Investigation of the Effects of Motor Cognitive Dual Task Exercises on Cognitive Function, Balance and Functional Capacity in Patients Who Have Undergone Liver Transplantation.

• ClinicalTrials.gov Identifier: NCT05909371
• Recruitment Status: Recruiting
• First Posted: June 18, 2023
• Last Update Posted: February 1, 2024
• Sponsor: Hasan Kalyoncu University
• Information provided by (Responsible Party): İlker DEMİR, Hasan Kalyoncu University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Liver Transplantation	Other: exercise	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Physiotherapy and Rehabilitation Doctoral Thesis Work
• Actual Study Start Date: February 1, 2023
• Actual Primary Completion Date: November 1, 2023
• Estimated Study Completion Date: March 1, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Classical physiotheraphy; 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 or maximum heart rate 60-70%).	Other: exercise; Application of two different exercises to liver transplant individuals.
Experimental: Motor cognitive exercise group; 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; Application of two different exercises to liver transplant individuals.

Outcome Measures

Primary Outcome Measures :

1. Evaluation of Cognitive Functions [ Time Frame: One day ]
   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.
2. Evaluation of Cognitive Functions [ Time Frame: One day before the rehabilitation ]
   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
3. Evaluation of Balance [ Time Frame: One day before the rehabilitation ]
   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
4. Evaluation of Balance [ Time Frame: One day ]
   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
5. Assessment of functional capacity [ Time Frame: One day before the rehabilitation ]
   In order to determine the functional capacity, a 6-minute walking test was applied. A day before the rehabilitation
6. Assessment of functional capacity [ Time Frame: One day ]
   In order to determine the functional capacity, a 6-minute walking test was applied.At the time of discharge

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Volunteering to participate
• 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

Exclusion Criteria:

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

Contacts and Locations

Locations

Turkey

Hasan Kalyoncu University; Recruiting

Gaziantep, Turkey, 27000

Contact: İlker Demir, PhD +905067017583 fztilkerdemir@gmail.com

Sponsors and Collaborators

Hasan Kalyoncu University

More Information

• Responsible Party: İlker DEMİR, Principal Investigator, Hasan Kalyoncu University
• ClinicalTrials.gov Identifier: NCT05909371
• Other Study ID Numbers: Hasankalyoncüüniversityilker
• First Posted: June 18, 2023
• Last Update Posted: February 1, 2024
• Last Verified: January 2024

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No