Coginitive DysfunctionNCT06749340
Examining the Effects of Different Resistive Exercise Programs in Individuals With Compensated Liver Cirrhosis
A study testing Assigned Interventions, Face-to-face Exercise and Home-based Exercise in people with Coginitive Dysfunction and Compensated Liver Cirrhosis, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial summary
Reasons such as sleep disorders, depression, decreased independence in daily living activities and decreased quality of life, which are seen in the majority of liver cirrhosis patients, can cause cognitive dysfunction, especially attention. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Coginitive Dysfunction, Compensated Liver Cirrhosis, Physical Dysfunction
- What is being tested?
- Assigned Interventions, Face-to-face Exercise and Home-based Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Feb 2026to 23 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being between the ages of 40 and 65;
- Being diagnosed with liver cirrhosis;
- Not having had a liver transplant;
- Being cooperative;
- Volunteering to participate in the study;
- Having a smart device (phone/tablet/computer);
- Having internet access;
- Modified Child-Turcotte-Pugh Score to be A and B.
Who cannot join
- Having a disease that may affect cognitive functions;
- Having an orthopedic, neurological, psychological, cardiac, renal or pulmonary disease;
- Having a physical or mental disability;
- Having a communication problem;
- Being unable to read or write;
- Modified Child-Turcotte-Pugh Score to be C.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Sivas Cumhuriyet University
Sivas, 58140
Mustafa Oğuz Kethüdaoğlu, +905544169776, mustafaoguzkethudaoglu@gmail.com
Mustafa Oğuz Kethüdaoğlu
About this study
Official title: Examination of the Effects of Face-to-Face and Home-Based Resistive Exercise Program on Muscle Strength, Muscle Mass and Cognitive Functions in Individuals With Compensated Liver Cirrhosis: Randomized Controlled Single -Blind Study
Reasons such as sleep disorders, depression, decreased independence in daily living activities and decreased quality of life, which are seen in the majority of liver cirrhosis patients, can cause cognitive dysfunction, especially attention. It is known that physical dysfunctions are observed in patients with liver cirrhosis along with cognitive dysfunction. Sarcopenia is the most important of these dysfunctions. Sarcopenia is the progressive, widespread loss of muscle mass, function and strength. The aim of this study is to determine the effects of face-to-face and home-based progressive strengthening exercise program performed 3 times a week for 12 weeks on muscle strength, muscle mass, functionality and cognitive functions in individuals with liver cirrhosis. It is also aimed to test the feasibility and effectiveness of the home-based exercise method in individuals with liver cirrhosis. Another aim of our study is to determine the exercise dose required to improve muscle strength, muscle mass, functionality and cognitive functions in individuals with liver cirrhosis and the duration of treatment effectiveness through follow-up.
Read the detailed description
Reasons such as sleep disorders, depression, decreased independence in daily living activities and decreased quality of life, which are seen in the majority of liver cirrhosis patients, can cause cognitive dysfunction, especially attention. And also, the most typical finding of hepatic encephalopathy is cognitive dysfunction. It is known that hepatic encephalopathy impairs attention, orientation, coordination abilities and slows down information processing processes. It is known that physical dysfunctions are observed in patients with liver cirrhosis along with cognitive dysfunction. Sarcopenia is the most important of these dysfunctions. Sarcopenia is the progressive, widespread loss of muscle mass, function and strength. The European Working Group on Sarcopenia in Older People defined sarcopenia in 2010 as a syndrome characterized by progressive and widespread loss of muscle mass and strength, associated with risks such as physical disability, low quality of life, and death. The rate of sarcopenia development in individuals with liver cirrhosis is around 70%. Sarcopenia has been described primarily in association with old age. Sarcopenia seen in cirrhosis is classified as secondary sarcopenia associated with disease, insufficient physical activity or malnutrition. Exercise may be the most effective intervention for sarcopenic individuals. It is well known that exercise has a positive effect on muscle mass, muscle strength and physical performance. And also, exercise has been proven to be effective in improving cognitive functions, which can improve mental state such as depression and insomnia stress. The aim of this study is to determine the effects of face-to-face and home-based progressive strengthening exercise program performed 3 times a week for 12 weeks on muscle strength, muscle mass, functionality and cognitive functions in individuals with liver cirrhosis. It is also aimed to test the feasibility and effectiveness of the home-based exercise method in individuals with liver cirrhosis. Another aim of our study is to determine the exercise dose required to improve muscle strength, muscle mass, functionality and cognitive functions in individuals with liver cirrhosis and the duration of treatment effectiveness through follow-up.
- Being tested
- Assigned Interventions, Face-to-face Exercise, Home-based Exercise
- Keywords
- cirrhosis, cognitive dysfunction, sarcopenia, strengthening, telerehabilitation
- Medical subject headings
- Sarcopenia, Fibrosis, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assigned InterventionsOther
Psychometric Hepatic Encephalopathy Scoring (PHES) Test
- Digit Symbol Test
- Number Combination Test-A
- Number Combination Test-B
- Serial Punctuation Test
- Line Drawing Test 6 Minute Walk Test 5 Times Sit and Stand Test
Manual Muscle Test
Hand Grip Strength Test
Quadriceps muscle thickness measurement with ultrasonography
All evaluations will be repeated 5 times.
Face-to-face ExerciseOther
Participants will undergo exercise sessions 3 days a week for 12 weeks. Sessions will include a warm-up, upper and lower extremity strengthening (1/3 set - 8/12 repetitions) and cool-down program. Theraband will be used in strengthening exercises. Theraband offers different resistance levels with its different colors. In order from lightest to heaviest; skin color, yellow, red, green, blue, black, grey, gold. Exercises (theraband color, intensity, number of sets and repetitions) will be made into a personalized program according to the tolerance level of the participants in the first session. Exercise intensity will be determined using the OMNI - Resistance Exercise Scale (OMNI - RES). The warm-up and cool-down periods in the exercise program will be carried out at levels 9 - 12 according to the Borg Scale.
Home-based ExerciseOther
Participants will follow the same program as in the face-to-face exercise group. The first meeting with the participants will be held face to face and the details of the study will be explained. Home-based exercises will be carried out with the Fiziu (Fiziu Sağlık Hizmetleri Teknoloji A.Ş., Istanbul, Türkiye) program and the exercise program will be delivered to the participants through this program. Therabands with which the participants will do their exercises will be provided by the researchers. The progression program will be determined in line with the difficulty and effort felt by the participants through weekly meetings.
| Study group | Role | What they receive |
|---|---|---|
| Face-to-face Exercise Group | Experimental | Participants will undergo exercise sessions 3 days a week for 12 weeks. Sessions will include a warm-up, upper and lower extremity strengthening (1/3 set - 8/12 repetitions) and cool-down program. Theraband will be used in strengthening exercises. Theraband offers different resistance levels with its different colors. In order from lightest to heaviest; skin color, yellow, red, green, blue, black, grey, gold. Exercises (theraband color, intensity, number of sets and repetitions) will be made into a personalized program according to the tolerance level of the participants in the first session. Exercise intensity will be determined using the OMNI - Resistance Exercise Scale (OMNI - RES). The warm-up and cool-down periods in the exercise program will be carried out at levels 9 - 12 according to the Borg Scale. Receives: Other: Assigned Interventions; Other: Face-to-face Exercise |
| Home-based Exercise Group | Experimental | Participants will follow the same program as in the face-to-face exercise group. The first meeting with the participants will be held face to face and the details of the study will be explained. Home-based exercises will be carried out with the Fiziu (Fiziu Sağlık Hizmetleri Teknoloji A.Ş., Istanbul, Türkiye) program and the exercise program will be delivered to the participants through this program. Therabands with which the participants will do their exercises will be provided by the researchers. The progression program will be determined in line with the difficulty and effort felt by the participants through weekly meetings. Receives: Other: Assigned Interventions; Other: Home-based Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Dysfunction Evaluation - Digit Symbol Test
DST is a neurophysiological test that is sensitive to brain damage, dementia and depression. It consists of a table and a list of numbers, with a symbol corresponding to each number. Under each number there is a box where the symbol corresponding to that number will be drawn. The aim is to draw as many symbols correctly as possible in the allotted time. The participant is given the page containing the digit symbol test and the following is said to the participant: "In this test, you will be shown numbers from 1 to 9 and 9 shapes corresponding to each number. We want you to draw the shape under each number in the empty box under the numbers in the table below. First, you will be asked to fill in a line for practice purposes, and then the same process will be done by keeping time. Our goal is to see how many boxes you can fill in 90 seconds." The number of symbols drawn correctly by the participant at the end of the given time is recorded.
Measured: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up
Cognitive Dysfunction Evaluation - Number Combination Test-A
NCT-A is a test that measures conscious motor ability. NCT-A measures visuospatial orientation and psychomotor speed. The patient is given two pages of NCT-A, first with the practice test and then with the actual test. "In this test, what you are asked to do is to combine the mixed numbers from 1 to 25 by drawing a line with a pencil in numerical order. The point you need to pay attention to while doing this is not to raise your hand and skip the number sequence while drawing." Then the test begins. There is no time keeping in the practice test. Afterwards, it is recorded how long it took to complete the second test.
Measured: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up
Cognitive Dysfunction Evaluation - Number Combination Test-B
In addition to NCT-A, NCT-B also evaluates the ability to sustain attention. The participant is given the page containing the NCT-B test. "In this test, similar to the NCT-A test, there are numbers from 1 to 13 and letters from A to I. What you are asked to do is to combine the mixed numbers and letters with lines in the form of one number and one letter. The point you need to pay attention to while doing this is not to raise your hand while drawing and not to skip the number-letter sequence." Then the test begins. It is recorded how long it took the participant to complete the test.
Measured: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up
Cognitive Dysfunction Evaluation - Serial Punctuation Test
SPT is a neurophysiological test that evaluates the neuromuscular system and motor control. It measures speed similarly to the LDT. The participant is given the page containing the SPT. "In this test, you are asked to put a dot in the middle of the round boxes. The point you need to pay attention to is not to skip the circles and when the line ends, continue from the left on the next line." It is recorded how many seconds the participant takes to complete the test.
Measured: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up
Cognitive Dysfunction Evaluation - Line Drawing Test
LDT, like SPT, is a test that measures motor control and speed. The participant is given the page containing the LDT. "In this test, what is required of you is to draw a path with a pencil without extending between the two lines. The point you need to pay attention to is to continue throughout the entire page without raising your hand and when you make a mistake, do not go back and try to correct it." In this test, unlike the others, both how many seconds the participants took to complete the test and how many mistakes they made are recorded as two separate parameters.
Measured: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up
Secondary outcomes (4)
Muscle Strength
Participants' muscle strength will be evaluated by manual muscle test and hand grip strength test. Baseline® Hand Dynamometer (Fabrication Enterprises Inc., NY, USA), which is a valid and reliable dynamometer, will be used in manual muscle test. Baseline® Hydraulic Hand Dynamometer (Fabrication Enterprises Inc., NY, USA), which is also a valid and reliable dynamometer, will be used to evaluate hand grip strength test. In the manual muscle test, the Quadriceps muscle, one of the antigravity muscles, will be evaluated. Participants will be asked to maintain voluntary isometric contraction for 5 seconds and the value will be recorded in kilograms. Measurements will be repeated 3 times and a 1-minute rest period will be given between each measurement and the average of 3 measurements will be recorded. Hand grip strength measurement will be performed in the sitting position, which is the standard position recommended by the American Association of Hand Therapists, with the shoulder in addu
Measured: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up
Muscle Mass
In the study published by Kara et al., it was reported that the cross-sectional area of the Quadriceps muscle was the average of the whole body. There is evidence that quadriceps muscle thickness is reduced in sarcopenic individuals. It has been emphasized that magnetic resonance imaging (MRI) and computed tomography (CT) imaging methods are superior to ultrasonography (US) imaging methods, but they have disadvantages in clinical use. US imaging method also has advantages. US imaging method is an easy, fast, safe, portable, valid (ICC: 0.92 - 0.99) and reliable (ICC: 0.88 - 0.97) alternative for measuring quadriceps muscle thickness. In our study, the muscle mass of the participants will be analyzed by evaluating the quadriceps muscle thickness with US imaging method.
Measured: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up
Functionality - 6 Minute Walk Test
In the test, the maximum walking distance within 6 minutes is evaluated. During the test, the responses of systems such as the pulmonary and cardiovascular system, systemic circulation, peripheral circulation, neuromuscular structures and muscle metabolism are generally evaluated. Participants will be asked to walk as much distance as possible along a 30-meter corridor at their maximum speed, without running or jumping. All participants will be informed about the test, the application of the test and symptoms such as palpitations, shortness of breath and sweating that may occur during the test will be mentioned. The participants will be informed that they can leave the test at any time. A wheelchair will be available in the corridor. Participants will be allowed to rest on the chair at the starting line before starting the test. The time will start as soon participants start walking. Participants will not be allowed to talk off-topic during the test. Participants will be told to stop
Measured: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up
Functionality - 5 Times Sit and Stand Test
The 5TSST was developed to measure functional lower extremity strength or to determine the movement strategies the participant uses to complete transfer skills. It is a test that measures how quickly one can move from sitting to standing 5 times in a row without using the upper extremities. In this test, participants will be seated in an armless chair, crossing their arms over their chest and without leaning their back on the backrest of the chair. The participant will be asked to sit down and stand up 5 times when "start" is said, and the stopwatch will be stopped when the participant sits on the chair for the fifth time. The test will be repeated twice, the first as practice, and the second measurement will be included in the statistical analysis.
Measured: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start19 Feb 2026 (estimated)
- Primary completion23 Dec 2026 (estimated)
- Study completion23 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coginitive DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants with liver cirrhosis will be randomly assigned to 2 groups: face-to-face exercise group and home-based exercise group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Oğuz Kethudaoglu, Bahçeşehir University
- Investigators
- Pelin Pişirici, Study director, Bahcesehir University, Department of Physiotherapy and RehabilitationMustafa Oğuz Kethüdaoğlu, Principal investigator, Sivas Cumhuriyet University,Department of Physiotherapy and Rehabilitation // Bahçeşehir University, Doctorate Program of Physiotherapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749340
- Sponsor's protocol ID
- E-10840098-202.3.02-6055 / 927
- Status last verified
- Feb 2026
- First submitted
- 12 Dec 2024
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Personal information will not be shared in accordance with the participant privacy and personal data protection law.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of the Effects of Face-to-Face and Home-Based Resistive Exercise Program on Muscle Strength, Muscle Mass and Cognitive Functions in Individuals With Compensated Liver Cirrhosis: Randomized Controlled Single -Blind Study
- ClinicalTrials.gov ID
- NCT06749340
- Acronym / sponsor ID
- E-10840098-202.3.02-6055 / 927
- Keywords
- cirrhosis, cognitive dysfunction, sarcopenia, strengthening, telerehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 19 Feb 2026 (estimated)
- Primary completion
- 23 Dec 2026 (estimated)
- Study completion
- 23 Dec 2026 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Reasons such as sleep disorders, depression, decreased independence in daily living activities and decreased quality of life, which are seen in the majority of liver cirrhosis patients, can cause cognitive dysfunction, especially attention. It is known that physical dysfunctions are observed in patients with liver cirrhosis along with cognitive dysfunction. Sarcopenia is the most important of these dysfunctions. Sarcopenia is the progressive, widespread loss of muscle mass, function and strength. The aim of this study is to determine the effects of face-to-face and home-based progressive strengthening exercise program performed 3 times a week for 12 weeks on muscle strength, muscle mass, functionality and cognitive functions in individuals with liver cirrhosis. It is also aimed to test the feasibility and effectiveness of the home-based exercise method in individuals with liver cirrhosis. Another aim of our study is to determine the exercise dose required to improve muscle strength, muscle mass, functionality and cognitive functions in individuals with liver cirrhosis and the duration of treatment effectiveness through follow-up.
Detailed description
Reasons such as sleep disorders, depression, decreased independence in daily living activities and decreased quality of life, which are seen in the majority of liver cirrhosis patients, can cause cognitive dysfunction, especially attention. And also, the most typical finding of hepatic encephalopathy is cognitive dysfunction. It is known that hepatic encephalopathy impairs attention, orientation, coordination abilities and slows down information processing processes. It is known that physical dysfunctions are observed in patients with liver cirrhosis along with cognitive dysfunction. Sarcopenia is the most important of these dysfunctions. Sarcopenia is the progressive, widespread loss of muscle mass, function and strength. The European Working Group on Sarcopenia in Older People defined sarcopenia in 2010 as a syndrome characterized by progressive and widespread loss of muscle mass and strength, associated with risks such as physical disability, low quality of life, and death. The rate of sarcopenia development in individuals with liver cirrhosis is around 70%. Sarcopenia has been described primarily in association with old age. Sarcopenia seen in cirrhosis is classified as secondary sarcopenia associated with disease, insufficient physical activity or malnutrition. Exercise may be the most effective intervention for sarcopenic individuals. It is well known that exercise has a positive effect on muscle mass, muscle strength and physical performance. And also, exercise has been proven to be effective in improving cognitive functions, which can improve mental state such as depression and insomnia stress. The aim of this study is to determine the effects of face-to-face and home-based progressive strengthening exercise program performed 3 times a week for 12 weeks on muscle strength, muscle mass, functionality and cognitive functions in individuals with liver cirrhosis. It is also aimed to test the feasibility and effectiveness of the home-based exercise method in individuals with liver cirrhosis. Another aim of our study is to determine the exercise dose required to improve muscle strength, muscle mass, functionality and cognitive functions in individuals with liver cirrhosis and the duration of treatment effectiveness through follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants with liver cirrhosis will be randomly assigned to 2 groups: face-to-face exercise group and home-based exercise group.
| Arm | Type | Receives |
|---|---|---|
| Face-to-face Exercise Group | Experimental | Other: Assigned Interventions, Other: Face-to-face ExerciseParticipants will undergo exercise sessions 3 days a week for 12 weeks. Sessions will include a warm-up, upper and lower extremity strengthening (1/3 set - 8/12 repetitions) and cool-down program. Theraband will be used in strengthening exercises. Theraband offers different resistance levels with its different colors. In order from lightest to heaviest; skin color, yellow, red, green, blue, black, grey, gold. Exercises (theraband color, intensity, number of sets and repetitions) will be made into a personalized program according to the tolerance level of the participants in the first session. Exercise intensity will be determined using the OMNI - Resistance Exercise Scale (OMNI - RES). The warm-up and cool-down periods in the exercise program will be carried out at levels 9 - 12 according to the Borg Scale. |
| Home-based Exercise Group | Experimental | Other: Assigned Interventions, Other: Home-based ExerciseParticipants will follow the same program as in the face-to-face exercise group. The first meeting with the participants will be held face to face and the details of the study will be explained. Home-based exercises will be carried out with the Fiziu (Fiziu Sağlık Hizmetleri Teknoloji A.Ş., Istanbul, Türkiye) program and the exercise program will be delivered to the participants through this program. Therabands with which the participants will do their exercises will be provided by the researchers. The progression program will be determined in line with the difficulty and effort felt by the participants through weekly meetings. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Being between the ages of 40 and 65;
- Being diagnosed with liver cirrhosis;
- Not having had a liver transplant;
- Being cooperative;
- Volunteering to participate in the study;
Key exclusion criteria (6 listed)
- Having a disease that may affect cognitive functions;
- Having an orthopedic, neurological, psychological, cardiac, renal or pulmonary disease;
- Having a physical or mental disability;
- Having a communication problem;
- Being unable to read or write;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assigned InterventionsPsychometric Hepatic Encephalopathy Scoring (PHES) Test * Digit Symbol Test * Number Combination Test-A * Number Combination Test-B * Serial Punctuation Test * Line Drawing Test 6 Minute Walk Test 5 Times Sit and Stand Test Manual Muscle Test Hand Grip Strength Test Quadriceps muscle thickness measurement with ultrasonography All evaluations will be repeated 5 times. | Other | Face-to-face Exercise Group, Home-based Exercise Group |
| Face-to-face ExerciseParticipants will undergo exercise sessions 3 days a week for 12 weeks. Sessions will include a warm-up, upper and lower extremity strengthening (1/3 set - 8/12 repetitions) and cool-down program. Theraband will be used in strengthening exercises. Theraband offers different resistance levels with its different colors. In order from lightest to heaviest; skin color, yellow, red, green, blue, black, grey, gold. Exercises (theraband color, intensity, number of sets and repetitions) will be made into a personalized program according to the tolerance level of the participants in the first session. Exercise intensity will be determined using the OMNI - Resistance Exercise Scale (OMNI - RES). The warm-up and cool-down periods in the exercise program will be carried out at levels 9 - 12 according to the Borg Scale. | Other | Face-to-face Exercise Group |
| Home-based ExerciseParticipants will follow the same program as in the face-to-face exercise group. The first meeting with the participants will be held face to face and the details of the study will be explained. Home-based exercises will be carried out with the Fiziu (Fiziu Sağlık Hizmetleri Teknoloji A.Ş., Istanbul, Türkiye) program and the exercise program will be delivered to the participants through this program. Therabands with which the participants will do their exercises will be provided by the researchers. The progression program will be determined in line with the difficulty and effort felt by the participants through weekly meetings. | Other | Home-based Exercise Group |
Primary outcome
Cognitive Dysfunction Evaluation - Digit Symbol Test
Time frame: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up
DST is a neurophysiological test that is sensitive to brain damage, dementia and depression. It consists of a table and a list of numbers, with a symbol corresponding to each number. Under each number there is a box where the symbol corresponding to that number will be drawn. The aim is to draw as many symbols correctly as possible in the allotted time. The participant is given the page containing the digit symbol test and the following is said to the participant: "In this test, you will be shown numbers from 1 to 9 and 9 shapes corresponding to each number. We want you to draw the shape under each number in the empty box under the numbers in the table below. First, you will be asked to fill in a line for practice purposes, and then the same process will be done by keeping time. Our goal is to see how many boxes you can fill in 90 seconds." The number of symbols drawn correctly by the participant at the end of the given time is recorded.
Cognitive Dysfunction Evaluation - Number Combination Test-A
Time frame: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up
NCT-A is a test that measures conscious motor ability. NCT-A measures visuospatial orientation and psychomotor speed. The patient is given two pages of NCT-A, first with the practice test and then with the actual test. "In this test, what you are asked to do is to combine the mixed numbers from 1 to 25 by drawing a line with a pencil in numerical order. The point you need to pay attention to while doing this is not to raise your hand and skip the number sequence while drawing." Then the test begins. There is no time keeping in the practice test. Afterwards, it is recorded how long it took to complete the second test.
Cognitive Dysfunction Evaluation - Number Combination Test-B
Time frame: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up
In addition to NCT-A, NCT-B also evaluates the ability to sustain attention. The participant is given the page containing the NCT-B test. "In this test, similar to the NCT-A test, there are numbers from 1 to 13 and letters from A to I. What you are asked to do is to combine the mixed numbers and letters with lines in the form of one number and one letter. The point you need to pay attention to while doing this is not to raise your hand while drawing and not to skip the number-letter sequence." Then the test begins. It is recorded how long it took the participant to complete the test.
Cognitive Dysfunction Evaluation - Serial Punctuation Test
Time frame: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up
SPT is a neurophysiological test that evaluates the neuromuscular system and motor control. It measures speed similarly to the LDT. The participant is given the page containing the SPT. "In this test, you are asked to put a dot in the middle of the round boxes. The point you need to pay attention to is not to skip the circles and when the line ends, continue from the left on the next line." It is recorded how many seconds the participant takes to complete the test.
Cognitive Dysfunction Evaluation - Line Drawing Test
Time frame: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up
LDT, like SPT, is a test that measures motor control and speed. The participant is given the page containing the LDT. "In this test, what is required of you is to draw a path with a pencil without extending between the two lines. The point you need to pay attention to is to continue throughout the entire page without raising your hand and when you make a mistake, do not go back and try to correct it." In this test, unlike the others, both how many seconds the participants took to complete the test and how many mistakes they made are recorded as two separate parameters.
4 secondary outcomes
Muscle Strength
Time frame: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up
Muscle Mass
Time frame: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up
Functionality - 6 Minute Walk Test
Time frame: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up
Functionality - 5 Times Sit and Stand Test
Time frame: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: No. Personal information will not be shared in accordance with the participant privacy and personal data protection law.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pelin Pişirici study director
Bahcesehir University, Department of Physiotherapy and Rehabilitation
Mustafa Oğuz Kethüdaoğlu principal investigator
Sivas Cumhuriyet University,Department of Physiotherapy and Rehabilitation // Bahçeşehir University, Doctorate Program of Physiotherapy and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assigned Interventions, Face-to-face Exercise and Home-based Exercise in people with Coginitive Dysfunction and Compensated Liver Cirrhosis, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mustafa Oğuz Kethüdaoğlu (+905544169776, mustafaoguzkethudaoglu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Dysfunction Evaluation - Digit Symbol Test (time frame: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.