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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01960127

Enrollment

Registered

2013-10-10

Start date

2013-10-15

Completion date

2017-05-31

Last updated

2022-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis

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.

Interventions

BEHAVIORALAerobic Exercise

Aerobic exercise

BEHAVIORALNo Intervention

No Intervention

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026