Clinical trial NCT04220723: Evaluation of Frailty and Functional Capacity in End-Stage Liver Disease
Official title: Evaluation of Frailty and Functional Capacity in End-Stage Liver Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End Stage Liver Disease
Keywords: end stage liver disease
frailty
exercise test
muscle weakness
exercise tolerance
hand strength
muscle strength
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-01-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population defined as decompanse or companse cirrhosis that caused end-stage liver disease.

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Frailty
timeFrame: 10 minutes
measure: Functional Capacity
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University Faculty of Physical Therapy and Rehabilitation
name: Bilge Taşkın, MS PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University Faculty of Physical Therapy and Rehabilitation
name: Naciye Vardar-Yağlı, PhD
role: STUDY_CHAIR
affiliation: Hacettepe University, Faculty of Medicine
name: Ahmet Bülent Doğrul, MD PhD
role: STUDY_DIRECTOR
References:
citation: 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.
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 Transpl. 2018 Jan;24(1):122-139. doi: 10.1002/lt.24958.