Back to resultsEffects of Aerobic Training on Exercise Capacity in Patients With Cirrhosis
Primary Purpose
Cirrhosis
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Aerobic exercise
Usual Care
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 A or B
- If required, primary or secondary variceal prophylaxis in place
Exclusion Criteria:
- Post-liver transplantation
- Hepatocellular carcinoma
- Active non-Hepatocellular carcinoma malignancy
- Significant cardiac disease - ejection fraction <60% or known coronary artery disease
- Oxygen saturation at rest <95%
- Known myopathy
- Hemoglobin (<100 g/L)
- 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 and 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 VO2)
Secondary Outcome Measures
Change in muscle mass as measured by thigh ultrasound
Change in Quality of Life - Chronic Liver Disease Questionnaire
Full Information
NCT ID
NCT01799785
First Posted
February 8, 2013
Last Updated
October 8, 2013
Sponsor
University of Alberta
1. Study Identification
Unique Protocol Identification Number
NCT01799785
Brief Title
Effects of Aerobic Training on Exercise Capacity in Patients With Cirrhosis
Official Title
Aerobic Training in Patients With Cirrhosis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
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 or 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 cirrhosis. The safety of this intervention also requires further study. Using a randomized controlled design, the investigators aim to conduct a pilot study evaluating the safety and efficacy of eight weeks of aerobic exercise training on aerobic capacity.
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
20 (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 and 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 for 8 weeks (3 times per week, 30-60 minutes each session)
Intervention Type
Other
Intervention Name(s)
Usual Care
Primary Outcome Measure Information:
Title
Change in peak exercise pulmonary oxygen uptake (peak VO2)
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 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 A or B
If required, primary or secondary variceal prophylaxis in place
Exclusion Criteria:
Post-liver transplantation
Hepatocellular carcinoma
Active non-Hepatocellular carcinoma malignancy
Significant cardiac disease - ejection fraction <60% or known coronary artery disease
Oxygen saturation at rest <95%
Known myopathy
Hemoglobin (<100 g/L)
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
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
Citations:
PubMed Identifier
24768811
Citation
Zenith L, Meena N, Ramadi A, Yavari M, Harvey A, Carbonneau M, Ma M, Abraldes JG, Paterson I, Haykowsky MJ, Tandon P. Eight weeks of exercise training increases aerobic capacity and muscle mass and reduces fatigue in patients with cirrhosis. Clin Gastroenterol Hepatol. 2014 Nov;12(11):1920-6.e2. doi: 10.1016/j.cgh.2014.04.016. Epub 2014 Apr 24.
Results Reference
derived
Learn more about this trial
Effects of Aerobic Training on Exercise Capacity in Patients With Cirrhosis
We'll reach out to this number within 24 hrs