Effects of Home Based Exercise Therapy in Early Cirrhosis

Study Overview
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Brief Summary
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Individuals with Cirrhosis have been shown to have a low aerobic capacity. While supervised exercise training has been shown to be an effective intervention to remedy this, there is currently no data on home based exercise interventions in this population. This study will evaluate the effects of a home based exercise program on the aerobic capacity of enrolled early stage liver cirrhosis patients, as well as changes in quality of life, thigh muscle thickness, and thigh muscle oxygen consumption.

Official Title
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An 8 Week Randomized Controlled Trial Assessing Home Exercise Therapy in Early Cirrhosis

Conditions
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Cirrhosis

Intervention / Treatment
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* Behavioral: Home based Aerobic exercise training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Age >18 and less than or equal to 70 years Liver Cirrhosis Child Pugh Class A or B If required, primary or secondary Variceal prophylaxis in place Exclusion Criteria: - Post-liver transplantation Hepatocellular carcinoma beyond transplant criteria Active non-hepatocellular carcinoma malignancy Significant cardiac disease Hemoglobin (<80 g/L) Oxygen saturation at rest <95% Known myopathy Chronic renal failure on dialysis Physical impairment making it impossible to ride an exercise bike or treadmill Orthopedic abnormality preventing exercise training HIV infection Patient unwilling to consent to study Child Pugh class C

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home based aerobic exercise<br>Home based aerobic exercise on cycle ergometer. Three times per week, 30-60 minutes per session. | Behavioral: Home based Aerobic exercise training<br> <br> |
| No Intervention: Usual Care group<br>These patients will continue with their normal activities of daily living and will not be provided with equipment or coaching for home based exercise during the study period . | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in peak exercise pulmonary oxygen uptake (VO2peak). |  | Baseline (day 1) and Study End (8 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in muscle mass as measured by thigh ultrasound |  | Baseline (day 1) and Study end (8 weeks) | 
| Change in quality of life - Chronic Liver Disease Questionnaire |  | Baseline (Day 1) and Study completion (8 weeks) | 
| Change in muscle oxygen extraction and consumption as measured by MRI |  | Baseline (day 1) and study completion (8 weeks) |