End Stage Liver DiseaseNCT04220723
Evaluation of Frailty and Functional Capacity in End-Stage Liver Disease
An observational study of End Stage Liver Disease, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Development of fibrosis plays a main role in the pathophysiology of liver diseases. The rate of progression in fibrogenesis varies according to the type of underlying liver disease and varies with the environment and host-related factors. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- End Stage Liver Disease
- What is being tested?
- Frailty Assessment and Functional Capacity Assessment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2022to 16 Oct 2024
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population defined as decompanse or companse cirrhosis that caused end-stage liver disease.
Who may be able to join
- Follow-up with end-stage liver disease in Hacettepe University Faculty of Medicine, Department of Gastroenterology
- Volunteering for research
Who cannot join
- Presence of hepatopulmonary syndrome
- Presence of portopulmonary hypertension
- Uncontrolled severe hepatic encephalopathy
- Previous history of liver transplantation
- Presence of orthopedic problems that will affect the research
- Presence of neurological deficits
- Severe chronic obstructive pulmonary disease or heart failure
Trial locations and contacts
1 site in 1 country.
About this study
Development of fibrosis plays a main role in the pathophysiology of liver diseases. The rate of progression in fibrogenesis varies according to the type of underlying liver disease and varies with the environment and host-related factors. End-stage liver diseases are characterized by systemic vascular resistance and decreased arterial blood pressure, increased heart rate and cardiac output . Disruption of regulation of neurogenic, humoral and vascular functions is effective in these cardiovascular changes. In end-stage liver diseases, glycogen storage and corruption of glyconeogenesis cause muscle protein and fat to be used for energy, resulting in weight loss and muscle weakness. According to the latest data of the Republic of Turkey Ministry of Health in Turkey in 2223 patients are waiting for liver transplantation. Acute and chronic liver disease and infectious complications lead to an increase in the number of hospitalizations and prolonged hospital stay and severely affect the functional status and mortality. In recent years, more attention has been paid to complications from chronic diseases, including malnutrition, sarcopenia, poor functional capacity, and frailty. There are few studies in the literature examining functional capacity and physical frailty in end-stage liver disease. The aim of this study was to investigate the relationship between functional capacity and frailty in end-stage liver disease.
Read the detailed description
The decrease in functional capacity is a finding that affects quality of life in chronic liver diseases. In a study, 6 Minute Walk Test was associated with mortality in patients with cirrhosis and survival was lower in patients walking less than 250 meters. Malnutrition is a common complication of end-stage liver disease. It is a complex condition that causes loss of muscle and fat mass, loss of body weight, increased pro-inflammatory cytokines, anorexia and fatigue, resulting in sarcopenia. Sarcopenia is generally defined as a loss of muscle mass and muscle strength and is directly related to adverse outcomes in these patients. In the evaluation of malnutrition in end-stage liver disease, evaluation of skeletal muscle (mass, strength, functionality) provides an objective way to determine malnutrition, since most intrinsic markers originate from existing liver disease (eg albumin, prealbumin, lymphopenia levels).
- Conditions
- End Stage Liver Disease
- Being tested
- Frailty Assessment, Functional Capacity Assessment
- Keywords
- end stage liver disease, frailty, exercise test, muscle weakness, exercise tolerance, hand strength, muscle strength
- Medical subject headings
- End Stage Liver Disease, Frailty, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frailty AssessmentOther
Liver Frailty Index measurements:
- Grip strength: the average of three trials, measured in the subject's dominant hand using a hand dynamometer
- Timed chair stands: measured as the number of seconds it takes to do five chair stands with the subject's arms folded across the chest
- Balance testing: measured as the number of seconds that the subject can balance in three positions (feet placed side-to-side, semitandem, and tandem) for a maximum of 10 seconds each.
Functional Capacity AssessmentOther
Shuttle Walk Test: The patient is required to walk around two cones set 9 metres apart (so the final track is 10 metres) in time to a set of auditory beeps played on a CD. Initially, the walking speed is very slow, but each minute the required walking speed progressively increases. The patient walks for as long as they can until they are either too breathless or can no longer keep up with the beeps, at which time the test ends. The number of shuttles is recorded. Each shuttle represents a distance of ten metres (i.e each time the patient reaches a cone is 1 shuttle).
| Study group | Role | What they receive |
|---|---|---|
| End-Stage Liver Disease | End-stage liver disease patients who are being followed up at the Department of Gastroentereology of Hacettepe University Faculty of Medicine will be included in the study. When the participants come to the gastroenterology department for control, they will be directed to us and the assessment will begin after written and verbal approval is obtained. The Liver Frailty Index will be used to assess the frailty of the participants. Accordingly, hand grip test, 5 repeat sit-up test and side, semi-tandem and tandem balance measurements will be made and a total frailty score will be obtained. Submaximal aerobic capacities and functional capacities will be evaluated by 6 Minute Walk Test. Then, maximal inspiratory muscle pressure and maximal expiratory muscle pressure of the participants will be measured and respiratory muscle strength will be evaluated. Finally, maximal aerobic capacity will be measured by Shuttle Walk Test. Receives: Other: Frailty Assessment; Other: Functional Capacity Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty
Liver Frailty Index used to assess frailty. Accordingly, hand grip test, 5 repeat sit-up test and side, semi-tandem and tandem balance measurements will be made and a total frailty score will be obtained.
Measured: 10 minutes
Functional Capacity
Shuttle Walk Test used to assess maximal aerobic capacity. The patient is required to walk around two cones set 9 metres apart (so the final track is 10 metres) in time to a set of auditory beeps played on a CD. Initially, the walking speed is very slow, but each minute the required walking speed progressively increases. The patient walks for as long as they can until they are either too breathless or can no longer keep up with the beeps, at which time the test ends. The number of shuttles is recorded. Each shuttle represents a distance of ten metres.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start20 Nov 2022
- Primary completion16 Jun 2024
- Study completion16 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for End Stage Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilge Taskin Gurel, Hacettepe University
- Investigators
- Bilge Taşkın, MS PT, Principal investigator, Hacettepe University Faculty of Physical Therapy and RehabilitationNaciye Vardar-Yağlı, PhD, Study chair, Hacettepe University Faculty of Physical Therapy and RehabilitationAhmet Bülent Doğrul, MD PhD, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04220723
- Sponsor's protocol ID
- ESLD
- Status last verified
- Oct 2024
- First submitted
- 5 Jan 2020
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bernal W, Martin-Mateos R, Lipcsey M, Tallis C, Woodsford K, McPhail MJ, Willars C, Auzinger G, Sizer E, Heneghan M, Cottam S, Heaton N, Wendon J. Aerobic capacity during cardiopulmonary exercise testing and survival with and without liver transplantation for patients with chronic liver disease. Liver Transpl. 2014 Jan;20(1):54-62. doi: 10.1002/lt.23766. Epub 2013 Nov 29.
PubMed 24136710Duarte-Rojo A, Ruiz-Margain A, Montano-Loza AJ, Macias-Rodriguez RU, Ferrando A, Kim WR. Exercise and physical activity for patients with end-stage liver disease: Improving functional status and sarcopenia while on the transplant waiting list. Liver Transpl. 2018 Jan;24(1):122-139. doi: 10.1002/lt.24958.
PubMed 29024353
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Frailty and Functional Capacity in End-Stage Liver Disease
- ClinicalTrials.gov ID
- NCT04220723
- Acronym / sponsor ID
- ESLD
- Conditions
- End Stage Liver Disease
- Keywords
- end stage liver disease, frailty, exercise test, muscle weakness, exercise tolerance, hand strength, muscle strength
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 20 Nov 2022 (actual)
- Primary completion
- 16 Jun 2024 (actual)
- Study completion
- 16 Oct 2024 (actual)
- First posted
- 7 Jan 2020 (actual)
- 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.
Development of fibrosis plays a main role in the pathophysiology of liver diseases. The rate of progression in fibrogenesis varies according to the type of underlying liver disease and varies with the environment and host-related factors. End-stage liver diseases are characterized by systemic vascular resistance and decreased arterial blood pressure, increased heart rate and cardiac output . Disruption of regulation of neurogenic, humoral and vascular functions is effective in these cardiovascular changes. In end-stage liver diseases, glycogen storage and corruption of glyconeogenesis cause muscle protein and fat to be used for energy, resulting in weight loss and muscle weakness. According to the latest data of the Republic of Turkey Ministry of Health in Turkey in 2223 patients are waiting for liver transplantation. Acute and chronic liver disease and infectious complications lead to an increase in the number of hospitalizations and prolonged hospital stay and severely affect the functional status and mortality. In recent years, more attention has been paid to complications from chronic diseases, including malnutrition, sarcopenia, poor functional capacity, and frailty. There are few studies in the literature examining functional capacity and physical frailty in end-stage liver disease. The aim of this study was to investigate the relationship between functional capacity and frailty in end-stage liver disease.
Detailed description
The decrease in functional capacity is a finding that affects quality of life in chronic liver diseases. In a study, 6 Minute Walk Test was associated with mortality in patients with cirrhosis and survival was lower in patients walking less than 250 meters. Malnutrition is a common complication of end-stage liver disease. It is a complex condition that causes loss of muscle and fat mass, loss of body weight, increased pro-inflammatory cytokines, anorexia and fatigue, resulting in sarcopenia. Sarcopenia is generally defined as a loss of muscle mass and muscle strength and is directly related to adverse outcomes in these patients. In the evaluation of malnutrition in end-stage liver disease, evaluation of skeletal muscle (mass, strength, functionality) provides an objective way to determine malnutrition, since most intrinsic markers originate from existing liver disease (eg albumin, prealbumin, lymphopenia levels).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| End-Stage Liver Disease | – | Other: Frailty Assessment, Other: Functional Capacity AssessmentEnd-stage liver disease patients who are being followed up at the Department of Gastroentereology of Hacettepe University Faculty of Medicine will be included in the study. When the participants come to the gastroenterology department for control, they will be directed to us and the assessment will begin after written and verbal approval is obtained. The Liver Frailty Index will be used to assess the frailty of the participants. Accordingly, hand grip test, 5 repeat sit-up test and side, semi-tandem and tandem balance measurements will be made and a total frailty score will be obtained. Submaximal aerobic capacities and functional capacities will be evaluated by 6 Minute Walk Test. Then, maximal inspiratory muscle pressure and maximal expiratory muscle pressure of the participants will be measured and respiratory muscle strength will be evaluated. Finally, maximal aerobic capacity will be measured by Shuttle Walk Test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population defined as decompanse or companse cirrhosis that caused end-stage liver disease.
Key inclusion criteria (2 listed)
- Follow-up with end-stage liver disease in Hacettepe University Faculty of Medicine, Department of Gastroenterology
- Volunteering for research
Key exclusion criteria (7 listed)
- Presence of hepatopulmonary syndrome
- Presence of portopulmonary hypertension
- Uncontrolled severe hepatic encephalopathy
- Previous history of liver transplantation
- Presence of orthopedic problems that will affect the research
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 |
|---|---|---|
| Frailty AssessmentLiver Frailty Index measurements: 1. Grip strength: the average of three trials, measured in the subject's dominant hand using a hand dynamometer 2. Timed chair stands: measured as the number of seconds it takes to do five chair stands with the subject's arms folded across the chest 3. Balance testing: measured as the number of seconds that the subject can balance in three positions (feet placed side-to-side, semitandem, and tandem) for a maximum of 10 seconds each. | Other | End-Stage Liver Disease |
| Functional Capacity AssessmentShuttle Walk Test: The patient is required to walk around two cones set 9 metres apart (so the final track is 10 metres) in time to a set of auditory beeps played on a CD. Initially, the walking speed is very slow, but each minute the required walking speed progressively increases. The patient walks for as long as they can until they are either too breathless or can no longer keep up with the beeps, at which time the test ends. The number of shuttles is recorded. Each shuttle represents a distance of ten metres (i.e each time the patient reaches a cone is 1 shuttle). | Other | End-Stage Liver Disease |
Primary outcome
Frailty
Time frame: 10 minutes
Liver Frailty Index used to assess frailty. Accordingly, hand grip test, 5 repeat sit-up test and side, semi-tandem and tandem balance measurements will be made and a total frailty score will be obtained.
Functional Capacity
Time frame: 20 minutes
Shuttle Walk Test used to assess maximal aerobic capacity. The patient is required to walk around two cones set 9 metres apart (so the final track is 10 metres) in time to a set of auditory beeps played on a CD. Initially, the walking speed is very slow, but each minute the required walking speed progressively increases. The patient walks for as long as they can until they are either too breathless or can no longer keep up with the beeps, at which time the test ends. The number of shuttles is recorded. Each shuttle represents a distance of ten metres.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Results publication: PubMed 24136710Bernal W, Martin-Mateos R, Lipcsey M, Tallis C, Woodsford K, McPhail MJ, Willars C, Auzinger G, Sizer E, Heneghan M, Cottam S, Heaton N, Wendon J. Aerobic capacity during cardiopulmonary exercise testing and survival with and without liver transplantation for patients with chronic liver disease. Liver Transpl. 2014 Jan;20(1):54-62. doi: 10.1002/lt.23766. Epub 2013 Nov 29.
- Results publication: PubMed 29024353Duarte-Rojo A, Ruiz-Margain A, Montano-Loza AJ, Macias-Rodriguez RU, Ferrando A, Kim WR. Exercise and physical activity for patients with end-stage liver disease: Improving functional status and sarcopenia while on the transplant waiting list. Liver Transpl. 2018 Jan;24(1):122-139. doi: 10.1002/lt.24958.
- Individual participant dataSharing planned: No
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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.
Bilge Taşkın, MS PT principal investigator
Hacettepe University Faculty of Physical Therapy and Rehabilitation
Naciye Vardar-Yağlı, PhD study chair
Hacettepe University Faculty of Physical Therapy and Rehabilitation
Ahmet Bülent Doğrul, MD PhD study director
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Liver Disease, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 22 Oct 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Frailty (time frame: 10 minutes). The study lists 2 primary outcomes in all. 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 NCT04220723, which also lists 2 linked publications.
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 22 Oct 2024.