Evaluation of Frailty and Functional Capacity in End-Stage Liver Disease
NCT ID: NCT04220723
Last Updated: 2024-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
40 participants
OBSERVATIONAL
2022-11-20
2024-10-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
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).
Interventions
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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.
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).
Eligibility Criteria
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Inclusion Criteria
* Volunteering for research
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Hacettepe University
OTHER
Responsible Party
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Bilge Taskin Gurel
Msc PT
Principal Investigators
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Bilge Taşkın, MS PT
Role: PRINCIPAL_INVESTIGATOR
Hacettepe University Faculty of Physical Therapy and Rehabilitation
Naciye Vardar-Yağlı, PhD
Role: STUDY_CHAIR
Hacettepe University Faculty of Physical Therapy and Rehabilitation
Ahmet Bülent Doğrul, MD PhD
Role: STUDY_DIRECTOR
Hacettepe University, Faculty of Medicine
Locations
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Hacettepe University
Ankara, , Turkey (Türkiye)
Countries
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References
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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.
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.
Other Identifiers
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ESLD
Identifier Type: -
Identifier Source: org_study_id
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