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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• Presence of cirrhosis.

• Over 50 years old.

• Liver Frailty Index of 3.2 points or more.

• Ability to follow instructions.

• Ability to consent to study entry.

Locations
Other Locations
Chile
Pontificia Universidad Catolica de Chile
RECRUITING
Santiago
Contact Information
Primary
Diego Reyes, Dr.
diegoreyesplacencia@gmail.com
+56974686699
Time Frame
Start Date: 2023-02-01
Estimated Completion Date: 2023-12-01
Participants
Target number of participants: 80
Treatments
No_intervention: Control group
The control group will receive written, detailed, and standardized instructions on nutritional recommendations and physical activity at visit 1. Patients will have follow-up evaluations by a physician to reinforce adherence and make necessary adjustments for compliance with nutritional requirements. Nutritional intake reminder surveys will be conducted during the last 24 hours (E24H) at weeks 0, 4, 8 and 12.
Experimental: Intervention group
Intervention group consisting of physical therapy guided by a kinesiologist for 10 sessions during which the patient will be trained to maintain physical activity three times a week. In addition, patients will be evaluated by a nutritionist who will give specific indications regarding the quality, quantity, and timing of food intake, as well as the daily frequency of food consumption. Patients will have two follow-ups by a nutritionist (week 4 and 8) to check adherence and make the necessary adjustments to meet nutritional requirements. Nutritional intake reminder surveys will be conducted during the last 24 hours (E24H) at weeks 0, 4, 8 and 12.)
Sponsors
Leads: Pontificia Universidad Catolica de Chile

This content was sourced from clinicaltrials.gov