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.

Study Overview

• Status: Completed
• Conditions: Cirrhosis
• Intervention / Treatment: Behavioral: Aerobic Exercise; Behavioral: No Intervention

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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)	Baseline (day1) and Study End (8 weeks)

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

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: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: LZPTMH2.0