Effects of Aerobic Training on Exercise Capacity in Patients With Cirrhosis

Cirrhosis Clinical Trial

Official title:

Aerobic Training in Patients With Cirrhosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01799785
• Other study ID #: LZPTMH1
• Status: Completed
• Phase: N/A
• First received: February 8, 2013
• Last updated: October 8, 2013
• Start date: February 2013
• Est. completion date: July 2013

Study information

• Verified date: October 2013
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

Cirrhosis is associated with a reduction in muscle mass and exercise capacity. This has an impact or 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 cirrhosis. The safety of this intervention also requires further study. Using a randomized controlled design, the investigators aim to conduct a pilot study evaluating the safety and efficacy of eight weeks of aerobic exercise training on aerobic capacity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age =18 and =70 years

• Cirrhosis

• Child Pugh class A or B

• If required, primary or secondary variceal prophylaxis in place

Exclusion Criteria:

• Post-liver transplantation

• Hepatocellular carcinoma

• Active non-Hepatocellular carcinoma malignancy

• Significant cardiac disease - ejection fraction <60% or known coronary artery disease

• Oxygen saturation at rest <95%

• Known myopathy

• Hemoglobin (<100 g/L)

• 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cirrhosis
• Liver Cirrhosis

Intervention

Behavioral:
• Aerobic exercise
Aerobic exercise for 8 weeks (3 times per week, 30-60 minutes each session)

Other:
• Usual Care

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 VO2)		Baseline (day 1) and Study End (8 weeks)	No
Secondary	Change in muscle mass as measured by thigh ultrasound		Baseline (day 1) and study end (8 weeks)	No
Secondary	Change in Quality of Life - Chronic Liver Disease Questionnaire		Baseline (day 1) and Study End (8 weeks)	No