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

Condition(s) studied

Investigational drug(s) / intervention(s)

Assigned Interventions: 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: 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 Exercise: 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 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.

Eligibility

Primary outcome measure(s)

• Cognitive Dysfunction Evaluation - Digit Symbol Test — 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 — 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 — 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 — 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 — 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.

Trial sites (1)

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