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

End Stage Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04220723
• Other study ID #: ESLD
• Status: Active, not recruiting
• Start date: November 20, 2022
• Est. completion date: August 16, 2024

Study information

• Verified date: April 2024
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: August 16, 2024
• Est. primary completion date: June 16, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Liver Disease
• Frailty
• Liver Diseases

Intervention

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.
• 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).

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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 — View Citation

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 Trans — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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