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Effects of Aerobic Training on Exercise Capacity in Patients With Cirrhosis

NCT ID: NCT01799785

Last Updated: 2013-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aerobic exercise

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

Group Type EXPERIMENTAL

Aerobic exercise

Intervention Type BEHAVIORAL

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

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.

Group Type PLACEBO_COMPARATOR

Usual Care

Intervention Type OTHER

Interventions

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Aerobic exercise

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

Intervention Type BEHAVIORAL

Usual Care

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Puneeta Tandon

Associate Professor Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mark Haykowsky

Role: STUDY_DIRECTOR

University of Alberta

Locations

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University of Alberta, Mazankowski Heart Institute

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 24768811 (View on PubMed)

Other Identifiers

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LZPTMH1

Identifier Type: -

Identifier Source: org_study_id