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

Not Applicable

• Conditions: Liver Cirrhosis
• Interventions: Behavioral: Nutrition and strength training; Behavioral: Nutrition

• Registration Number: NCT02343653
• Lead Sponsor: University of Aarhus

Brief Summary

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

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-09
• Study First Submitted QC: 2015-01-15
• Study First Posted: 2015-01-22
• Primary Completion: 2017-07
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-17
• Last Update Posted: 2017-11-20
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• Cirrhosis, Child Pugh score A and B

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutrition and strength training	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.
Nutrition	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Muscle mass as measured by MRi scan and bioimpedance scan.	12-14weeks
Ammonia metabolism as measured by Oral Glutamine Challenge Test	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.
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

Trial Locations

Locations (1)

Department of Hepatology and Gastroenterology V, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark