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

Study Overview
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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.

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

Conditions
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Liver Cirrhosis

Intervention / Treatment
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* Behavioral: Nutrition and strength training
* Behavioral: Nutrition


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nutrition<br>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<br>* 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.<br>|
| Experimental: Nutrition and strength training<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal voluntary muscle strength in knee extensor will be measured by an isokinetic dynamometer and hand strength by hand dynamometer. |  | 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 |  | 12-14 weeks | 
| Readmissions as measured by a follow-up one year after the intervention. |  | 1-1,5 year | 
| Quality of Life as measured by a standardized questionnaire (SF-36) |  | 12-14 weeks | 
| Insulin sensitivity as measured by HOMA-IR |  | 12-14 weeks | 
| Ammonia metabolism as measured by Oral Glutamine Challenge Test | 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. |  | 12-14weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malnutrition, Muscle mass, Nutrition