Effects of Home Based Exercise Therapy in Early Cirrhosis

NCT ID: NCT02267421

Last Updated: 2022-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Home based aerobic exercise

Home based aerobic exercise on cycle ergometer. Three times per week, 30-60 minutes per session.

Group Type EXPERIMENTAL

Home based Aerobic exercise training

Intervention Type BEHAVIORAL

Usual Care group

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 .

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Home based Aerobic exercise training

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Alberta, Mazankowski Heart Institute

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

Related Links

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Other Identifiers

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CKPTMHLivCirHomeTraining

Identifier Type: -

Identifier Source: org_study_id

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