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Effects of Aerobic Training on Exercise Capacity in Patients With Cirrhosis

U

University of Alberta

Status

Completed

Conditions

Cirrhosis

Treatments

Other: Usual Care
Behavioral: Aerobic exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT01799785
LZPTMH1

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups, including a placebo group

Aerobic exercise
Experimental group
Description:
Supervised aerobic training 3 times per week for 8 weeks (30-60 minute sessions)
Treatment:
Behavioral: Aerobic exercise
Usual care group
Placebo Comparator group
Description:
These patients will continue with their normal daily activity and will not be provided with supervised aerobic exercise training during the study period.
Treatment:
Other: Usual Care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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