Effects of Home Based Exercise Therapy in Early Cirrhosis

Not Applicable

Completed

• Conditions: Cirrhosis
• Interventions: Behavioral: Home based Aerobic exercise training

• Registration Number: NCT02267421
• Lead Sponsor: University of Alberta

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-14
• Study First Submitted QC: 2014-10-14
• Study First Posted: 2014-10-17
• Primary Completion: 2015-10
• Study Completion: 2015-12
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-01
• Last Update Posted: 2022-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home based aerobic exercise	Home based Aerobic exercise training	Home based aerobic exercise on cycle ergometer. Three times per week, 30-60 minutes per session.

Primary Outcome Measures

Name	Time	Method
Change in peak exercise pulmonary oxygen uptake (VO2peak).	Baseline (day 1) and Study End (8 weeks)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

University of Alberta, Mazankowski Heart Institute; 🇨🇦 Edmonton, Alberta, Canada