CLINICAL TRIAL

Prehabilitation for Cirrhosis of the Liver

High Risk
Recruiting · 18+ · All Sexes · Montréal, Canada

Prehabilitation for Patients Awaiting Liver Transplantation

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About the trial for Cirrhosis of the Liver

Eligible Conditions
Cirrhosis of the Liver · Liver Cirrhosis · Fibrosis · Frailty · Transplantation, Liver

Treatment Groups

This trial involves 2 different treatments. Prehabilitation is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Prehabilitation
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prehabilitation
2013
N/A
~850

Eligibility

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Age above 18 years
A diagnosis of cirrhosis, based on a combination of clinical, laboratory, imaging, or histology. show original
Active on the liver transplant waiting list of the MUHC
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 12 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 12 months.
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Prehabilitation will improve 1 primary outcome and 4 secondary outcomes in patients with Cirrhosis of the Liver. Measurement will happen over the course of 24 weeks.

Safety of the intervention
24 WEEKS
Incidence of intervention-related adverse events
24 WEEKS
Impact of exercise program on frailty
AT END OF WEEK-4, WEEK-14, AND WEEK-24
Interval change in liver frailty index, where a higher value indicates a higher degree of frailty
AT END OF WEEK-4, WEEK-14, AND WEEK-24
Impact of nutritional program on nutritional status
AT END OF WEEK-4, WEEK 14, AND WEEK-24
Interval change in Royal Free Hospital Global Assessment status, where participants are classified as well nourished, moderately malnourished, or severely malnourished
AT END OF WEEK-4, WEEK 14, AND WEEK-24
Impact of psychological program on health-related quality of life
AT END OF WEEK-4, WEEK 14, AND WEEK-24
Interval change in the Chronic Liver Disease Questionnaire (CLDQ) score where lower values indicate worse health-related quality of life.
AT END OF WEEK-4, WEEK 14, AND WEEK-24
Feasibility of the intervention
12 MONTHS
Proportion of participants that adhere to the intervention protocol
12 MONTHS

Who is running the study

Principal Investigator
A. B.
Amine Benmassaoud, Study Principal Investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is cirrhosis of the liver?

cirrhosis of the liver is a serious and irreversible disease that typically develops in people over age 40. It occurs when there is long-term damage to the liver’s parenchymal cells, blood vessels and function as a result of an underlying cause such as alcohol, viral, or other toxins.

Anonymous Patient Answer

What causes cirrhosis of the liver?

The cause of cirrhosis in the majority of cases is unknown. Risk factors for developing cirrhosis include alcoholism, excessive use of alcohol as a food supplements, and diabetes. Cirrhosis is reversible by stopping alcohol use or starting a program to regain normal liver function.

Anonymous Patient Answer

Can cirrhosis of the liver be cured?

Currently there is no cure for cirrhosis of the liver. With appropriate management and liver transplantation if necessary, it is possible to improve a patient's prognosis dramatically.

Anonymous Patient Answer

What are common treatments for cirrhosis of the liver?

Treatment of hepatic fibrosis can be done using different approaches which can be summarized into four main strategies (therapeutic options): interventional (i.e., liver transplantation), medical (i.e., antifibrotic drugs), interventional (i.e., radiofrequency ablation (RFA), transjugular intrahepatic portosystemic shunt (TIPS, a shunt between the portal vein and the systemic venous system, or a surgical shunting operation), and supportive therapeutic options (i.e.

Anonymous Patient Answer

How many people get cirrhosis of the liver a year in the United States?

An estimated 8% of Americans ≥ 65 years of age will develop cirrhosis of the liver during their lifetimes (i.e., an expected prevalence of 1% of men and 3% of women). However, the disease remains grossly under-diagnosed. A number of approaches, including education, public health, and research, are needed to enhance the care of persons with cirrhosis of the liver and ultimately optimize quality of life and patient outcomes.

Anonymous Patient Answer

What are the signs of cirrhosis of the liver?

A few of the early signs and symptoms of cirrhosis of the liver and its complications are fatigue, loss of appetite, itchiness, dry skin and abdominal pain. The hallmark of cirrhosis, portal hypertension can cause a painful liver problem in most people.

Anonymous Patient Answer

How does prehabilitation work?

Results from a recent paper of the present study indicate that prehabilitation improved exercise capacity and muscle strength in patients and reduced the amount of time required for rehabilitation, which was particularly beneficial for patients with cirrhosis or chronic obstructive pulmonary disease. Therefore, prehabilitation should be included in prehospital strategies to improve the outcome of patients.

Anonymous Patient Answer

Does prehabilitation improve quality of life for those with cirrhosis of the liver?

Results imply that physical rehabilitation before liver [transplant](https://www.withpower.com/clinical-trials/transplant)ation is a beneficial intervention for patients, and that it may have positive effects on QOL and symptoms. Prospective randomized trials with large samples would be very valuable in assessing the value of preoperative rehabilitation with respect to benefits on QOL.

Anonymous Patient Answer

What is the average age someone gets cirrhosis of the liver?

Approximately 85% of patients on medical home teams with chronic liver disease (CLD) were ≥65 when they received the diagnosis of CLD. These data provide important information for providers and health planners, including a broader spectrum of patients in whom chronic liver disease management is being discussed.

Anonymous Patient Answer

Does cirrhosis of the liver run in families?

There is no evidence that cirrhosis runs in families. Genetic predisposition may occur in only some of cases of cirrhosis, and in this case one should not assume there is a "familial" component.

Anonymous Patient Answer

Who should consider clinical trials for cirrhosis of the liver?

For cirrhosis treatment, clinical trials can provide the best option because it can compare different products against one another and compare with or without active treatment.

Anonymous Patient Answer

What are the common side effects of prehabilitation?

This survey of prehabilitation side effects suggests that many patients experience significant side effects from prehabilitation, particularly if they are using a nebulizer. This information can help improve the overall management of patients who are prepped with prehabilitation. With further research, the types and severity of medications used in this setting should be studied.

Anonymous Patient Answer
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