Examining the Effects of Different Resistive Exercise Programs in Individuals With Compensated Liver Cirrhosis

NCT06749340 | Not Yet Recruiting

• 1 other identifier: E-10840098-202.3.02-6055 / 927
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Coginitive Dysfunction; Compensated Liver Cirrhosis; Physical Dysfunction; Sarcopenia

Keywords

cirrhosis; cognitive dysfunction; sarcopenia; strengthening; telerehabilitation

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up

Secondary Outcomes (4)

• Muscle Strength

  Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up

• Muscle Mass

  Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up

• Functionality - 6 Minute Walk Test

  Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up

• Functionality - 5 Times Sit and Stand Test

  Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up

Study Arms (2)

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.

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.

Other: Assigned Interventions; Other: Home-based Exercise

Interventions

Assigned Interventions OTHER

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 Exercise Group; Home-based Exercise Group

Face-to-face Exercise OTHER

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.

Face-to-face Exercise Group

Home-based Exercise OTHER

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.

Home-based Exercise Group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bahçeşehir University: lead

Study Sites (1)

Sivas Cumhuriyet University

Sivas, 58140, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sarcopenia; Fibrosis; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pathologic Processes; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Pelin Pişirici

  Bahcesehir University, Department of Physiotherapy and Rehabilitation

  STUDY DIRECTOR

• Mustafa Oğuz Kethüdaoğlu

  Sivas Cumhuriyet University,Department of Physiotherapy and Rehabilitation // Bahçeşehir University, Doctorate Program of Physiotherapy and Rehabilitation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mustafa Oğuz Kethüdaoğlu

CONTACT

+905544169776; mustafaoguzkethudaoglu@gmail.com

Pelin Pişirici

CONTACT

+905055016076; pelinpisirici@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: After the first evaluation, participants will determine their groups by choosing closed and opaque envelopes. One of the researchers will perform all outcome measurements and will not know which group the participant falls into.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pirincipal Investigator; PT, MSc, PhD (c)

Model Details: Participants with liver cirrhosis will be randomly assigned to 2 groups: face-to-face exercise group and home-based exercise group.

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 27, 2024
• Study Start: February 19, 2026
• Primary Completion (Estimated): December 23, 2026
• Study Completion (Estimated): December 23, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)