Effects of Aerobic Training on Exercise Capacity in Patients With Advanced Cirrhosis 2
Primary Purpose
Cirrhosis
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Aerobic Exercise
No Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Cirrhosis
Eligibility Criteria
Inclusion Criteria:
- Age >18 and ≤ 70 years
- Cirrhosis
- Child Pugh class B or C
- If required, primary or secondary variceal prophylaxis in place
Exclusion Criteria:
- Post-liver transplantation
- Hepatocelluar carcinoma beyond transplant criteria
- Active non-hepatocelluar 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
Sites / Locations
- University of Alberta, Mazankowski Heart Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Aerobic Exercise
Usual Care Group
Arm Description
Supervised aerobic training 3 times per week for 8 weeks (30-60 minute sessions)
These patients will continue with their normal daily activity ad will not be provided with supervised aerobic exercise training during the study period.
Outcomes
Primary Outcome Measures
Change in peak exercise pulmonary oxygen uptake (peak V02)
Secondary Outcome Measures
Change in muscle mass as measured by thigh ultrasound
Change in quality of life-Chronic Liver Disease Questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01960127
Brief Title
Effects of Aerobic Training on Exercise Capacity in Patients With Advanced Cirrhosis 2
Official Title
Effects of Aerobic Training on Exercise Capacity in Patients With Advanced Cirrhosis 2
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 15, 2013 (Actual)
Primary Completion Date
May 31, 2017 (Actual)
Study Completion Date
May 31, 2017 (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
Cirrhosis is associated with a reduction in muscle mass and exercise capacity. This has an impact on morbidity and mortality. Regular aerobic exercise training is a proven effective therapy to improve exercise capacity in healthy and clinical populations. The effect of this training has not yet been evaluated in the decompensated cirrhosis patient population. The safety of this intervention also requires further study. Using a randomized controlled design, the investigators aim to determine the safety and efficacy of eight weeks of aerobic exercise training on aerobic capacity, functional performance, and muscle mass in decompensated cirrhosis patients.
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
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aerobic Exercise
Arm Type
Experimental
Arm Description
Supervised aerobic training 3 times per week for 8 weeks (30-60 minute sessions)
Arm Title
Usual Care Group
Arm Type
Placebo Comparator
Arm Description
These patients will continue with their normal daily activity ad will not be provided with supervised aerobic exercise training during the study period.
Intervention Type
Behavioral
Intervention Name(s)
Aerobic Exercise
Intervention Description
Aerobic exercise
Intervention Type
Behavioral
Intervention Name(s)
No Intervention
Intervention Description
No Intervention
Primary Outcome Measure Information:
Title
Change in peak exercise pulmonary oxygen uptake (peak V02)
Time Frame
Baseline (day1) 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 (day1) and Study End (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 ≤ 70 years
Cirrhosis
Child Pugh class B or C
If required, primary or secondary variceal prophylaxis in place
Exclusion Criteria:
Post-liver transplantation
Hepatocelluar carcinoma beyond transplant criteria
Active non-hepatocelluar 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Haykowsky, PhD
Organizational Affiliation
University of Alberta
Official's Role
Study Director
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
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Effects of Aerobic Training on Exercise Capacity in Patients With Advanced Cirrhosis 2
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