Effects of Aerobic Training on Exercise Capacity in Patients With Cirrhosis

NCT01799785 | Completed

• 1 other identifier: LZPTMH1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Change in peak exercise pulmonary oxygen uptake (peak VO2)

  Baseline (day 1) and Study End (8 weeks)

Secondary Outcomes (2)

• 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 (day 1) and Study End (8 weeks)

Study Arms (2)

Aerobic exercise

EXPERIMENTAL

Supervised aerobic training 3 times per week for 8 weeks (30-60 minute sessions)

Behavioral: Aerobic exercise

Usual care group

PLACEBO COMPARATOR

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

Interventions

Aerobic exercise BEHAVIORAL

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

Aerobic exercise

Usual Care OTHER

Usual care group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 and ≤70 years
• Cirrhosis
• Child Pugh class A or B
• If required, primary or secondary variceal prophylaxis in place

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta, Mazankowski Heart Institute

Edmonton, Alberta, T6G2B1, Canada

Location

Related Publications (1)

• 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.

  PMID: 24768811 DERIVED

MeSH Terms

Conditions

Fibrosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mark Haykowsky

  University of Alberta

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Medicine

Study Record Dates

• First Submitted: February 8, 2013
• First Posted: February 27, 2013
• Study Start: February 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: October 9, 2013

Record last verified: 2013-10

Locations

CA (1)