The Effect of Resistance Training on Muscle Strength and Nutritional Status in Patients With Liver Cirrhosis

November 17, 2017 updated by: University of Aarhus
The purpose is to investigate the effect of strength training on muscle strength, muscle mass and nutritional status in patients with liver cirrhosis to clarify possible metabolic and inflammatory changes during this intervention. In addition the investigator examine if the intervention is associated with fewer hospital readmission and an improved quality of life.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Department of Hepatology and gastroenterology V, Aarhus university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Cirrhosis, Child Pugh score A and B

Exclusion Criteria:

  • Cirrhosis, Child-Pugh score C at inclusion
  • Neurological and/or psychiatric disorder
  • Pregnancy, breastfeeding
  • Patients with malignancy
  • Patients with hepatic encephalopathy at inclusion
  • Patients with atypical diets, such as vegans

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nutrition
Participants receive a controlled diet consisting of 1.2-1.5 g of protein/kg/day for 12 weeks according to guidelines for enteral nutrition and patients with cirrhosis. The group receives dietary guidance and protein supplements.
Behavioral: Nutrition

All participants will receive professional dietary guidance and a protein supplement. At the beginning and end of the intervention every participant will be part of a program consisting of:

Test of muscle strength, blood samples, assessment of nutritional status, MRi scan, test of Quality of life by questionnaire and test of the ammonium metabolism. After one year readmissions will by registered.
Experimental: Nutrition and strength training
Participants in this group receive same controlled diet consisting of 1.2-1.5 g of protein/kg/day for 12 weeks as the "No intervention"-group. Participants will also receive supervised strength training 3 x 60 min./week for 12 weeks. The group receives dietary guidance and protein supplements, which on training days should be consumed within 30 minutes after exercise.
Behavioral: Nutrition and strength training

All participants will receive professional dietary guidance and a protein supplement. At the beginning and end of the intervention every participant will be part of a program consisting of:

Test of muscle strength, blood samples, assessment of nutritional status, MRi scan, test of Quality of life by questionnaire and test of the ammonium metabolism. After one year readmissions will by registered.

The intervention group will receive supervised training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximal voluntary muscle strength in knee extensor will be measured by an isokinetic dynamometer and hand strength by hand dynamometer.
Time Frame: 12-14 weeks
12-14 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutritional status as measured by Triceps skinfold thickness (TSF), mid-upper-arm circumference (MUAC), mid-arm muscle area (MAMA) and hand dynamometer
Time Frame: 12-14 weeks
12-14 weeks
Readmissions as measured by a follow-up one year after the intervention.
Time Frame: 1-1,5 year
1-1,5 year
Quality of Life as measured by a standardized questionnaire (SF-36)
Time Frame: 12-14 weeks
12-14 weeks
Insulin sensitivity as measured by HOMA-IR
Time Frame: 12-14 weeks
12-14 weeks
Ammonia metabolism as measured by Oral Glutamine Challenge Test
Time Frame: 12-14 weeks
Minimal risk in the taking of blood samples. The participant can experience nausea and dizziness but will not be left unsupervised during the test.
12-14 weeks
Muscle mass as measured by MRi scan and bioimpedance scan.
Time Frame: 12-14weeks
12-14weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Aarhus University Hospital

Investigators

  • Study Director: Niels Kristian Aagaard, Chief phys., Department of Hepatology and gastroenterology V, Aarhus university hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

July 1, 2017

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

January 9, 2015

First Submitted That Met QC Criteria

January 15, 2015

First Posted (Estimate)

January 22, 2015

Study Record Updates

Last Update Posted (Actual)

November 20, 2017

Last Update Submitted That Met QC Criteria

November 17, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Training/Cirrhosis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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