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

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ClinicalTrials.gov Identifier: NCT02343653
Recruitment Status : Unknown
Verified November 2017 by University of Aarhus.
Recruitment status was:  Active, not recruiting
First Posted : January 22, 2015
Last Update Posted : November 20, 2017
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus

Tracking Information
First Submitted Date  ICMJE January 9, 2015
First Posted Date  ICMJE January 22, 2015
Last Update Posted Date November 20, 2017
Actual Study Start Date  ICMJE January 2015
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2015)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02343653 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2015)
  • 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 ]
  • Readmissions as measured by a follow-up one year after the intervention. [ Time Frame: 1-1,5 year ]
  • Quality of Life as measured by a standardized questionnaire (SF-36) [ Time Frame: 12-14 weeks ]
  • Insulin sensitivity as measured by HOMA-IR [ Time Frame: 12-14 weeks ]
  • Ammonia metabolism as measured by Oral Glutamine Challenge Test [ Time Frame: 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.
  • Muscle mass as measured by MRi scan and bioimpedance scan. [ Time Frame: 12-14weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Resistance Training on Muscle Strength and Nutritional Status in Patients With Liver Cirrhosis
Official Title  ICMJE The Effect of Resistance Training on Muscle Strength and Nutritional Status in Patients With Liver Cirrhosis
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Liver Cirrhosis
Intervention  ICMJE
  • 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.

  • Behavioral: 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.

Study Arms  ICMJE
  • Active Comparator: 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.
    Intervention: Behavioral: Nutrition
  • Experimental: 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.
    Intervention: Behavioral: Nutrition and strength training
Publications * 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. 2019 Aug 5. pii: S1542-3565(19)30847-X. doi: 10.1016/j.cgh.2019.07.058. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: November 17, 2017)
39
Original Estimated Enrollment  ICMJE
 (submitted: January 15, 2015)
40
Estimated Study Completion Date  ICMJE July 2018
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02343653
Other Study ID Numbers  ICMJE Training/Cirrhosis
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Aarhus
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE Aarhus University Hospital
Investigators  ICMJE
Study Director: Niels Kristian Aagaard, Chief phys. Department of Hepatology and Gastroenterology V, Aarhus University Hospital
PRS Account University of Aarhus
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP