Effects of Home Based Exercise Therapy in Early Cirrhosis
An 8 Week Randomized Controlled Trial Assessing Home Exercise Therapy in Early Cirrhosis
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 14, 2014
CompletedFirst Posted
Study publicly available on registry
October 17, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedApril 11, 2022
April 1, 2022
1 year
October 14, 2014
April 1, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change in peak exercise pulmonary oxygen uptake (VO2peak).
Baseline (day 1) and Study End (8 weeks)
Secondary Outcomes (3)
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)
Study Arms (2)
Home based aerobic exercise
EXPERIMENTALHome based aerobic exercise on cycle ergometer. Three times per week, 30-60 minutes per session.
Usual Care group
NO INTERVENTIONThese 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 .
Interventions
Eligibility Criteria
You may qualify if:
- \- 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
You may not qualify if:
- \- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alberta, Mazankowski Heart Institute
Edmonton, Alberta, T6G2B1, Canada
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2014
First Posted
October 17, 2014
Study Start
October 1, 2014
Primary Completion
October 1, 2015
Study Completion
December 1, 2015
Last Updated
April 11, 2022
Record last verified: 2022-04