Effects of Aerobic Training on Exercise Capacity in Patients With Cirrhosis

• ClinicalTrials.gov Identifier: NCT01799785
• Recruitment Status: Completed
• First Posted: February 27, 2013
• Last Update Posted: October 9, 2013
• Sponsor: University of Alberta
• Information provided by (Responsible Party): Puneeta Tandon, University of Alberta

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Cirrhosis	Behavioral: Aerobic exercise; Other: Usual Care	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Aerobic Training in Patients With Cirrhosis
• Study Start Date: February 2013
• Actual Primary Completion Date: July 2013
• Actual Study Completion Date: July 2013

Arms and Interventions

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 for 8 weeks (3 times per week, 30-60 minutes each session)
Placebo Comparator: Usual care group; These patients will continue with their normal daily activity and will not be provided with supervised aerobic exercise training during the study period.	Other: Usual Care

Outcome Measures

Primary Outcome Measures :

1. Change in peak exercise pulmonary oxygen uptake (peak VO2) [ Time Frame: Baseline (day 1) and Study End (8 weeks) ]

Secondary Outcome Measures :

1. Change in muscle mass as measured by thigh ultrasound [ Time Frame: Baseline (day 1) and study end (8 weeks) ]
2. Change in Quality of Life - Chronic Liver Disease Questionnaire [ Time Frame: Baseline (day 1) and Study End (8 weeks) ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Canada, Alberta

University of Alberta, Mazankowski Heart Institute

Edmonton, Alberta, Canada, T6G2B1

Sponsors and Collaborators

University of Alberta

Investigators

• Study Director: Mark Haykowsky; University of Alberta

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Zenith L, Meena N, Ramadi A, Yavari M, Harvey A, Carbonneau M, Ma M, Abraldes JG, Paterson I, Haykowsky MJ, Tandon P. Eight weeks of exercise training increases aerobic capacity and muscle mass and reduces fatigue in patients with cirrhosis. Clin Gastroenterol Hepatol. 2014 Nov;12(11):1920-6.e2. doi: 10.1016/j.cgh.2014.04.016. Epub 2014 Apr 24.

• Responsible Party: Puneeta Tandon, Associate Professor Medicine, University of Alberta
• ClinicalTrials.gov Identifier: NCT01799785
• Other Study ID Numbers: LZPTMH1
• First Posted: February 27, 2013
• Last Update Posted: October 9, 2013
• Last Verified: October 2013

Additional relevant MeSH terms:

Liver Cirrhosis; Fibrosis; Pathologic Processes; Liver Diseases; Digestive System Diseases