NCT04220723

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: Hacettepe University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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. 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).

Conditions

• End Stage Liver Disease

Interventions

Type	Name	Description
OTHER	Frailty Assessment	Liver 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	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).

Timeline

• Start date: 2022-11-20
• Primary completion: 2024-06-16
• Completion: 2024-10-16
• First posted: 2020-01-07
• Last updated: 2024-10-22

Locations

1 site across 1 country: Turkey (Türkiye)