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

NCT02343653 | Unknown DMC

• 1 other identifier: Training/Cirrhosis
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhosis

Keywords

Malnutrition; Muscle mass; Nutrition

Outcome Measures

Primary Outcomes (1)

• Maximal voluntary muscle strength in knee extensor will be measured by an isokinetic dynamometer and hand strength by hand dynamometer.

  12-14 weeks

Secondary Outcomes (6)

• 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

  12-14 weeks

Study Arms (2)

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.

Behavioral: Nutrition

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.

Behavioral: Nutrition and strength training

Interventions

Nutrition and strength training 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.

Nutrition and strength training

Nutrition 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cirrhosis, Child Pugh score A and B

You may not qualify if:

• Neurological and/or psychiatric disorder
• Pregnancy, breastfeeding
• Patients with malignancy
• Patients with atypical diets, such as vegans

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Department of Hepatology and Gastroenterology V, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 31394282 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis; Malnutrition

Interventions

Nutritional Status; Resistance Training

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Niels Kristian Aagaard, Chief phys.

  Department of Hepatology and Gastroenterology V, Aarhus University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2015
• First Posted: January 22, 2015
• Study Start: January 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2018
• Last Updated: November 20, 2017

Record last verified: 2017-11

Locations

DK (1)