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Effects of Aerobic Training on Exercise Capacity in Patients With Cirrhosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01799785
Recruitment Status : Completed
First Posted : February 27, 2013
Last Update Posted : October 9, 2013
Sponsor:
Information provided by (Responsible Party):
Puneeta Tandon, University of Alberta

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

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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

Resource links provided by the National Library of Medicine


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



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) ]


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799785


Locations
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Canada, Alberta
University of Alberta, Mazankowski Heart Institute
Edmonton, Alberta, Canada, T6G2B1
Sponsors and Collaborators
University of Alberta
Investigators
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Study Director: Mark Haykowsky University of Alberta
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Puneeta Tandon, Associate Professor Medicine, University of Alberta
ClinicalTrials.gov Identifier: NCT01799785    
Other Study ID Numbers: LZPTMH1
First Posted: February 27, 2013    Key Record Dates
Last Update Posted: October 9, 2013
Last Verified: October 2013
Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases