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Trial record 20 of 1236 for:    "North American Indian childhood cirrhosis" OR "Liver Cirrhosis"

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 : 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

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.

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Behavioral: Nutrition and strength training Behavioral: Nutrition Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Resistance Training on Muscle Strength and Nutritional Status in Patients With Liver Cirrhosis
Actual Study Start Date : January 2015
Actual Primary Completion Date : July 2017
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Arm Intervention/treatment
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.
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.


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.
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.





Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. Readmissions as measured by a follow-up one year after the intervention. [ Time Frame: 1-1,5 year ]
  3. Quality of Life as measured by a standardized questionnaire (SF-36) [ Time Frame: 12-14 weeks ]
  4. Insulin sensitivity as measured by HOMA-IR [ Time Frame: 12-14 weeks ]
  5. 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.

  6. Muscle mass as measured by MRi scan and bioimpedance scan. [ Time Frame: 12-14weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02343653


Locations
Denmark
Department of Hepatology and Gastroenterology V, Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Investigators
Study Director: Niels Kristian Aagaard, Chief phys. Department of Hepatology and Gastroenterology V, Aarhus University Hospital

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02343653     History of Changes
Other Study ID Numbers: Training/Cirrhosis
First Posted: January 22, 2015    Key Record Dates
Last Update Posted: November 20, 2017
Last Verified: November 2017

Keywords provided by University of Aarhus:
Malnutrition
Muscle mass
Nutrition

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases