nutritional therapy

The patients will be evaluated and followed by a nutritionist and a physical therapist for 12 weeks. In that time, the patients will receive workouts according to their evaluations and a specific nutritional guide according to the nutritionist's evaluations.

Sponsors & Collaborators

  • Pontificia Universidad Catolica de Chile

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2023-12-01
Completion
2023-12-01

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06149026 on ClinicalTrials.gov