Completed

Aerobic Training in Patients With Cirrhosis

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What is being tested

Aerobic exercise

+ Usual Care

BehavioralOther
Who is being recruted

Pathologic Processes

+ Pathological Conditions, Signs and Symptoms

+ Fibrosis

From 18 to 70 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: February 2013
See protocol details

Summary

Principal SponsorUniversity of Alberta
Last updated: October 9, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01799785
Principal SponsorUniversity of Alberta
Last updated: October 9, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Pathologic ProcessesPathological Conditions, Signs and SymptomsFibrosis

Criteria

4 inclusion criteria required to participate
Age >= 18 and <= 70 years
Child Pugh class A or B
Cirrhosis
If required, primary or secondary variceal prophylaxis in place
12 exclusion criteria prevent from participating
Active non-Hepatocellular carcinoma malignancy
Chronic renal failure on dialysis
HIV infection
Hemoglobin ( < 100 g/L)
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Supervised aerobic training 3 times per week for 8 weeks (30-60 minute sessions)

Group II

Placebo
These patients will continue with their normal daily activity and will not be provided with supervised aerobic exercise training during the study period.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Alberta, Mazankowski Heart Institute

Edmonton, CanadaOpen University of Alberta, Mazankowski Heart Institute in Google Maps
CompletedOne Study Center