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Completed

NCT Number: NCT02267421

Effects of Home Based Exercise Therapy in Early Cirrhosis

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.

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Key information

Conditions

Cirrhosis Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta, Mazankowski Heart Institute

Edmonton, Alberta, T6G2B1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home based Aerobic exercise training

Behavioral

Primary outcomes

  1. Change in peak exercise pulmonary oxygen uptake (VO2peak).

    Time frame: Baseline (day 1) and Study End (8 weeks)

Secondary outcomes

  1. Change in muscle mass as measured by thigh ultrasound

    Time frame: Baseline (day 1) and Study end (8 weeks)

  2. Change in quality of life - Chronic Liver Disease Questionnaire

    Time frame: Baseline (Day 1) and Study completion (8 weeks)

  3. Change in muscle oxygen extraction and consumption as measured by MRI

    Time frame: Baseline (day 1) and study completion (8 weeks)

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 17, 2014
Registry last updated
Apr 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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