Effects of Aerobic Training on Exercise Capacity in Patients With Advanced Cirrhosis 2

May 24, 2022 updated by: University of Alberta
Cirrhosis is associated with a reduction in muscle mass and exercise capacity. This has an impact on 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 the decompensated cirrhosis patient population. The safety of this intervention also requires further study. Using a randomized controlled design, the investigators aim to determine the safety and efficacy of eight weeks of aerobic exercise training on aerobic capacity, functional performance, and muscle mass in decompensated cirrhosis patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G2B1
        • University of Alberta, Mazankowski Heart Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age >18 and ≤ 70 years
  • Cirrhosis
  • Child Pugh class B or C
  • If required, primary or secondary variceal prophylaxis in place

Exclusion Criteria:

  • Post-liver transplantation
  • Hepatocelluar carcinoma beyond transplant criteria
  • Active non-hepatocelluar 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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aerobic Exercise
Supervised aerobic training 3 times per week for 8 weeks (30-60 minute sessions)
Behavioral: Aerobic Exercise
Aerobic exercise
Placebo Comparator: Usual Care Group
These patients will continue with their normal daily activity ad will not be provided with supervised aerobic exercise training during the study period.
Behavioral: No Intervention
No Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in peak exercise pulmonary oxygen uptake (peak V02)
Time Frame: Baseline (day1) and Study End (8 weeks)
Baseline (day1) and Study End (8 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in muscle mass as measured by thigh ultrasound
Time Frame: Baseline (day 1) and Study End (8 weeks)
Baseline (day 1) and Study End (8 weeks)
Change in quality of life-Chronic Liver Disease Questionnaire
Time Frame: Baseline (day1) and Study End (8 weeks)
Baseline (day1) and Study End (8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Investigators

  • Study Director: Mark Haykowsky, PhD, University of Alberta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2013

Primary Completion (Actual)

May 31, 2017

Study Completion (Actual)

May 31, 2017

Study Registration Dates

First Submitted

October 8, 2013

First Submitted That Met QC Criteria

October 9, 2013

First Posted (Estimate)

October 10, 2013

Study Record Updates

Last Update Posted (Actual)

May 27, 2022

Last Update Submitted That Met QC Criteria

May 24, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LZPTMH2.0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe