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Pulmonary Rehabilitation for Liver Disease
N/A
Recruiting
Led By Kymberly D Watt
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Wait listed for liver transplantation with poor 6 MWT
Be older than 18 years old
Must not have
Recent hospitalization (within 14 days) due to decompensation, variceal bleeding in the previous 1 month
Age < 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will test the effects of exercise on sarcopenia and frailty.
Who is the study for?
This trial is for adults on the liver transplant waiting list who have poor performance on a walking test (6 MWT). It's not suitable for those with severe heart, lung, or kidney diseases, recent heavy alcohol use, recent hospitalizations due to liver complications, certain esophageal issues without treatment, uncontrolled brain-liver connection problems (hepatic encephalopathy), specific lung-heart related liver conditions, or inability to exercise.
What is being tested?
The study is testing two types of exercises: pulmonary rehabilitation and a home-based video strengthening program. The goal is to see how these exercises affect muscle wasting and weakness in people with end-stage liver disease awaiting transplantation.
What are the potential side effects?
While the trial does not involve medication and focuses on exercise programs which are generally safe; fatigue, muscle soreness or injury could occur. Participants with advanced liver disease may also be at risk of exacerbating their condition if they overexert themselves.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am on the liver transplant list and have a poor walking test result.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I was hospitalized recently for worsening of my condition or bleeding from enlarged veins.
Select...
I am under 18 years old.
Select...
I do not have active severe liver-related brain issues.
Select...
I have large veins in my esophagus and haven't received preventive treatment.
Select...
I have a liver-lung condition causing low oxygen levels that isn't managed.
Select...
I have high blood pressure in my lungs due to liver disease.
Select...
I cannot perform physical exercises.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in 6 minute walk test
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Home based programActive Control1 Intervention
Participants will participate in a Home based Exercise program
Group II: Pulmonary RehabilitationActive Control1 Intervention
Participants will participate in formal Pulmonary Rehabilitation Exercise program
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,333 Previous Clinical Trials
3,060,122 Total Patients Enrolled
Kymberly D WattPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
19 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on the liver transplant list and have a poor walking test result.I was hospitalized recently for worsening of my condition or bleeding from enlarged veins.I am under 18 years old.I do not have active severe liver-related brain issues.I have large veins in my esophagus and haven't received preventive treatment.I have a liver-lung condition causing low oxygen levels that isn't managed.I have severe heart, lung, or kidney conditions.I have high blood pressure in my lungs due to liver disease.I cannot perform physical exercises.
Research Study Groups:
This trial has the following groups:- Group 1: Home based program
- Group 2: Pulmonary Rehabilitation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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