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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.
• Другое 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 int
• Другое 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 researche

Первичные конечные точки

• Cognitive Dysfunction Evaluation - Digit Symbol Test [Срок оценки: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up]
• Cognitive Dysfunction Evaluation - Number Combination Test-A [Срок оценки: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up]
• Cognitive Dysfunction Evaluation - Number Combination Test-B [Срок оценки: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up]
• Cognitive Dysfunction Evaluation - Serial Punctuation Test [Срок оценки: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up]
• Cognitive Dysfunction Evaluation - Line Drawing Test [Срок оценки: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up]

Вторичные конечные точки (4)

• Muscle Strength [Срок оценки: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up]
• Muscle Mass [Срок оценки: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up]
• Functionality - 6 Minute Walk Test [Срок оценки: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up]
• Functionality - 5 Times Sit and Stand Test [Срок оценки: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Sivas Cumhuriyet University — Sivas

Идентификаторы

NCT: NCT06749340 · E-10840098-202.3.02-6055 / 927

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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