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

Not Applicable

Completed

• Conditions: Cirrhosis
• Interventions: Behavioral: Aerobic Exercise; Behavioral: No Intervention

• Registration Number: NCT01960127
• Lead Sponsor: University of Alberta

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-08
• Study First Submitted QC: 2013-10-09
• Study First Posted: 2013-10-10
• Study Start: 2013-10-15
• Primary Completion: 2017-05-31
• Study Completion: 2017-05-31
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-24
• Last Update Posted: 2022-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in peak exercise pulmonary oxygen uptake (peak V02)	Baseline (day1) and Study End (8 weeks)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

University of Alberta, Mazankowski Heart Institute; 🇨🇦 Edmonton, Alberta, Canada