Evaluation of Frailty and Functional Capacity in End-Stage Liver Disease

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.

Study Overview

• Status: Completed
• Conditions: End Stage Liver Disease
• Intervention / Treatment: Other: Frailty Assessment; Other: Functional Capacity Assessment

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 Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Hacettepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

The study population defined as decompanse or companse cirrhosis that caused end-stage liver disease.

Description

Inclusion Criteria:

• Follow-up with end-stage liver disease in Hacettepe University Faculty of Medicine, Department of Gastroenterology
• Volunteering for research

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Other: Frailty Assessment; 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.; Other: Functional Capacity Assessment; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	20 minutes

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Principal Investigator: Bilge Taşkın, MS PT, Hacettepe University Faculty of Physical Therapy and Rehabilitation; Study Chair: Naciye Vardar-Yağlı, PhD, Hacettepe University Faculty of Physical Therapy and Rehabilitation; Study Director: Ahmet Bülent Doğrul, MD PhD, Hacettepe University, Faculty of Medicine

Publications and helpful links

General 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.
• Duarte-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.

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2022
• Primary Completion (Actual): June 16, 2024
• Study Completion (Actual): October 16, 2024

Study Registration Dates

• First Submitted: January 5, 2020
• First Submitted That Met QC Criteria: January 6, 2020
• First Posted (Actual): January 7, 2020

Study Record Updates

• Last Update Posted (Actual): October 22, 2024
• Last Update Submitted That Met QC Criteria: October 18, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: muscle weakness; frailty; muscle strength; exercise tolerance; exercise test; end stage liver disease; hand strength
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Frailty; Liver Diseases; End Stage Liver Disease
• Other Study ID Numbers: ESLD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No