Back to resultsEffects of Home Based Exercise Therapy in Early Cirrhosis
Primary Purpose
Cirrhosis
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Home based Aerobic exercise training
Sponsored by
About this trial
This is an interventional treatment trial for Cirrhosis
Eligibility Criteria
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
Sites / Locations
- University of Alberta, Mazankowski Heart Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Home based aerobic exercise
Usual Care group
Arm Description
Home based aerobic exercise on cycle ergometer. Three times per week, 30-60 minutes per session.
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 .
Outcomes
Primary Outcome Measures
Change in peak exercise pulmonary oxygen uptake (VO2peak).
Secondary Outcome Measures
Change in muscle mass as measured by thigh ultrasound
Change in quality of life - Chronic Liver Disease Questionnaire
Change in muscle oxygen extraction and consumption as measured by MRI
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02267421
Brief Title
Effects of Home Based Exercise Therapy in Early Cirrhosis
Official Title
An 8 Week Randomized Controlled Trial Assessing Home Exercise Therapy in Early Cirrhosis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Home based aerobic exercise
Arm Type
Experimental
Arm Description
Home based aerobic exercise on cycle ergometer. Three times per week, 30-60 minutes per session.
Arm Title
Usual Care group
Arm Type
No Intervention
Arm Description
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 .
Intervention Type
Behavioral
Intervention Name(s)
Home based Aerobic exercise training
Primary Outcome Measure Information:
Title
Change in peak exercise pulmonary oxygen uptake (VO2peak).
Time Frame
Baseline (day 1) and Study End (8 weeks)
Secondary Outcome Measure Information:
Title
Change in muscle mass as measured by thigh ultrasound
Time Frame
Baseline (day 1) and Study end (8 weeks)
Title
Change in quality of life - Chronic Liver Disease Questionnaire
Time Frame
Baseline (Day 1) and Study completion (8 weeks)
Title
Change in muscle oxygen extraction and consumption as measured by MRI
Time Frame
Baseline (day 1) and study completion (8 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Alberta, Mazankowski Heart Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G2B1
Country
Canada
12. IPD Sharing Statement
Links:
URL
http://www.nlm.nih.gov/medlineplus/
Description
MedlinePlus
URL
http://www.nlm.nih.gov/medlineplus/cirrhosis.html
Description
MedlinePlus Cirrhosis
URL
http://www.nlm.nih.gov/medlineplus/exerciseandphysicalfitness.html
Description
MedlinePlus Exercise and Physical Fitness
URL
http://clinicaltrials.gov/ct2/info/fdalinks
Description
U.S. FDA Resources
Learn more about this trial
Effects of Home Based Exercise Therapy in Early Cirrhosis
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