What side effects are associated with this type of intervention?

Common treatments for liver cirrhosis that aim to improve physical fitness, nutritional status, and mental well-being include exercise training, nutritional optimization, and psychological support. Exercise training is generally safe but may cause muscle soreness or fatigue. Nutritional optimization, including dietary changes and supplements, can sometimes lead to gastrointestinal discomfort or nutrient imbalances. Psychological support, such as counseling or therapy, typically has minimal side effects but may cause emotional distress as patients work through challenging issues. Medications used in cirrhosis management, such as diuretics and beta-blockers, can have side effects like electrolyte imbalances, fatigue, and dizziness.

What prior FDA approvals exist?

The FDA has approved several treatments for managing liver cirrhosis, focusing on improving patients' overall health and quality of life. Ursodeoxycholic acid (UDCA) is approved for primary biliary cirrhosis, helping to improve liver function and delay disease progression. Nutritional supplements like Beta-Hydroxy-Beta-Methylbutyrate (HMB) have shown promise in improving muscle mass and strength in cirrhotic patients. Additionally, structured exercise programs and psychological support are recommended to enhance physical fitness and mental well-being, although specific FDA-approved programs for these aspects are not detailed. These treatments collectively aim to manage symptoms and improve the quality of life for patients with liver cirrhosis.

What other types of research exist?

Promising alternatives to a structured prehabilitation program for liver cirrhosis patients include: 1) Tailored exercise programs such as resistance training and aerobic exercise, which can improve physical fitness and functional status. 2) Nutritional interventions focusing on protein-calorie malnutrition and specific dietary adjustments to support liver health. 3) Psychological support through mindfulness-based stress reduction, cognitive-behavioral therapy, and social prescribing to enhance mental well-being. These approaches can be individualized based on patient needs and tolerances.

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Behavioral Intervention

Prehabilitation for Liver Transplant Candidates (Prehab preLT Trial)

N/A

Recruiting

Led By Amine Benmassaoud, MD

Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age above 18 years

Diagnosis of cirrhosis, based on a combination of clinical, laboratory, imaging, or histology

Must not have

Recurrent large volume paracentesis

High risk varices not on primary or secondary prevention

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a program combining exercise, nutrition, and mental health support can help patients with cirrhosis become stronger and healthier before their surgery.

Who is the study for?

This trial is for adults over 18 who are on the liver transplant waiting list with diagnosed cirrhosis. They must not have severe end-stage liver disease, recent hepatic decompensation, low blood counts, significant heart issues, or conditions that limit movement or cause frequent falls.

What is being tested?

The study tests a prehabilitation program for those awaiting liver transplants. It includes exercise training, nutritional support and psychological care to see if it's doable, safe and effective in improving patient outcomes before surgery.

What are the potential side effects?

Since this intervention involves lifestyle changes rather than medication, side effects may include muscle soreness from exercise and stress related to lifestyle adjustments. However specific risks will depend on individual health status.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 years old.

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I have been diagnosed with cirrhosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had multiple large fluid removals from my abdomen.

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I have high-risk varices and am not on any prevention plan.

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I am waiting for a combined organ transplant.

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My blood flow is not normal.

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I have a condition that limits my ability to move or exercise, or I often fall.

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I am waiting for another liver transplant.

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I have a serious heart condition.

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I have ongoing confusion due to liver problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility of the intervention

Secondary study objectives

Impact of exercise program on frailty

Impact of nutritional program on nutritional status

Impact of psychological program on health-related quality of life

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: PrehabilitationExperimental Treatment1 Intervention

Multimodal prehabilitation program

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prehabilitation

2013

Completed Phase 3

~1040

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The structured prehabilitation program for liver cirrhosis patients combines exercise training, nutritional optimization, and psychological support to improve overall health. Exercise training enhances physical fitness and muscle strength, which can help counteract the muscle wasting and fatigue common in cirrhosis. Nutritional optimization ensures adequate intake of essential nutrients, addressing malnutrition and improving liver function. Psychological support helps manage the mental stress and anxiety associated with chronic illness, improving overall well-being. Together, these interventions aim to enhance the patient's quality of life and potentially improve outcomes post-liver transplantation.

Pharmacotherapies that specifically target ammonia for the prevention and treatment of hepatic encephalopathy in adults with cirrhosis.Effect of non-alcoholic beer, diet and exercise on endothelial function, nutrition and quality of life in patients with cirrhosis.ASSOCIATION BETWEEN FATIGUE AND EXERCISE CAPACITY IN PATIENTS WITH CHRONIC LIVER DISEASE AWAITING LIVER TRANSPLANTATION.