Effects of Aerobic Training on Exercise Capacity in Patients With Advanced Cirrhosis 2

NCT ID: NCT01960127

Last Updated: 2022-05-27

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

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-15

Study Completion Date

2017-05-31

Brief Summary

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Cirrhosis is associated with a reduction in muscle mass and exercise capacity. This has an impact on 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 the decompensated cirrhosis patient population. The safety of this intervention also requires further study. Using a randomized controlled design, the investigators aim to determine the safety and efficacy of eight weeks of aerobic exercise training on aerobic capacity, functional performance, and muscle mass in decompensated cirrhosis patients.

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

Usual Care Group

These patients will continue with their normal daily activity ad will not be provided with supervised aerobic exercise training during the study period.

Group Type PLACEBO_COMPARATOR

No Intervention

Intervention Type BEHAVIORAL

No Intervention

Interventions

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Aerobic Exercise

Aerobic exercise

Intervention Type BEHAVIORAL

No Intervention

No Intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age \>18 and ≤ 70 years
* Cirrhosis
* Child Pugh class B or C
* If required, primary or secondary variceal prophylaxis in place

Exclusion Criteria

* Post-liver transplantation
* Hepatocelluar carcinoma beyond transplant criteria
* Active non-hepatocelluar carcinoma malignancy
* Significant cardiac disease
* Hemoglobin (\<80 g/L)
* Oxygen saturation at rest \<95%
* Known myopathy
* 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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Responsibility Role SPONSOR

Principal Investigators

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Mark Haykowsky, PhD

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

Other Identifiers

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LZPTMH2.0

Identifier Type: -

Identifier Source: org_study_id

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