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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

End Stage Liver Disease Digestive System Diseases Frailty Hepatic Insufficiency Liver Diseases Liver Failure Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacettepe University

Ankara, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Frailty Assessment

Other

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 Assessment

Other

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).

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2024
First posted: Jan 7, 2020
Registry last updated: Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed