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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02343653
• Other study ID #: Training/Cirrhosis
• Status: Active, not recruiting
• Phase: N/A
• First received: January 9, 2015
• Last updated: November 17, 2017
• Start date: January 2015
• Est. completion date: July 2018

Study information

• Verified date: November 2017
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 39
• Est. completion date: July 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Denmark	Department of Hepatology and Gastroenterology V, Aarhus University Hospital	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal voluntary muscle strength in knee extensor will be measured by an isokinetic dynamometer and hand strength by hand dynamometer.		12-14 weeks
Secondary	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
Secondary	Readmissions as measured by a follow-up one year after the intervention.		1-1,5 year
Secondary	Quality of Life as measured by a standardized questionnaire (SF-36)		12-14 weeks
Secondary	Insulin sensitivity as measured by HOMA-IR		12-14 weeks
Secondary	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
Secondary	Muscle mass as measured by MRi scan and bioimpedance scan.		12-14weeks