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

Primary Purpose

Liver Cirrhosis

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Nutrition and strength training
Nutrition
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis focused on measuring Malnutrition, Muscle mass, Nutrition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Hepatology and Gastroenterology V, Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Nutrition

Nutrition and strength training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Nutritional status as measured by Triceps skinfold thickness (TSF), mid-upper-arm circumference (MUAC), mid-arm muscle area (MAMA) and hand dynamometer
Readmissions as measured by a follow-up one year after the intervention.
Quality of Life as measured by a standardized questionnaire (SF-36)
Insulin sensitivity as measured by HOMA-IR
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.
Muscle mass as measured by MRi scan and bioimpedance scan.

Full Information

First Posted
January 9, 2015
Last Updated
November 17, 2017
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02343653
Brief Title
The Effect of Resistance Training on Muscle Strength and Nutritional Status in Patients With Liver Cirrhosis
Official Title
The Effect of Resistance Training on Muscle Strength and Nutritional Status in Patients With Liver Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis
Keywords
Malnutrition, Muscle mass, Nutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nutrition
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Nutrition and strength training
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Nutrition and strength training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Nutritional status as measured by Triceps skinfold thickness (TSF), mid-upper-arm circumference (MUAC), mid-arm muscle area (MAMA) and hand dynamometer
Time Frame
12-14 weeks
Title
Readmissions as measured by a follow-up one year after the intervention.
Time Frame
1-1,5 year
Title
Quality of Life as measured by a standardized questionnaire (SF-36)
Time Frame
12-14 weeks
Title
Insulin sensitivity as measured by HOMA-IR
Time Frame
12-14 weeks
Title
Ammonia metabolism as measured by Oral Glutamine Challenge Test
Description
Minimal risk in the taking of blood samples. The participant can experience nausea and dizziness but will not be left unsupervised during the test.
Time Frame
12-14 weeks
Title
Muscle mass as measured by MRi scan and bioimpedance scan.
Time Frame
12-14weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niels Kristian Aagaard, Chief phys.
Organizational Affiliation
Department of Hepatology and Gastroenterology V, Aarhus University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Department of Hepatology and Gastroenterology V, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
31394282
Citation
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.
Results Reference
derived

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

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