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

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01960127
• Other study ID #: LZPTMH2.0
• Status: Completed
• Phase: N/A
• Start date: October 15, 2013
• Est. completion date: May 31, 2017

Study information

• Verified date: May 2022
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 31, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Liver Cirrhosis

Intervention

Behavioral:
• Aerobic Exercise
Aerobic exercise
• No Intervention
No Intervention

Locations

Country	Name	City	State
Canada	University of Alberta, Mazankowski Heart Institute	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in peak exercise pulmonary oxygen uptake (peak V02)		Baseline (day1) and Study End (8 weeks)
Secondary	Change in muscle mass as measured by thigh ultrasound		Baseline (day 1) and Study End (8 weeks)
Secondary	Change in quality of life-Chronic Liver Disease Questionnaire		Baseline (day1) and Study End (8 weeks)