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OpenTrials
Completed

NCT Number: NCT01960127

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

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.

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Key information

Conditions

Cirrhosis Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta, Mazankowski Heart Institute

Edmonton, Alberta, T6G2B1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic Exercise

Behavioral

Aerobic exercise

No intervention

Behavioral

No Intervention

Primary outcomes

  1. Change in peak exercise pulmonary oxygen uptake (peak V02)

    Time frame: Baseline (day1) and Study End (8 weeks)

Secondary outcomes

  1. Change in muscle mass as measured by thigh ultrasound

    Time frame: Baseline (day 1) and Study End (8 weeks)

  2. Change in quality of life-Chronic Liver Disease Questionnaire

    Time frame: Baseline (day1) and Study End (8 weeks)

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Oct 10, 2013
Registry last updated
May 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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