NCT05909371

Brief Summary

Liver transplantation is a life-saving treatment of choice for patients with acute or chronic liver failure. Liver transplantation is performed with a graft taken from a living donor or cadaver in patients with end-stage liver failure or who develop various complications regardless of the stage of the disease.In liver diseases, cognitive problems occur as well as physical problems. It has been observed that in some liver diseases, including hepatitis C, Wilson's disease, primary biliary cirrhosis, cognitive dysfunction that negatively affects the quality of life of patients, from mild cognitive problems to hepatic encephalopathy. Our study will be carried out in Malatya İnönü University Turgut Özal Medical Center Liver Transplant Institute Hospital in order to investigate the effects of motor-cognitive dual-task exercises on cognitive function, balance and functional capacity in liver transplant patients.It will be divided into 2 groups as classical physiotherapy and motor-cognitive exercise. Classical physiotherapy and motor-cognitive exercise programs will be applied to the groups in accordance with the clinical characteristics of the individuals, tolerable, and in a standardized manner specific to the individuals. Evaluations will be made on the first day and at the end of the twenty-fourth session while the patient is in the service before starting the treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

February 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

9 months

First QC Date

May 22, 2023

Last Update Submit

January 14, 2026

Conditions

Outcome Measures

Primary Outcomes (6)

  • Evaluation of Cognitive Functions

    The Montreal Cognitive Assessment Scale will be used to evaluate cognitive functions. The score is between 0-30 points. In order to be considered as a cognitive disorder, the participant must get a score below 21 points.

    One day

  • Evaluation of Cognitive Functions

    The Montreal Cognitive Assessment Scale will be used to evaluate cognitive functions. The score is between 0-30 points. In order to be considered as a cognitive disorder, the participant must get a score below 21 points. A day before the rehabilitation

    One day before the rehabilitation

  • Evaluation of Balance

    Functional reach and timed get-go test were used for dynamic balance assessment, and single-leg standing tests were used for static balance assessment. A day before the rehabilitation

    One day before the rehabilitation

  • Evaluation of Balance

    Functional reach and timed get-go test were used for dynamic balance assessment, and single-leg standing tests were used for static balance assessment.At the time of discharge

    One day

  • Assessment of functional capacity

    In order to determine the functional capacity, a 6-minute walking test was applied. A day before the rehabilitation

    One day before the rehabilitation

  • Assessment of functional capacity

    In order to determine the functional capacity, a 6-minute walking test was applied.At the time of discharge

    One day

Study Arms (2)

Classical physiotheraphy

EXPERIMENTAL

The Program Applied to the Classical Physiotherapy Group The Warm-Up The postural exercises Short Breathing exercises Strengthening exercises Don't sit up Daily Balance exercises Walking exercises Pre-cooling exercise An individual-specific standardized exercise program suitable for clinical characteristics will be applied to patients with a maximum of 1 set of 8-12 repetitions for 30-45 minutes for each exercise (Modified Borg scale 4-6).

Other: exercise

Motor cognitive exercise group

EXPERIMENTAL

The Program to be Applied in addition to the Physiotherapy Program to the Motor-cognitive Exercise Group .Remembering the word. Color/week/month/animal names counting/// girls boy names counting/// Country City names counting. from 50 back to 2 bad, 3 er,// counting from 50 back to 4 er//counting from 100 back to 2 bad 2 bad 3 er 3 er and simple arithmetic problems with single digits. Counting the months of the year// Counting the months of the year starting from any month// Counting the months of the year and 30 31 days.

Other: exercise

Interventions

Application of two different exercises to liver transplant individuals.

Classical physiotheraphyMotor cognitive exercise group

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be able to mobilize alone
  • Having performed a liver transplant over the age of 50
  • Spontaneous breathing
  • Being hemodynamically stable
  • Ability to read and write
  • Not having an orthopedic disability and functional capacity limitation
  • Being conscious and cooperative

You may not qualify if:

  • Not agreeing to participate in the study
  • Not continuing the treatment regularly
  • Having neurological or neuropsychiatric problems
  • Being colorblind

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, 27000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 22, 2023

First Posted

June 18, 2023

Study Start

February 1, 2023

Primary Completion

November 1, 2023

Study Completion

January 1, 2024

Last Updated

January 15, 2026

Record last verified: 2026-01

Locations