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Effects of Home Based Exercise Therapy in Early Cirrhosis

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02267421
Enrollment
40
Registered
2014-10-17
Start date
2014-10-31
Completion date
2015-12-31
Last updated
2022-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis

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.

Interventions

BEHAVIORALHome based Aerobic exercise training

Sponsors

University of Alberta
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in peak exercise pulmonary oxygen uptake (VO2peak).Baseline (day 1) and Study End (8 weeks)

Secondary

MeasureTime frame
Change in muscle mass as measured by thigh ultrasoundBaseline (day 1) and Study end (8 weeks)
Change in quality of life - Chronic Liver Disease QuestionnaireBaseline (Day 1) and Study completion (8 weeks)
Change in muscle oxygen extraction and consumption as measured by MRIBaseline (day 1) and study completion (8 weeks)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026