Effects of Home Based Exercise Therapy in Early Cirrhosis

April 1, 2022 updated by: University of Alberta

An 8 Week Randomized Controlled Trial Assessing Home 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G2B1
        • University of Alberta, Mazankowski Heart Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Home based aerobic exercise
Home based aerobic exercise on cycle ergometer. Three times per week, 30-60 minutes per session.
Behavioral: Home based Aerobic exercise training
NO_INTERVENTION: Usual Care group
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?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (ACTUAL)

October 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

October 14, 2014

First Submitted That Met QC Criteria

October 14, 2014

First Posted (ESTIMATE)

October 17, 2014

Study Record Updates

Last Update Posted (ACTUAL)

April 11, 2022

Last Update Submitted That Met QC Criteria

April 1, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CKPTMHLivCirHomeTraining

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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