Effects of Aerobic Training on Exercise Capacity in Patients With Advanced Cirrhosis 2

Study Overview
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Brief Summary
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Cirrhosis is associated with a reduction in muscle mass and exercise capacity. This has an impact on morbidity and mortality. Regular aerobic exercise training is a proven effective therapy to improve exercise capacity in healthy and clinical populations. The effect of this training has not yet been evaluated in the decompensated cirrhosis patient population. The safety of this intervention also requires further study. Using a randomized controlled design, the investigators aim to determine the safety and efficacy of eight weeks of aerobic exercise training on aerobic capacity, functional performance, and muscle mass in decompensated cirrhosis patients.

Official Title
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Effects of Aerobic Training on Exercise Capacity in Patients With Advanced Cirrhosis 2

Conditions
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Cirrhosis

Intervention / Treatment
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* Behavioral: Aerobic Exercise
* Behavioral: No Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 and ≤ 70 years Cirrhosis Child Pugh class B or C If required, primary or secondary variceal prophylaxis in place Exclusion Criteria: Post-liver transplantation Hepatocelluar carcinoma beyond transplant criteria Active non-hepatocelluar 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

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: Aerobic Exercise<br>Supervised aerobic training 3 times per week for 8 weeks (30-60 minute sessions) | Behavioral: Aerobic Exercise<br>* Aerobic exercise<br>|
| Placebo Comparator: Usual Care Group<br>These patients will continue with their normal daily activity ad will not be provided with supervised aerobic exercise training during the study period. | Behavioral: No Intervention<br>* No Intervention<br>|

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 (peak V02) |  | Baseline (day1) 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 (day1) and Study End (8 weeks) |