Clinical trial NCT06749340: Examining the Effects of Different Resistive Exercise Programs in Individuals with Compensated Liver Cirrhosis
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coginitive Dysfunction
Compensated Liver Cirrhosis
Physical Dysfunction
Sarcopenia
Keywords: cirrhosis
cognitive dysfunction
sarcopenia
strengthening
telerehabilitation
Lead sponsor: Bahçeşehir University
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants with liver cirrhosis will be randomly assigned to 3 groups: face-to-face exercise group, home-based exercise group and control group.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Cognitive Dysfunction Evaluation - Digit Symbol Test
timeFrame: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up
measure: Cognitive Dysfunction Evaluation - Number Combination Test-A
timeFrame: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up
measure: Cognitive Dysfunction Evaluation - Number Combination Test-B
timeFrame: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up
measure: Cognitive Dysfunction Evaluation - Serial Punctuation Test
timeFrame: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up
measure: Cognitive Dysfunction Evaluation - Line Drawing Test
timeFrame: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up
Secondary outcomes:
measure: Muscle Strength
timeFrame: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up
measure: Muscle Mass
timeFrame: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up
measure: Functionality - 6 Minute Walk Test
timeFrame: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up
measure: Functionality - 5 Times Sit and Stand Test
timeFrame: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up
Other outcomes:
Locations:
city: Sivas
country: Turkey
facility: Sivas Cumhuriyet University
Study officials:
affiliation: Bahcesehir University, Department of Physiotherapy and Rehabilitation
name: Pelin Pişirici
role: STUDY_DIRECTOR
affiliation: Sivas Cumhuriyet University,Department of Physiotherapy and Rehabilitation // Bahçeşehir University, Doctorate Program of Physiotherapy and Rehabilitation
name: Mustafa Oğuz Kethüdaoğlu
role: PRINCIPAL_INVESTIGATOR
References: