NCT07365098

Brief Summary

The aim of this study is to assess functional capacity in liver transplant recipients using the 30-second lie-to-sit test and to examine the relationships between functional capacity and variables such as muscle strength, upper and lower extremity function, exercise capacity, and perceived exertion.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
8mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress44%
Nov 2025Dec 2026

Study Start

First participant enrolled

November 8, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2026

Last Updated

January 26, 2026

Status Verified

November 1, 2025

Enrollment Period

12 months

First QC Date

January 15, 2026

Last Update Submit

January 15, 2026

Conditions

Keywords

liverfunctional capacityliver transplant recipients30 second lie-to-sit test

Outcome Measures

Primary Outcomes (1)

  • 30-second lie-to-sit test

    In this test, participants will be asked to start from a supine position with their head and arms supported and move to a sitting position as quickly as possible. They will be allowed to use one hand and, if necessary, a thin cushion to help them sit up. The number of repetitions performed within 30 seconds will be recorded.

    24 hours

Secondary Outcomes (11)

  • Waist Circumference

    24 hours

  • Modified Borg Scale

    24 hours

  • 30-second sit-to-stand test

    24 hours

  • Quadriceps muscle strength

    24 hours

  • Deltoid muscle strength

    24 hours

  • +6 more secondary outcomes

Interventions

In this test, participants will be asked to start from a supine position with their head and arms supported and move to a sitting position as quickly as possible. They will be allowed to use one hand and, if necessary, a thin cushion to help them sit up. The number of repetitions performed within 30 seconds will be recorded.

Following the 30-second lie-to-sit test, the modified Borg scale will be used to assess participants' perceived exertion levels.This scale is a standard tool that allows individuals to subjectively assess their level of exertion during physical activity or exercise, rated from 0 (no exertion) to 10 (maximum exertion).

Waist circumference will be measured in centimeters at the narrowest point between the lowest rib and the upper border of the pelvis while the participant is standing, and the value will be recorded.

The 30-second sit-to-stand test will be used to assess participants' lower extremity muscle strength and functional capacity. In this test, the participant sits with their back against a chair, feet flat on the floor, and arms crossed over the chest, and stands up and sits down as many times as possible within 30 seconds. Hands should not touch the chair during the test, and only full, complete repetitions are counted. The total number of repetitions at the end of the test will be recorded.

Quadriceps muscle strength will be measured isometrically using a hand-held dynamometer. The participant will be seated with the knees flexed at 90°. The dynamometer will be placed on the front of the leg at ankle level, and the participant will be asked to lift the leg with maximal effort. Three measurements will be taken for each leg, and the average value will be recorded.

Isometric strength of the deltoid muscle will be assessed using a hand-held dynamometer. The participant will be seated with the shoulder positioned at 90° abduction and the elbow slightly flexed. The dynamometer will be placed on the lateral side of the upper arm at elbow level, and the participant will perform maximum-effort shoulder abduction. Three measurements will be taken for each extremity, and the average value will be recorded.

The isometric trunk flexion strength test will be performed with the participant positioned supine, with the knees extented or the hips flexed at 30°. The dynamometer will be placed below the suprasternal notch of the sternum. The participant will place their hands on the opposite acromions and perform isometric trunk flexion.

The isometric trunk extension strength, the participant will be positioned prone while lying down. The dynamometer will be placed at the T4 level, and the participant will be asked to perform maximum isometric trunk extension. In each test position, participants will first perform a submaximal trial, followed by three correct repetitions, and the average value will be recorded.

Handgrip strength will be assessed using a hand dynamometer. Participants will be seated with their shoulders adducted at the sides, elbows flexed at 90°, forearms in a neutral position, and wrists positioned at 0-30° extension and 0-15° ulnar deviation. Three trials will be performed for each hand, with a 30-second rest between trials. For analysis, the average of three measurements for both hands will be recorded.

The 2-minute walk test will be used to assess participants' exercise capacity and physical performance. During the test, participants will walk at a self-selected, safe pace for two minutes, and the distance covered in meters will be recorded.

This questionnaire consists of 15 items that assess difficulties in using the upper extremities for activities of daily living. Each item is scored from 0 (cannot do) to 4 (no difficulty). The raw score ranges from 0 to 59 and is converted to a final score ranging from 0 to 100. A higher final score indicates better upper extremity function, providing a comprehensive assessment of functional capacity.

This questionnaire is important for assessing lower extremity functional capacity and examining activity limitations in various lower extremity disorders. It consists of 20 items, each scored from 0 (extreme difficulty or unable to perform the activity) to 4 (no difficulty). Intermediate values are defined as 1 (quite difficult), 2 (moderately difficult), and 3 (somewhat difficult). The total score ranges from 0 to 80, with higher scores indicating better functional level.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

liver transplant recipients

You may qualify if:

  • Adults aged 18-65 years
  • Diagnosed with end-stage liver disease and listed for liver transplantation
  • Ability to speak, understand, and write in Turkish
  • No mental disorders
  • Voluntary participation with informed consent

You may not qualify if:

  • Pulmonary, neurological, or cardiac diseases that may interfere with adherence to the assessment protocol
  • Difficulty complying with the assessment program
  • Musculoskeletal problems
  • History of regular physical activity
  • Multiple organ failure
  • Cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu Unıversity

Malatya, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Waist Circumference

Intervention Hierarchy (Ancestors)

Body SizeBody Weights and MeasuresBody ConstitutionPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisAnthropometryInvestigative TechniquesPhysiological Phenomena

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 15, 2026

First Posted

January 26, 2026

Study Start

November 8, 2025

Primary Completion (Estimated)

October 20, 2026

Study Completion (Estimated)

December 20, 2026

Last Updated

January 26, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations