Liver CirrhosisNCT02343653
The Effect of Resistance Training on Muscle Strength and Nutritional Status in Patients With Liver Cirrhosis
A study testing Nutrition and strength training and Nutrition in people with Liver Cirrhosis, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Nutrition and strength training and Nutrition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2015to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cirrhosis, Child Pugh score A and B
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Hepatology and Gastroenterology V, Aarhus University Hospital
Aarhus, 8000
About this study
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
- Being tested
- Nutrition and strength training, Nutrition
- Keywords
- Malnutrition, Muscle mass, Nutrition
- Medical subject headings
- Liver Cirrhosis, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition and strength trainingBehavioural
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.
NutritionBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Nutrition and strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal voluntary muscle strength in knee extensor will be measured by an isokinetic dynamometer and hand strength by hand dynamometer.
Measured: 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
Measured: 12-14 weeks
Readmissions as measured by a follow-up one year after the intervention.
Measured: 1-1,5 year
Quality of Life as measured by a standardized questionnaire (SF-36)
Measured: 12-14 weeks
Insulin sensitivity as measured by HOMA-IR
Measured: 12-14 weeks
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.
Measured: 12-14 weeks
Muscle mass as measured by MRi scan and bioimpedance scan.
Measured: 12-14weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionJul 2017
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Niels Kristian Aagaard, Chief phys., Study director, Department of Hepatology and Gastroenterology V, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02343653
- Sponsor's protocol ID
- Training/Cirrhosis
- Status last verified
- Nov 2017
- First submitted
- 9 Jan 2015
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
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. 2020 May;18(5):1179-1187.e6. doi: 10.1016/j.cgh.2019.07.058. Epub 2019 Aug 5.
PubMed 31394282
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Resistance Training on Muscle Strength and Nutritional Status in Patients With Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT02343653
- Acronym / sponsor ID
- Training/Cirrhosis
- Conditions
- Liver Cirrhosis
- Keywords
- Malnutrition, Muscle mass, Nutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Jan 2015 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2018 (estimated)
- First posted
- 22 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutrition | Active comparator | Behavioral: NutritionParticipants 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. |
| Nutrition and strength training | Experimental | Behavioral: Nutrition and strength trainingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cirrhosis, Child Pugh score A and B
Key exclusion criteria (6 listed)
- Cirrhosis, Child-Pugh score C at inclusion
- Neurological and/or psychiatric disorder
- Pregnancy, breastfeeding
- Patients with malignancy
- Patients with hepatic encephalopathy at inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition and strength trainingAll 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. | Behavioural | Nutrition and strength training |
| NutritionAll 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. | Behavioural | Nutrition |
Primary outcome
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
6 secondary outcomes
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
Muscle mass as measured by MRi scan and bioimpedance scan.
Time frame: 12-14weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
- Derived from this study: PubMed 31394282Aamann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niels Kristian Aagaard, Chief phys. study director
Department of Hepatology and Gastroenterology V, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition and strength training and Nutrition in people with Liver Cirrhosis, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02343653, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2017.