Effects of Home Based Exercise Therapy in Early Cirrhosis

Cirrhosis Clinical Trial

Official title:

An 8 Week Randomized Controlled Trial Assessing Home Exercise Therapy in Early Cirrhosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02267421
• Other study ID #: CKPTMHLivCirHomeTraining
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: December 2015

Study information

• Verified date: April 2022
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Liver Cirrhosis

Intervention

Behavioral:
• Home based Aerobic exercise training

Locations

Country	Name	City	State
Canada	University of Alberta, Mazankowski Heart Institute	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in peak exercise pulmonary oxygen uptake (VO2peak).		Baseline (day 1) and Study End (8 weeks)
Secondary	Change in muscle mass as measured by thigh ultrasound		Baseline (day 1) and Study end (8 weeks)
Secondary	Change in quality of life - Chronic Liver Disease Questionnaire		Baseline (Day 1) and Study completion (8 weeks)
Secondary	Change in muscle oxygen extraction and consumption as measured by MRI		Baseline (day 1) and study completion (8 weeks)

External Links

•   MedlinePlus
•   MedlinePlus Cirrhosis
•   MedlinePlus Exercise and Physical Fitness
•   U.S. FDA Resources