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

NCT04220723 | Completed

• 1 other identifier: ESLD
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

End Stage Liver Disease

Keywords

end stage liver disease; frailty; exercise test; muscle weakness; exercise tolerance; hand strength; muscle strength

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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; Other: Functional Capacity Assessment

Interventions

Frailty Assessment OTHER

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.

End-Stage Liver Disease

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).

End-Stage Liver Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

Related 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 for patients with chronic liver disease. Liver Transpl. 2014 Jan;20(1):54-62. doi: 10.1002/lt.23766. Epub 2013 Nov 29.

  PMID: 24136710 BACKGROUND

• 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.

  PMID: 29024353 BACKGROUND

MeSH Terms

Conditions

End Stage Liver Disease; Frailty; Muscle Weakness

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Officials

• Bilge Taşkın, MS PT

  Hacettepe University Faculty of Physical Therapy and Rehabilitation

  PRINCIPAL INVESTIGATOR

• Naciye Vardar-Yağlı, PhD

  Hacettepe University Faculty of Physical Therapy and Rehabilitation

  STUDY CHAIR

• Ahmet Bülent Doğrul, MD PhD

  Hacettepe University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Msc PT

Study Record Dates

• First Submitted: January 5, 2020
• First Posted: January 7, 2020
• Study Start: November 20, 2022
• Primary Completion: June 16, 2024
• Study Completion: October 16, 2024
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)