Comparing two interventions to improve frailty in cirrhotic patients awaiting liver transplantation
Comparison of the Effect of Two Interventions on Liver Frailty Index in Pre-frail and Frail Cirrhotic Patients Enlisted for Liver Transplantation
This study is testing whether a combination of physical and nutritional therapy can help frail patients with cirrhosis waiting for a liver transplant feel better compared to those who only receive counseling.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Pontificia Universidad Catolica de Chile Academic / other |
| Locations | 1 site (Santiago, Metropolitana) |
| Trial ID | NCT06149026 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of two interventions on the Liver Frailty Index in pre-frail and frail patients with cirrhosis who are on the liver transplant list. Participants will be randomized into an intervention group receiving physical and nutritional therapy or a control group receiving counseling. The study will assess improvements in frailty, quality of life, and other health metrics such as hand grip strength and gait velocity. Baseline evaluations will include demographic data, comorbidities, and various clinical assessments related to liver health.
Who should consider this trial
Good fit: Ideal candidates are individuals over 50 years old with cirrhosis and a Liver Frailty Index of 3.2 or higher.
Not a fit: Patients with advanced hepatic encephalopathy, untreated HIV, or those who have previously undergone a liver transplant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the quality of life and health outcomes for frail cirrhotic patients awaiting liver transplantation.
How similar studies have performed: Other studies have shown promising results with interventions targeting frailty in similar patient populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Presence of cirrhosis. 2. Over 50 years old. 3. Liver Frailty Index of 3.2 points or more. 4. Ability to follow instructions. 5. Ability to consent to study entry. Exclusion Criteria: 1. Grade 3 or 4 hepatic encephalopathy. 2. Untreated HIV infection. 3. Previous liver transplant. 4. Inability to walk. 5. Extrahepatic diseases that limit mobility (e.g., neurological or musculoskeletal). 6. Advanced cardiac, renal or pulmonary disease. 7. Expectation of being transplanted during the study period. 8. Hepatocarcinoma (HCC) exceeding the Milan criteria.
Where this trial is running
Santiago, Metropolitana
- Pontificia Universidad Catolica de Chile — Santiago, Metropolitana, Chile (Recruiting)
Study contacts
- Study coordinator: Diego Reyes, Dr.
- Email: diegoreyesplacencia@gmail.com
- Phone: +56974686699
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.