Skip to main content
Clinical Trials/NCT02343653
NCT02343653UnknownNot Applicable

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

University of Aarhus2 sites in 1 country39 target enrollmentStarted: January 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
39
Locations
2
Primary Endpoint
Maximal voluntary muscle strength in knee extensor will be measured by an isokinetic dynamometer and hand strength by hand dynamometer.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Nutrition

Active Comparator

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.

Intervention: Nutrition (Behavioral)

Nutrition and strength training

Experimental

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.

Intervention: Nutrition and strength training (Behavioral)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Ammonia metabolism as measured by Oral Glutamine Challenge Test(12-14 weeks)
  • 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)
  • Muscle mass as measured by MRi scan and bioimpedance scan.(12-14weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

Loading locations...

Similar Trials