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

NCT ID: NCT02343653

Last Updated: 2017-11-20

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2018-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Cirrhosis

Keywords

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Malnutrition Muscle mass Nutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Nutrition

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Nutrition and strength training

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Niels Kristian Aagaard, Chief phys.

Role: STUDY_DIRECTOR

Department of Hepatology and Gastroenterology V, Aarhus University Hospital

Locations

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Department of Hepatology and Gastroenterology V, Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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Aamann L, Dam G, Borre M, Drljevic-Nielsen A, Overgaard K, Andersen H, Vilstrup H, Aagaard NK. Resistance Training Increases Muscle Strength and Muscle Size in Patients With Liver Cirrhosis. Clin Gastroenterol Hepatol. 2020 May;18(5):1179-1187.e6. doi: 10.1016/j.cgh.2019.07.058. Epub 2019 Aug 5.

Reference Type DERIVED
PMID: 31394282 (View on PubMed)

Other Identifiers

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Training/Cirrhosis

Identifier Type: -

Identifier Source: org_study_id