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Behavioural Intervention
Exercise for Liver Cirrhosis
N/A
Recruiting
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
This trial investigates the effects of 12 weeks of exercise (resistance or endurance) on cirrhosis patients with muscle loss and ammonia build up. Effects on body composition and fitness will be tested.
Who is the study for?
This trial is for adults aged 40-65 with cirrhosis who haven't drunk alcohol or used recreational drugs in the last 6 months. They should have a Child's score of 5-10, MELD score under 21, and no severe illnesses or medications that affect muscle mass. People with advanced heart/lung disease, recent heavy drinking, certain medication use, active cancer/infection/ascites/encephalopathy, poor clotting ability, end-stage kidney disease or those unlikely to complete the study are excluded.
What is being tested?
The study tests how resistance (strength-building) exercise twice weekly and endurance (cardiovascular health-promoting) training thrice weekly for 12 weeks affect patients with liver cirrhosis compared to standard care. It looks at changes in muscle mass and ammonia processing due to exercise by measuring fitness levels at different intervals.
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include muscle soreness or injury from resistance exercises and fatigue or cardiovascular strain from endurance training. Close supervision aims to minimize risks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: ResistanceExperimental Treatment1 Intervention
Group II: Endurance ArmExperimental Treatment1 Intervention
Group III: Standard of CareActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Resistance Exercise
2017
Completed Phase 4
~880
Find a Location
Who is running the clinical trial?
The Cleveland ClinicLead Sponsor
1,045 Previous Clinical Trials
1,370,635 Total Patients Enrolled
8 Trials studying Liver Cirrhosis
1,592 Patients Enrolled for Liver Cirrhosis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a liver transplant.I am between 40 and 65 years old.I am not taking steroids or blood clot prevention drugs.I have not had a GI bleed in the last 4 weeks.I currently have cancer.My liver function score is between 5 and 10.I currently have an infection.I have severe swelling of veins in my esophagus.I have moderate swelling in my feet above the ankle.I don't have illnesses or take medications that affect my muscle mass, diabetes, or use blood thinners.I have not had hepatic encephalopathy in the last 6 months.My heart or lung condition is severe.My kidney function is very low or I am on dialysis.I have been diagnosed with cirrhosis.
Research Study Groups:
This trial has the following groups:- Group 1: Endurance Arm
- Group 2: Resistance
- Group 3: Standard of Care
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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